Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00824005
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lemmoye@msn.com', 'phone': '713-500-9518', 'title': 'Lemuel Moye, MD, PhD', 'organization': 'UT-Houston School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Sample size was small and required large improvements in order to show significant treatment effects. SPECT often underestimates reversibility and viability in those with multivessel disease. Presence of cardiac devices limited MRI evaluation.'}}, 'adverseEventsModule': {'timeFrame': 'Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.', 'otherNumAtRisk': 31, 'otherNumAffected': 11, 'seriousNumAtRisk': 31, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.', 'otherNumAtRisk': 61, 'otherNumAffected': 19, 'seriousNumAtRisk': 61, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Tachycardia', 'notes': 'Tachycardia not requiring hospitalization or a change to current therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in BNP levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maximal Oxygen Consumption (VO2max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '2.34', 'pValueComment': 'No adjustment for multiple comparisons', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.9', 'groupDescription': 'Compare the change in the cell group to the change in the placebo group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'The VO2(max) is assessed using the Naughton treadmill protocol.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and 6 month VO2max data available are included.'}, {'type': 'PRIMARY', 'title': 'Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.856', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-10.05', 'ciUpperLimit': '12.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '23.9', 'groupDescription': 'Change in the difference of end systolic volume over time.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.', 'unitOfMeasure': 'mL/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month LVESV data available are included.'}, {'type': 'PRIMARY', 'title': 'Change in Reversible Defect Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '25.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.835', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '10.1', 'pValueComment': 'Is the change in percent reversible defect the same between the two groups', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.3', 'groupDescription': 'Change in percent of the defect that is reversible', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.', 'unitOfMeasure': 'percentage of reversible defect', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month reversible defect data available are included.'}, {'type': 'SECONDARY', 'title': 'Regional Wall Motion by MRI (in Eligible Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)', 'reportingStatus': 'POSTED', 'populationDescription': 'The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.'}, {'type': 'SECONDARY', 'title': 'Regional Blood Flow Improvement by MRI (in Eligible Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)', 'reportingStatus': 'POSTED', 'populationDescription': 'The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.'}, {'type': 'SECONDARY', 'title': 'Regional Wall Motion by Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'groupDescription': 'Difference in the change between the two groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Movement of the left ventricular wall measured in mm from baseline to six months.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month wall motion data available are included.'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement in CCS Classification (Angina Pectoris)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.784', 'groupDescription': 'Change in average improvement in Canadian Class Score over time between the two groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)"able to conduct ordinary daily activity without causing angina" to Class IV (worst) "Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest." Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month CCS data available are included.'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement in NYHA Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.176', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.845', 'groupDescription': 'Difference in the change in NYHA score between the two groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure". Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month NYHA class data available are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease in Anti-anginal Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the proportion of particip', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.045', 'groupDescription': 'Difference in the change in anti-anginal meds across groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month anti-anginal medication data available are included.'}, {'type': 'SECONDARY', 'title': 'Exercise Time and Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '415', 'groupId': 'OG000'}, {'value': '184', 'spread': '407', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '104', 'ciLowerLimit': '-95', 'ciUpperLimit': '303', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '409', 'groupDescription': 'Change in six minute walk distance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Exercise time and level as assessed via six minute walk test. (change in number of feet walked)', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month 6 minute walk data available are included.'}, {'type': 'SECONDARY', 'title': 'Serum BNP Levels in Patients With CHF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'title': 'BNP', 'categories': [{'measurements': [{'value': '63', 'spread': '249', 'groupId': 'OG000'}, {'value': '28', 'spread': '117', 'groupId': 'OG001'}]}]}, {'title': 'pro-BNP', 'categories': [{'measurements': [{'value': '234', 'spread': '1636', 'groupId': 'OG000'}, {'value': '497', 'spread': '1637', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.7', 'ciLowerLimit': '-150', 'ciUpperLimit': '80', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '176', 'groupDescription': 'Difference in the change in BNP(reg) between cell and placebo group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.', 'unitOfMeasure': 'IUs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month BNP data available are included.'}, {'type': 'SECONDARY', 'title': 'LV Diastolic Dimension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.5', 'spread': '34', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '-5.03', 'ciUpperLimit': '23.93', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '31.2', 'groupDescription': 'Change in the difference of end diastolic volume between the two groups over time.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month LV diastolic data available are included.'}, {'type': 'SECONDARY', 'title': 'Incidence of a Major Adverse Cardiac Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the incidence rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.133', 'ciUpperLimit': '0.039', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.044', 'groupDescription': 'The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).\n\n(Incidence rate)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Incidence of major adverse cardiac events between baseline and 6 months. (Incidence rate)'}, {'type': 'SECONDARY', 'title': 'Reduction in Fixed Perfusion Defect(s)Via SPECT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Injections', 'description': 'Participants received placebo injections.'}, {'id': 'OG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants received active stem cell injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '3.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.4', 'groupDescription': 'Difference in the change between the two groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Fixed total defect is the stress total defect minus the reversible component.', 'unitOfMeasure': 'percentage of defect that is fixed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with both baseline and six month fixed defect data available are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Injections', 'description': 'Participants will receive placebo injections.'}, {'id': 'FG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants will receive active stem cell injections.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment took place at five Network centers and their associated satellite facilities between April 29, 2009 and April 18, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Injections', 'description': 'Participants will receive placebo injections.'}, {'id': 'BG001', 'title': 'Active Stem Cell Injections', 'description': 'Participants will receive active stem cell injections.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.32', 'spread': '8.25', 'groupId': 'BG000'}, {'value': '63.95', 'spread': '10.90', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2009-01-15', 'resultsFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-22', 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximal Oxygen Consumption (VO2max)', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'The VO2(max) is assessed using the Naughton treadmill protocol.'}, {'measure': 'Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.'}, {'measure': 'Change in Reversible Defect Size', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.'}], 'secondaryOutcomes': [{'measure': 'Regional Wall Motion by MRI (in Eligible Patients)', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)'}, {'measure': 'Regional Blood Flow Improvement by MRI (in Eligible Patients)', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)'}, {'measure': 'Regional Wall Motion by Echocardiography', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Movement of the left ventricular wall measured in mm from baseline to six months.'}, {'measure': 'Clinical Improvement in CCS Classification (Angina Pectoris)', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)"able to conduct ordinary daily activity without causing angina" to Class IV (worst) "Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest." Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time.'}, {'measure': 'Clinical Improvement in NYHA Classification', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure". Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time.'}, {'measure': 'Number of Participants With a Decrease in Anti-anginal Medication', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)'}, {'measure': 'Exercise Time and Level', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Exercise time and level as assessed via six minute walk test. (change in number of feet walked)'}, {'measure': 'Serum BNP Levels in Patients With CHF', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.'}, {'measure': 'LV Diastolic Dimension', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography'}, {'measure': 'Incidence of a Major Adverse Cardiac Event', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).\n\n(Incidence rate)'}, {'measure': 'Reduction in Fixed Perfusion Defect(s)Via SPECT', 'timeFrame': 'Measured at Baseline and Month 6', 'description': 'Fixed total defect is the stress total defect minus the reversible component.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congestive Heart Failure', 'Regional Wall Motion', 'Perfusion Defects'], 'conditions': ['Chronic Ischemic Heart Disease', 'Left Ventricular Dysfunction', 'Angina', 'Ischemic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '20524773', 'type': 'BACKGROUND', 'citation': 'Gee AP, Richman S, Durett A, McKenna D, Traverse J, Henry T, Fisk D, Pepine C, Bloom J, Willerson J, Prater K, Zhao D, Koc JR, Ellis S, Taylor D, Cogle C, Moye L, Simari R, Skarlatos S. Multicenter cell processing for cardiovascular regenerative medicine applications: the Cardiovascular Cell Therapy Research Network (CCTRN) experience. Cytotherapy. 2010 Sep;12(5):684-91. doi: 10.3109/14653249.2010.487900.'}, {'pmid': '20691824', 'type': 'BACKGROUND', 'citation': 'Willerson JT, Perin EC, Ellis SG, Pepine CJ, Henry TD, Zhao DX, Lai D, Penn MS, Byrne BJ, Silva G, Gee A, Traverse JH, Hatzopoulos AK, Forder JR, Martin D, Kronenberg M, Taylor DA, Cogle CR, Baraniuk S, Westbrook L, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moye LA, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design. Am Heart J. 2010 Aug;160(2):215-23. doi: 10.1016/j.ahj.2010.03.029.'}, {'pmid': '22137069', 'type': 'BACKGROUND', 'citation': 'Zierold C, Carlson MA, Obodo UC, Wise E, Piazza VA, Meeks MW, Vojvodic RW, Baraniuk S, Henry TD, Gee AP, Ellis SG, Moye LA, Pepine CJ, Cogle CR, Taylor DA. Developing mechanistic insights into cardiovascular cell therapy: Cardiovascular Cell Therapy Research Network Biorepository Core Laboratory rationale. Am Heart J. 2011 Dec;162(6):973-80. doi: 10.1016/j.ahj.2011.05.024.'}, {'pmid': '22447880', 'type': 'RESULT', 'citation': 'Perin EC, Willerson JT, Pepine CJ, Henry TD, Ellis SG, Zhao DX, Silva GV, Lai D, Thomas JD, Kronenberg MW, Martin AD, Anderson RD, Traverse JH, Penn MS, Anwaruddin S, Hatzopoulos AK, Gee AP, Taylor DA, Cogle CR, Smith D, Westbrook L, Chen J, Handberg E, Olson RE, Geither C, Bowman S, Francescon J, Baraniuk S, Piller LB, Simpson LM, Loghin C, Aguilar D, Richman S, Zierold C, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moye LA, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure: the FOCUS-CCTRN trial. JAMA. 2012 Apr 25;307(16):1717-26. doi: 10.1001/jama.2012.418. Epub 2012 Mar 24.'}, {'pmid': '25136078', 'type': 'DERIVED', 'citation': 'Cogle CR, Wise E, Meacham AM, Zierold C, Traverse JH, Henry TD, Perin EC, Willerson JT, Ellis SG, Carlson M, Zhao DX, Bolli R, Cooke JP, Anwaruddin S, Bhatnagar A, da Graca Cabreira-Hansen M, Grant MB, Lai D, Moye L, Ebert RF, Olson RE, Sayre SL, Schulman IH, Bosse RC, Scott EW, Simari RD, Pepine CJ, Taylor DA; Cardiovascular Cell Therapy Research Network (CCTRN). Detailed analysis of bone marrow from patients with ischemic heart disease and left ventricular dysfunction: BM CD34, CD11b, and clonogenic capacity as biomarkers for clinical outcomes. Circ Res. 2014 Oct 24;115(10):867-74. doi: 10.1161/CIRCRESAHA.115.304353. Epub 2014 Aug 18.'}], 'seeAlsoLinks': [{'url': 'http://www.cctrn.org', 'label': 'Click here for more information on the Cardiovascular Cell Therapy Research Network'}, {'url': 'http://www.nhlbi.nih.gov', 'label': 'Click here for more information on the National Heart, Lung, and Blood Institute'}]}, 'descriptionModule': {'briefSummary': "Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells into the person's heart as a way of treating people with CAD and heart failure.", 'detailedDescription': 'Coronary artery disease (CAD), a disease in which blood vessels become clogged by a build-up of plaque, is the leading cause of heart failure, a condition in which the heart can no longer pump enough blood to the rest of the body. People with heart failure caused by CAD are said to have ischemic cardiomyopathy. Normal treatment for CAD involves coronary artery bypass grafting (in which a vein from another part of the body is grafted around an artery that has become blocked) or coronary angioplasty and stent placement (in which a blocked artery is opened and a small tube is placed to keep the artery open). However, some people with ischemic cardiomyopathy, such as those with substantial scar tissue on the heart wall or those with a particular heart structure, may not be eligible for these treatments. An alternative treatment being developed is therapeutic angiogenesis, which involves stimulating the growth of new blood vessels. Recent research has shown that withdrawing stem cells from bone marrow and implanting the cells into heart tissue may be an effective way to achieve therapeutic angiogenesis. This study will determine the safety and effectiveness of using stem cells to stimulate new blood vessel growth in the hearts of people with ischemic cardiomyopathy.\n\nParticipation in this study, including follow-up visits and phone calls, will last 60 months. Participants will first undergo 3 to 4 days of screening procedures that will include a physical examination, multiple lab tests, and a battery of tests on heart health. Next, participants will be randomized to receive either active stem cell injections or placebo injections. The injections and related procedures will be performed in a hospital and last approximately 72 hours. During this time, participants in both groups will first undergo a bone marrow aspiration procedure. Participants receiving active stem cells will also undergo NOGA electromechanical cardiac mapping, which involves inserting a monitoring device through a catheter and into the heart. Injections of stem cells will then be made to 15 damaged sites on the heart through a special catheter. Participants receiving placebo injections will receive 15 injections of an inactive, saline-based solution. After the injection procedures, all participants will undergo two echocardiograms, an electrocardiogram, blood tests, and overnight monitoring in a telemetry unit.\n\nAfter the hospital stay, all participants will attend five study visits that will occur 1 week and 1, 3, 6, and 12 months after the injection procedures. At all study visits, participants will undergo an electrocardiogram, lab tests, and a review of adverse health events. On all but the last study visit, participants will have cardiac markers assessed, and they will wear a 24-hour Holter monitor to track heart activity. At the last three visits, participants will also complete quality of life questionnaires. All participants will then receive four follow-up telephone calls that will occur 2, 3, 4, and 5 years after the injection procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years of age with significant coronary heart disease not amenable to revascularization.\n* Left ventricular dysfunction (LVEF) less than or equal to 45%, measured by echocardiogram; limiting angina (Class II to IV); and/or congestive heart failure (CHF), NYHA class II to III\n* Receiving maximal medical therapy, defined as a medical regimen that includes the maximal tolerated dose of at least two antiangina medications, such as beta-blockers, nitrates, or calcium-channel blockers\n* Presence of a defect, as identified by single photon emission computed tomography (SPECT) isotope protocol, or viability, as identified by NOGA electromechanical cardiac mapping system\n* Coronary artery disease not well suited to any other type of revascularization procedure in the target region of the ventricle, as determined by a cardiovascular surgeon and interventional cardiologist who are not investigators in the trial\n* Hemodynamic stability, as defined by systolic blood pressure of at least 80 mm Hg without intravenous pressors or support devices\n* Females of childbearing potential must be willing to use two forms of birth control for the duration of the study\n\nExclusion Criteria:\n\n* Atrial fibrillation or flutter without a pacemaker that guarantees a stable heart rate\n* Unstable angina\n* Left ventricular (LV) thrombus, as documented by echocardiography or LV angiography\n* A vascular anatomy that precludes cardiac catheterization\n* Severe valvular disease or mechanical aortic valve that precludes safe entry of the catheter into the left ventricle\n* Pregnant or lactating\n* Platelet count less than 100,000 per mm3\n* White blood cell count less than 2,000 per mm3\n* Revascularization within 30 days of consent\n* Transient ischemic attack or stroke within 60 days of study consent\n* Implantable cardioverter-defibrillator shock within 30 days of baseline consent, and within 30 days of randomization\n* Presence of ventricular tachycardia lasting 30 seconds or more on 24-hour Holter monitor or electrocardiogram (ECG) performed during screening period\n* Bleeding diathesis, defined as an international normalized ratio of at least 2.0 in the absence of warfarin therapy\n* A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins\n* Has a known history of HIV, has active hepatitis B or active hepatitis C\n* Any condition requiring immunosuppressive medication\n* High-risk acute coronary syndrome (ACS) or a myocardial infarction in the month prior to consent\n* A left ventricular wall thickness of \\<8 mm (by echocardiogram) of the infero-lateral wall at the target site for cell injection.\n* Inability to walk on a treadmill, except for class IV angina patients, who will be evaluated separately\n* Enrolled in an investigational device or drug study within the previous 30 days\n* Hepatic dysfunction, as defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal range prior to study entry\n* Chronic renal insufficiency, defined as a serum creatinine level greater than 2.5 mg/dL or requiring dialysis\n* Any other condition that in the judgment of the investigator would be a contraindication to enrollment or follow-up'}, 'identificationModule': {'nctId': 'NCT00824005', 'briefTitle': 'Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction', 'orgStudyIdInfo': {'id': '580'}, 'secondaryIdInfos': [{'id': 'U01HL087318', 'link': 'https://reporter.nih.gov/quickSearch/U01HL087318', 'type': 'NIH'}, {'id': '1 U01-HL-087318-01 (Project 3)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Injections', 'description': 'Participants will receive placebo injections.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Active Stem Cell Injections', 'description': 'Participants will receive active stem cell injections.', 'interventionNames': ['Biological: Adult stem cells']}], 'interventions': [{'name': 'Adult stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['Adult autologous stem cells', 'Bone marrow mononucleated cells'], 'description': 'Single procedure of intramyocardial electromechanical-guided injection of approximately 100 million bone marrow mononucleated cells (BM-MNCs), administered in 15 different injection sites', 'armGroupLabels': ['Active Stem Cell Injections']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Human serum albumin', 'HSA'], 'description': 'Single procedure of intramyocardial electromechanical-guided needle insertions and injection of 5% human serum albumin and saline in 15 different injection sites', 'armGroupLabels': ['Placebo Injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida-Department of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77225', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Robert Simari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiovascular Cell Therapy Research Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Cardiovascular Cell Therapy Research Network (CCTRN)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - School of Public Health', 'investigatorFullName': 'Dr Lemuel A Moye III', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}