Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 4:59 PM
Study NCT ID:
NCT02870933
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2016-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tricts2000@yahoo.com', 'phone': '+62215684093', 'title': 'Tri Wisesa Soetisna, M.D, MHA, PhD', 'organization': 'National Cardiovascular Center Harapan Kita'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Subject', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control', 'description': 'this arm will receive CABG only', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Myocardial Defect Perfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '15.76', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '15.38', 'spread': '4.87', 'groupId': 'OG001'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '2.08', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '5.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Number of heart wall segments with perfusion defect measured by MRI.', 'unitOfMeasure': 'Percentage of Myocardial Perfusion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '25.88', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '30.18', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '34.58', 'spread': '11.32', 'groupId': 'OG000'}, {'value': '31.62', 'spread': '7.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \\< 41%', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Six Minutes Walking Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000', 'lowerLimit': '260.50', 'upperLimit': '350.00'}, {'value': '298', 'groupId': 'OG001', 'lowerLimit': '255', 'upperLimit': '371'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '420', 'groupId': 'OG000', 'lowerLimit': '381', 'upperLimit': '441'}, {'value': '378', 'groupId': 'OG001', 'lowerLimit': '335', 'upperLimit': '414.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Quality of life will be assessed using Six minutes walking test, to see the changes of six minutes walking test before and after intervention Distances reported for healthy individuals ages 40 yo 85 years range from 400 to 700 m..', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wall Motion Score Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '2.32', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Cardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended.\n\nA WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Scar Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'subjectTransepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre op', 'categories': [{'measurements': [{'value': '27.76', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '24.45', 'spread': '13.73', 'groupId': 'OG001'}]}]}, {'title': 'Post op', 'categories': [{'measurements': [{'value': '25.46', 'spread': '12.91', 'groupId': 'OG000'}, {'value': '27.32', 'spread': '12.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Percentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used\n\n1. spatial (circumferential) extent, the number of affected segments\n2. nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4\n3. total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient)', 'unitOfMeasure': 'Percentage of Scar Area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Endothelial Growth Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '46.86', 'spread': '141.20', 'groupId': 'OG000'}, {'value': '40.46', 'spread': '40.08', 'groupId': 'OG001'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '61.05', 'spread': '63.01', 'groupId': 'OG000'}, {'value': '19.88', 'spread': '33.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricle End Systolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op LVESV', 'categories': [{'measurements': [{'value': '115.87', 'spread': '35.94', 'groupId': 'OG000'}, {'value': '141.05', 'spread': '7.77', 'groupId': 'OG001'}]}]}, {'title': 'Post-op LVESV', 'categories': [{'measurements': [{'value': '126.91', 'spread': '86.03', 'groupId': 'OG000'}, {'value': '149.33', 'spread': '44.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.\n\nNormal LVESV ranges is 37 - 57 mililiters.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minnesota Living With Heart Failure Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '39.5'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '26'}]}]}, {'title': 'Post-op', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '16'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Quality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention.\n\nMinimum score = 0, Maximum score = 105 Higher values represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricle End Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'OG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'classes': [{'title': 'Pre-op LVEDV', 'categories': [{'measurements': [{'value': '156.10', 'spread': '47.46', 'groupId': 'OG000'}, {'value': '200.89', 'spread': '37.10', 'groupId': 'OG001'}]}]}, {'title': 'Post-op LVEDV', 'categories': [{'measurements': [{'value': '183.68', 'spread': '94.99', 'groupId': 'OG000'}, {'value': '219.97', 'spread': '35.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.\n\nNormal ranges of LVEDV is 121 - 163 mililiters', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CABG + Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'FG001', 'title': 'Control', 'description': 'this arm will receive CABG only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CABG + Transepicardial With Transseptal CD 133+ Implantation', 'description': 'this arm will receive Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'BG001', 'title': 'Control', 'description': 'this arm will not receive Transepicardial with Transseptal CD 133+ Implantation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.92', 'spread': '8.95', 'groupId': 'BG000'}, {'value': '57.46', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '56.69', 'spread': '7.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Indonesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121.92', 'spread': '14.37', 'groupId': 'BG000'}, {'value': '126.5', 'spread': '19.60', 'groupId': 'BG001'}, {'value': '123.38', 'spread': '17.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Systolic blood pressure is created when the heart beats, squeezes and push blood through arteries. The unit of measure is mmHg.\n\nNormal range for systolic pressure is \\< 120 mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.00', 'spread': '12.03', 'groupId': 'BG000'}, {'value': '72.46', 'spread': '15.36', 'groupId': 'BG001'}, {'value': '75.04', 'spread': '13.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Pressure blood exerts within arteries between heart beats. Normal range for diastolic pressure is \\< 80 mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Smoking as one of coronary artery disease risk factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Dyslipidemia as one of coronary artery disease risk factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Hypertension as one of coronary artery disease risk factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Menopause', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Menopause as one of coronary artery disease risk factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Diabetes as one of coronary artery disease risk factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Random blood sugar level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '126.85', 'spread': '38.89', 'groupId': 'BG000'}, {'value': '136.85', 'spread': '39.0', 'groupId': 'BG001'}, {'value': '131.85', 'spread': '38.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The reference values for a "normal" random glucose test in an average adult are 80-140 mg/dl, between 140-2000 mg/dl is considered pre-diabetis, and \\>200 mg/dl is considered diabetes according ADA guidelines.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA grade III-IV', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NYHA (New York Heart Association) is classification for heart failure. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nClass II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nClass III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.', 'unitOfMeasure': 'Participants'}, {'title': 'CCS grade III-IV', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Canadian Cardiovascular Society grading of angina pectoris. I : Ordinary physical activity does not cause angina II: Slight limitation of ordinary activity III: Marked limitation of ordinary physical activity IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest', 'unitOfMeasure': 'Participants'}, {'title': 'Six minutes walk test', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '297.08', 'spread': '72.56', 'groupId': 'BG000'}, {'value': '308.92', 'spread': '79.37', 'groupId': 'BG001'}, {'value': '303.0', 'spread': '74.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '6-min walk test is sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricle Ejection Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.88', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '30.18', 'spread': '3.85', 'groupId': 'BG001'}, {'value': '28.03', 'spread': '5.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \\< 41%', 'unitOfMeasure': 'Percentage of Ejection Fraction', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricle End-Systolic Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '115.87', 'spread': '35.94', 'groupId': 'BG000'}, {'value': '141.05', 'spread': '27.77', 'groupId': 'BG001'}, {'value': '128.46', 'spread': '33.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Left ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.\n\nNormal LVESV ranges is 37 - 57 mililiters.', 'unitOfMeasure': 'mililiters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricle End-Diastolic Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '156.10', 'spread': '47.46', 'groupId': 'BG000'}, {'value': '200.89', 'spread': '37.10', 'groupId': 'BG001'}, {'value': '178.5', 'spread': '47.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Left ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.\n\nNormal ranges of LVEDV is 121 - 163 mililiters', 'unitOfMeasure': 'mililiters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Myocardial Scar Size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.76', 'spread': '15.76', 'groupId': 'BG000'}, {'value': '24.45', 'spread': '13.73', 'groupId': 'BG001'}, {'value': '26.11', 'spread': '14.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used\n\n1. spatial (circumferential) extent, the number of affected segments\n2. nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4\n3. total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient)', 'unitOfMeasure': 'Percentage of Scar Area', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Myocardial perfusion defect', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.76', 'spread': '4.38', 'groupId': 'BG000'}, {'value': '15.38', 'spread': '4.87', 'groupId': 'BG001'}, {'value': '15.57', 'spread': '4.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of heart wall segments with perfusion defect measured by MRI.', 'unitOfMeasure': 'Percentage of Myocardial Perfusion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wall motion score index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '0.17', 'groupId': 'BG000'}, {'value': '2.07', 'spread': '0.31', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '0.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended.\n\nA WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minnesotta Living with Heart Failure Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '13.73', 'groupId': 'BG000'}, {'value': '21.46', 'spread': '8.76', 'groupId': 'BG001'}, {'value': '25.88', 'spread': '12.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Quality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention.\n\nMinimum score = 0, Maximum score = 105 Higher values represent a worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vascular Endothelial Growth Factor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.86', 'spread': '141.20', 'groupId': 'BG000'}, {'value': '40.46', 'spread': '40.08', 'groupId': 'BG001'}, {'value': '43.66', 'spread': '101.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-25', 'size': 352480, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-25T06:30', 'hasProtocol': True}, {'date': '2020-02-25', 'size': 149810, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-25T06:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2016-08-07', 'resultsFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Defect Perfusion', 'timeFrame': 'Baseline, 6 months', 'description': 'Number of heart wall segments with perfusion defect measured by MRI.'}, {'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \\< 41%'}], 'secondaryOutcomes': [{'measure': 'Six Minutes Walking Test', 'timeFrame': 'Baseline, 6 months', 'description': 'Quality of life will be assessed using Six minutes walking test, to see the changes of six minutes walking test before and after intervention Distances reported for healthy individuals ages 40 yo 85 years range from 400 to 700 m..'}, {'measure': 'Wall Motion Score Index', 'timeFrame': 'Baseline, 6 months', 'description': 'Cardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended.\n\nA WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic.'}, {'measure': 'Myocardial Scar Size', 'timeFrame': 'Baseline, 6 months', 'description': 'Percentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used\n\n1. spatial (circumferential) extent, the number of affected segments\n2. nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4\n3. total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient)'}, {'measure': 'Vascular Endothelial Growth Factor', 'timeFrame': 'Baseline, 6 months', 'description': 'Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml'}, {'measure': 'Left Ventricle End Systolic Volume', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.\n\nNormal LVESV ranges is 37 - 57 mililiters.'}, {'measure': 'Minnesota Living With Heart Failure Questionnaire', 'timeFrame': 'Baseline, 6 months', 'description': 'Quality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention.\n\nMinimum score = 0, Maximum score = 105 Higher values represent a worse outcome'}, {'measure': 'Left Ventricle End Diastolic Volume', 'timeFrame': 'Baseline, 6 months', 'description': 'Left ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.\n\nNormal ranges of LVEDV is 121 - 163 mililiters'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CD 133+', 'Transepicardial with Transseptal Implantation', 'CABG'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Heart Failure has several etiologies and one of them is coronary artery disease. Coronary artery bypass grafting (CABG) is one of revascularizations method which has been used for decades in coronary artery disease theraphy. However, data about coronary artery bypass grafting shows that post-CABG patients still have low ejection fraction. For the last decade, there have been a lot of studies about the using of stem cells to increase heart contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells is given during CABG by injection transepicardial and transseptal. The purpose of this study is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem cells can improve myocardial perfusion in patient with low ejection fraction following CABG surgery.', 'detailedDescription': 'Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who fulfill inclusion and exclusion criteria\n\nSampling method : first we use consecutive method to find subject with male sex and age 40-70. After that, we use simple random sampling to allocate each subject to each group.\n\nTotal samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for each group.\n\nIntervention and measurement :\n\nControl group will only receive CABG surgery. Study group will receive CBAG surgery and stem cell implantation. Stem cell aspiration will be performed 1 day before CABG procedure. Before aspiration, patients will be given local anesthetic and light sedation. Stem cell will be collected from posterior iliac crest. Total aspirate 190 cc. Stem cell CD133+ will be separated using CliniMACS® Magnetic Separation Device after labelled with Magnetic microbeads - anti CD133 labelling.\n\nMyocardial perfusion reserve index will be measure using MRI. MPRI value will be obtained globally and segmentally in each 16 ventricle segments VEGF plasma level will be measured using sandwich Enzyme-linked Immunosorbent Assay method.\n\nEjection fraction, left ventricle dimension, and scar size will be measured using MRI.\n\nQuality of life will be measured using Minnesota Living With Heart Failure Questionnaire.\n\nStatistical analysis is done using IBM SPSS Statistics version 21.0 (SPSS inc, Chicago, IL, USA). Numerical data will be presented in either mean/standard deviation or median/min-max depend on distribution of data. Hypothesis test for numeric variable is done using paired/non-paired T test or Mann-Whitney/Wilcoxon depend on normality of data. Normality test is done using Shapiro-Wilk test. Hypothesis test for category varible is done using chi-square or fischer test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with coronary artery disease 3 vessels disease indicated for CABG\n* LVEF \\< 35% which has been confirmed by MRI\n* Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI\n* has signed informed consent\n\nExclusion Criteria:\n\nEmergency CABG Ungraftable coronary artery Acute myocardial Infarct (\\<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT \\> 1,5 upper normal value Creatinine \\> 2 g/dl. Malignancy\n\nDrop out criteria :\n\nAortic cross clamp \\>120 minutes and CABG total time \\>180'}, 'identificationModule': {'nctId': 'NCT02870933', 'briefTitle': 'Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}, 'officialTitle': 'The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'LB.02.01/VII/086/KEP.007.EV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subject', 'description': 'this arm will receive Transepicardial with Transseptal CD 133+ Implantation', 'interventionNames': ['Biological: Transepicardial with Transseptal CD 133+ Implantation']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'this arm will not receive Transepicardial with Transseptal CD 133+ Implantation'}], 'interventions': [{'name': 'Transepicardial with Transseptal CD 133+ Implantation', 'type': 'BIOLOGICAL', 'description': 'Transepicardial with Transseptal CD 133+ Implantation', 'armGroupLabels': ['subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11420', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'National Cardiovascular Center Harapan Kita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Tri Wisesa Soetisna, MD, MHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cardiovascular Center Harapan Kita'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cardiovascular Center Harapan Kita Hospital Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Human Capital and General Affairs of National Cardiac Center', 'investigatorFullName': 'Tri Wisesa Soetisna, MD, MHA', 'investigatorAffiliation': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}}}}