Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-31 @ 1:01 PM
Study NCT ID:
NCT00841958
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocardial Stem Cells Approach Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1', 'timeFrame': '2007-2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '20560030', 'type': 'RESULT', 'citation': 'Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, Poveshenko O, Kliver E, Shirokova N, Karaskov A, Dib N. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. doi: 10.1007/s12265-009-9123-8. Epub 2009 Sep 24.'}], 'seeAlsoLinks': [{'url': 'http://www.meshalkin.ru/', 'label': 'State Research Institute of Circulation Pathology Official Site'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who are not of childbearing potential\n* Age 21-75 years.\n* Patients with CAD, NYHA and CCS angina III-IV functional class\n* LVEF less than 35% measured by echocardiography or SPECT within three months of study entry\n* Unsuitable for initial or repeated conventional revascularization (CABG or PCI)\n\nExclusion Criteria:\n\n* Failure to provide informed consent.\n* Plan for PCI or CABG.\n* Non-cardiac illness with a life expectancy of less than 3 year.\n* Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).\n* Previous heart, kidney, liver, or lung transplantation.\n* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.\n* Recent acute myocardial infarction (AMI) within 90 days of study entry\n* Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment\n* History of moderate to severe aortic stenosis or prosthetic aortic valve\n* Permanent atrial fibrillation\n* Thrombosis in LV, based on echocardiography data'}, 'identificationModule': {'nctId': 'NCT00841958', 'acronym': 'ESCAPE', 'briefTitle': 'Endocardial Stem Cells Approach Efficacy', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients', 'orgStudyIdInfo': {'id': 'SCVM-029'}, 'secondaryIdInfos': [{'id': 'RU002', 'type': 'OTHER', 'domain': 'State Research Institute of Circulation Pathology'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous bone marrow mononuclear stem cells or peripheral blood stem cells', 'type': 'PROCEDURE', 'description': 'Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%'}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Evgeny A Pokushalov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Research Institute of Circulation Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}