Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT01633359
Status:
UNKNOWN
Last Update Posted:
2012-07-06
First Post:
2012-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-04', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of peripheral blood VSELs', 'timeFrame': 'during 1 year after enrollment', 'description': 'All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': 'During 1 year in the study period', 'description': 'All subject will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19118716', 'type': 'BACKGROUND', 'citation': 'Wojakowski W, Tendera M, Kucia M, Zuba-Surma E, Paczkowska E, Ciosek J, Halasa M, Krol M, Kazmierski M, Buszman P, Ochala A, Ratajczak J, Machalinski B, Ratajczak MZ. Mobilization of bone marrow-derived Oct-4+ SSEA-4+ very small embryonic-like stem cells in patients with acute myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):1-9. doi: 10.1016/j.jacc.2008.09.029.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients.', 'detailedDescription': '1. Hypothesis: The VSELs might be mobilized in the situation of cardiac ischemia in CAD patients. In addition, the benefits derived from Atorvastatin administration in CAD patients may be related to VSELs via sCD40L-SDF1/CXCR4 signal pathway.\n2. The number and function of peripheral blood VSELs in CAD patients compared with the controls.\n\n 1. Included patients: including 200 CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.\n 2. The IRB approve and all subjects sign the informed consent.\n 3. All subjects will receive the detection and analysis of the peripheral blood VSELs, including VSEL number, immigration capability after sCD40L administration.\n 4. All subjects will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.\n 5. the association between VSELs and MACE in CAD patients will be statistically analyzed.\n3. Atorvastatin administration improves the prognosis of CAD patients through exerting impacts on VSELs\n\n 1. Included patients: including 200 CAD patients receiving coronary angiography as positive subjects, 100 as control who are negative for coronary angiography.\n 2. The IRB approve and all subjects sign the informed consent.\n 3. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.\n 4. All subject will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.\n 5. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.\n 6. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.\n\nExclusion Criteria:\n\n* Infectious diseases, immunologically mediated disease, serious liver diseases, serious kidney diseases, malignant tumor, thrombocytopenia, pregnancy, occluded peripheral arterial diseases, bleeding or blood transfusion in the latest 2 months'}, 'identificationModule': {'nctId': 'NCT01633359', 'acronym': 'VSEL-CAD', 'briefTitle': 'The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'The Randomly Controlled Clinical Trial of the Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients', 'orgStudyIdInfo': {'id': 'TRAVEL-CAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive statin', 'description': '1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.\n2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.\n3. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.', 'interventionNames': ['Drug: Intensive statin']}, {'type': 'EXPERIMENTAL', 'label': 'Routine statin', 'description': '1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.\n2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.\n3. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.', 'interventionNames': ['Drug: Routine statin']}], 'interventions': [{'name': 'Intensive statin', 'type': 'DRUG', 'otherNames': ['Intensive Atorvastatin'], 'description': 'the Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period.', 'armGroupLabels': ['Intensive statin']}, {'name': 'Routine statin', 'type': 'DRUG', 'otherNames': ['Routine Atorvastatin.'], 'description': 'the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.', 'armGroupLabels': ['Routine statin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Ji Huang, MD', 'role': 'CONTACT', 'email': 'salyherry@163.com', 'phone': '86-10-64456535'}, {'name': 'Ji Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ji Huang, MD', 'role': 'CONTACT', 'email': 'salyherry@163.com', 'phone': '86-10-64456535'}], 'overallOfficials': [{'name': 'Hai-Yan Qian, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ji Huang', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician of Cardiology', 'investigatorFullName': 'Ji Huang', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}