Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00139958
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis of Acute Coronary Syndrome in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Lipids, CRP, glycemia, insulinemia'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-26', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the rate of Major Adverse Cardiac and Cerebrovascular Events between HIV+ and HIV- after a first episode of ACS after a 3-years follow up.', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute coronary syndrome', 'HIV infection', 'Prognosis', 'Coronary heart disease', 'Revascularization'], 'conditions': ['Coronary Heart Disease', 'HIV Infection']}, 'referencesModule': {'references': [{'pmid': '35535605', 'type': 'DERIVED', 'citation': 'Robert R, Cottin Y, Potard V, Mary-Krause M, Lang S, Teiger E, Collet JP, Chauvet-Droit M, Ederhy S, Soulat-Dufour L, Ancedy Y, Adavane-Scheuble S, Nhan P, Steg PG, Funck-Brentano C, Costagliola D, Cohen A, Boccara F; on behalf the PACS-HIV Investigators. Coronary Angiographic Features and Major Adverse Cardiac or Cerebrovascular Events in People Living With Human Immunodeficiency Virus Presenting With Acute Coronary Syndrome. Circ Cardiovasc Interv. 2022 Jun;15(6):e011945. doi: 10.1161/CIRCINTERVENTIONS.122.011945. Epub 2022 May 10. No abstract available.'}, {'pmid': '32844734', 'type': 'DERIVED', 'citation': 'Boccara F, Mary-Krause M, Potard V, Teiger E, Lang S, Hammoudi N, Chauvet M, Ederhy S, Dufour-Soulat L, Ancedy Y, Nhan P, Adavane S, Steg PG, Funck-Brentano C, Costagliola D, Cohen A; PACS-HIV (Prognosis of Acute Coronary Syndrome in HIV-Infected Patients) Investigators dagger. HIV Infection and Long-Term Residual Cardiovascular Risk After Acute Coronary Syndrome. J Am Heart Assoc. 2020 Sep;9(17):e017578. doi: 10.1161/JAHA.119.017578. Epub 2020 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up.', 'detailedDescription': 'Background: There have been many cases of myocardial infarction reported in HIV-infected young adults treated with HAART. Little is known to date, concerning the outcome and prognostic factors of patients with acute coronary syndrome and HIV-infection.\n\nMethods: Prospective cohort study to compare the evolution and prognosis between HIV and non-HIV patients with an ACS.\n\nDuration of the study: Two years for including patients. Three years of follow-up 100 HIV-patients with ACS and 200 non-HIV patients with ACS will be included in the study. All patients will be included in the study from 30 Intensive Care Unit of Cardiology departments in France.\n\nResults: To compare the incidence of total mortality, cardiovascular mortality (myocardial infarction, sudden death, cardiogenic shock, fatal stroke), morbidity (non fatal myocardial infarction, unstable angina, recurrence of ischemia, cardiac failure, non fatal stroke) and revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery) during a 3-year follow-up between HIV and non-HIV patients with ACS. Univariate and multivariate analysis of predictive factors for cardiovascular events will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PAtients with de novo acute coronary syndromes age \\> 18years old.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients \\> 18 year's old\n* Man or woman HIV-infected for HIV 1 with or without highly active antiretroviral therapy\n* Acute coronary syndromes (STEMI, NSTEMI and unstable angina)\n\nExclusion Criteria:\n\n* Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)"}, 'identificationModule': {'nctId': 'NCT00139958', 'briefTitle': 'Prognosis of Acute Coronary Syndrome in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saint Antoine University Hospital'}, 'officialTitle': 'Prognosis After Acute Coronary Syndrome in HIV-infected Patients', 'orgStudyIdInfo': {'id': 'PACS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}, {'label': '2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Cardiology department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Ariel Cohen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Saint Antoine University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Antoine University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'SAint Antoine University Hospital', 'oldOrganization': 'Assistance publique Hôpitaux de Paris'}}}}