- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139958
Prognosis of Acute Coronary Syndrome in HIV-infected Patients
Prognosis After Acute Coronary Syndrome in HIV-infected Patients
Study Overview
Status
Conditions
Detailed Description
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.
Methods: Prospective cohort study to compare the evolution and prognosis between HIV and non-HIV patients with an ACS.
Duration 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.
Results: 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75012
- Cardiology Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients > 18 year's old
- Man or woman HIV-infected for HIV 1 with or without highly active antiretroviral therapy
- Acute coronary syndromes (STEMI, NSTEMI and unstable angina)
Exclusion Criteria:
- Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
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2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: 36 months
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36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-
Time Frame: 36 months
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36 months
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Collaborators and Investigators
Investigators
- Study Chair: Ariel Cohen, MD, PhD, Saint Antoine University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Heart Diseases
- HIV Infections
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Acute Coronary Syndrome
Other Study ID Numbers
- PACS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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