Prognosis of Acute Coronary Syndrome in HIV-infected Patients
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|ClinicalTrials.gov Identifier: NCT00139958|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : July 28, 2010
|Condition or disease|
|Coronary Heart Disease HIV Infection|
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 :||Observational|
|Actual Enrollment :||300 participants|
|Observational Model:||Case Control|
|Official Title:||Prognosis After Acute Coronary Syndrome in HIV-infected Patients|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
- 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 ]
- Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV- [ Time Frame: 36 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139958
|Paris, France, 75012|
|Study Chair:||Ariel Cohen, MD, PhD||Saint Antoine University Hospital|