Prognosis of Acute Coronary Syndrome in HIV-infected Patients

Completed

• Conditions: Coronary Heart Disease; HIV Infection

• Registration Number: NCT00139958
• Lead Sponsor: Saint Antoine University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Status Verified: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-26
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	36 months

Secondary Outcome Measures

Name	Time	Method
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-	36 months

Trial Locations

Locations (1)

Cardiology department; 🇫🇷 Paris, France