Prognosis of Acute Coronary Syndrome in HIV-infected Patients

Sponsor

Saint Antoine University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00139958

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease HIV Infection

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Prognosis After Acute Coronary Syndrome in HIV-infected Patients

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1
2

Outcome Measures

Primary Outcome Measures

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

Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV- [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)