Prognosis of Acute Coronary Syndrome in HIV-infected Patients

Prognosis After Acute Coronary Syndrome in HIV-infected Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00139958

Enrollment

300

Registered

2005-08-31

Start date

2003-11-30

Completion date

2010-07-31

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, HIV Infection

Keywords

Acute coronary syndrome, HIV infection, Prognosis, Coronary heart disease, Revascularization

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Exclusion criteria

* Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-	36 months

Countries

France

Outcome results