Prognosis of Acute Coronary Syndrome in HIV-infected Patients

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.

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Key information

Conditions

Coronary Heart Disease Acute Coronary Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Coronary Disease Genital Diseases HIV Infection HIV Infections Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Myocardial Ischemia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology department

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-

Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Saint Antoine University Hospital

Other

Registry information

Official study title

Prognosis After Acute Coronary Syndrome in HIV-infected Patients

Important dates

Study start: 2003
Primary completion: 2010
Study completion: 2010
First posted: Aug 31, 2005
Registry last updated: Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed