Prognosis of Acute Coronary Syndrome in HIV-infected Patients

HIV Infection Clinical Trial

Official title:

Prognosis After Acute Coronary Syndrome in HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139958
• Other study ID #: PACS
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: July 26, 2010
• Start date: November 2003
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: Saint Antoine University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• HIV Infection
• HIV Infections
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Cardiology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Saint Antoine University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-		36 months	No