Prognosis of Acute Coronary Syndrome in HIV-infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139958
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : July 28, 2010
Information provided by:
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.

Condition or disease
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 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 : November 2003
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV- [ Time Frame: 36 months ]

Biospecimen Retention:   Samples Without DNA
Lipids, CRP, glycemia, insulinemia

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PAtients with de novo acute coronary syndromes age > 18years old.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139958

Cardiology department
Paris, France, 75012
Sponsors and Collaborators
Saint Antoine University Hospital
Study Chair: Ariel Cohen, MD, PhD Saint Antoine University Hospital

Responsible Party: SAint Antoine University Hospital, Assistance publique Hôpitaux de Paris Identifier: NCT00139958     History of Changes
Other Study ID Numbers: PACS
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: May 2010

Keywords provided by Saint Antoine University Hospital:
Acute coronary syndrome
HIV infection
Coronary heart disease

Additional relevant MeSH terms:
HIV Infections
Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases