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Prognosis of Acute Coronary Syndrome in HIV-infected Patients

This study has been completed.
Sponsor:
Information provided by:
Saint Antoine University Hospital
ClinicalTrials.gov Identifier:
NCT00139958
First received: August 29, 2005
Last updated: July 26, 2010
Last verified: May 2010
History of Changes

August 29, 2005
July 26, 2010
November 2003
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00139958 on ClinicalTrials.gov Archive Site
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV- [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Prognosis of Acute Coronary Syndrome in HIV-infected Patients
Prognosis After 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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Lipids, CRP, glycemia, insulinemia
Probability Sample

PAtients with de novo acute coronary syndromes age > 18years old.
  • Coronary Heart Disease
  • HIV Infection
Not Provided
  • 1
  • 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00139958
PACS
Yes
SAint Antoine University Hospital, Assistance publique Hôpitaux de Paris
Saint Antoine University Hospital
Not Provided
Study Chair: Ariel Cohen, MD, PhD Saint Antoine University Hospital
Saint Antoine University Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP