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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
  Purpose

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 Phase
Coronary Heart Disease
HIV Infection
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prognosis After Acute Coronary Syndrome in HIV-infected Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint Antoine University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV- [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Lipids, CRP, glycemia, insulinemia


Enrollment: 300
Study Start Date: November 2003
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

PAtients with de novo acute coronary syndromes age > 18years old.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139958

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

No publications provided

Responsible Party: SAint Antoine University Hospital, Assistance publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00139958     History of Changes
Other Study ID Numbers: PACS
Study First Received: August 29, 2005
Last Updated: July 26, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013