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Prognosis of Acute Coronary Syndrome in HIV-Infected Patients
This study is currently recruiting participants.
Verified by Saint Antoine University Hospital, August 2005
Sponsored by: Saint Antoine University Hospital
Information provided by: Saint Antoine University Hospital
ClinicalTrials.gov Identifier: NCT00139958
  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 IV

MedlinePlus related topics: AIDS Coronary Artery Disease Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Case Control, Prospective Study
Official Title: Prognosis After Acute Coronary Syndrome in HIV-Infected Patients

Further study details as provided by Saint Antoine University Hospital:

Estimated Enrollment: 300
Study Start Date: November 2003
Estimated Study Completion Date: April 2009
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
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 Recruiting
Paris, France, 75012
Contact: Franck Boccara, MD     +33149282449     franck.boccara@sat.ap-hop-paris.fr    
Principal Investigator: Franck Boccara, MD            
Sponsors and Collaborators
Saint Antoine University Hospital
Investigators
Study Chair: Ariel Cohen, MD, PhD Saint Antoine University Hospital
  More Information

Study ID Numbers: PACS
Study First Received: August 29, 2005
Last Updated: August 29, 2005
ClinicalTrials.gov Identifier: NCT00139958  
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Sexually Transmitted Diseases, Viral
Heart Diseases
Myocardial Ischemia
Acquired Immunodeficiency Syndrome
Vascular Diseases
Arteriosclerosis
Ischemia
Immunologic Deficiency Syndromes
Coronary Disease
Virus Diseases
HIV Infections
Acute Coronary Syndrome
Sexually Transmitted Diseases
Retroviridae Infections
Coronary Artery Disease

Additional relevant MeSH terms:
RNA Virus Infections
Pathologic Processes
Disease
Slow Virus Diseases
Immune System Diseases
Syndrome
Lentivirus Infections
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009