Epicardial Adipose Tissue And Coronary Risk In HIV-Infected Patients (ANRS EP 52)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01899196
First received: July 2, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Protocol date and version RCB Id : 2013-A00547-38

Etude ANRS EP 52 PIECVIH Title of Study: EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN HIV-INFECTED PATIENTS

Short title - PIECVIH study

Sponsor French National Institute for Health and Medical Research - French national agency for research on AIDS and viral hepatitis (Inserm-ANRS)

Coordinating Investigator Pr Franck BOCCARA Service de Cardiologie, Hôpital St Antoine INSERM UMRS 938 Paris, UPMC, Institut hospitalo-Universitaire- Institute of Cardiometabolism and Nutrition (IHU-ICAN) 184, rue du Faubourg Saint-Antoine 75571 PARIS Cedex 12 Tél. : 01 49 28 24 49 - Fax : 01 49 28 26 83 Courriel : franck.boccara@sat.aphp.fr

Participating country: France

Objectives Principal objective the inflammatory profile of the epicardial adipose (EAT) tissue between HIV-infected and uninfected patients undergoing cardiac surgery for coronary artery bypass graft (CABG)

Secondary objectives the volume of EAT between HIV-infected and uninfected patients undergoing cardiac surgery the relations between the adipocytokines and cytokines profile in the EAT and coronary artery lesions.

the relations between the adipocytokines and cytokines profile in the EAT and in the systemic circulation.

the histological and inflammatory profiles of the EAT and the subcutaneous adipose tissue of each patients.

Methodology multicentric, national, comparative study

Estimated enrolment 30 subjects (total and 15 per group) HIV-uninfected will be matched to HIV+ by age (± 5 years) and gender

  1. 15 HIV+ undergoing CABG
  2. 15 HIV- undergoing CABG

Outcomes Primary outcome:

• Inflammatory balance and profile (expression of adipocytokines, chemiokines and cytokines, and renin angiotensin system) in the EAT

Secondary outcomes :

  • Macroscopic profile of EAT (adipocytes, fibrosis, endothelial cells)
  • Secretome of EAT
  • Comparative inflammatory and macroscopic profile between EAT and subcutaneous adipose tissue

Eligibility Inclusion criteria

  • Men or women > 18 years old, HIV1 + for more than 6 months
  • Planned first cardiac surgery for CABG

Non-inclusion criteria History of cardiac surgery

Statistical methods Comparative analysis using parametric and non parametric tests

Estimated planning or Study / Trial timetable Study start date: May 2013 Enrolment period: 24 months Subject participation duration: 1 day Total study duration: 24 months Estimated study completion date: May 2015


Condition Intervention
Hiv Infection
Biological: blood sampling,

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN HIV-INFECTED PATIENTS

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • comparison of the inflammatory profile of the epicardial adipose (EAT) tissue between HIV-infected and uninfected patients undergoing cardiac surgery for coronary artery bypass graft (CABG) [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison the volume of EAT between HIV-infected and uninfected patients undergoing cardiac surgery [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Evaluation of the relations between the adipocytokines and cytokines profile in the EAT and in the systemic circulation. [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Comparison of the histological and inflammatory profiles of the EAT and the subcutaneous adipose tissue of each patients. [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Evaluation of the relations between the adipocytokines and cytokines profile in the EAT and coronary artery lesions. [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
no Arm Biological: blood sampling,

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

VIH + GROUP:

  • Men or women > 18 years old, HIV1 + for more than 6 months
  • Planned first cardiac surgery for CABG

VIH - GROUP:

  • Men or women > 18 years old,
  • Planned first cardiac surgery for CABG

Exclusion Criteria:

- History of cardiac surgery

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899196

Contacts
Contact: Franck BOCCARA, Pr 01 49 28 24 49 franck.boccara@sat.aphp.fr
Contact: Sylvie Lang

Locations
France
Hospital St Antoine Recruiting
Paris, France, 75012
Contact: Franck Boccara         
Principal Investigator: Franck Boccara         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Pascal LEPRINCE Hôpital La Pitié Salpétrière Paris
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01899196     History of Changes
Other Study ID Numbers: ANRS EP 52 PIECVIH
Study First Received: July 2, 2013
Last Updated: July 22, 2014
Health Authority: French: National Agency for Medicines and Health Products Safety

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Cardiac surgery

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency 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

ClinicalTrials.gov processed this record on August 26, 2014