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

This study is currently recruiting participants.
Verified July 2013 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 18, 2013
Last verified: July 2013

July 2, 2013
July 18, 2013
July 2013
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01899196 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Epicardial Adipose Tissue And Coronary Risk In HIV-Infected Patients
EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN HIV-INFECTED PATIENTS

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Hiv Infection
Biological: blood sampling,
no Arm
Intervention: Biological: blood sampling,
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2015
May 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Yes
Contact: Franck BOCCARA, Pr 01 49 28 24 49 franck.boccara@sat.aphp.fr
Contact: Sylvie Lang
France
 
NCT01899196
ANRS EP 52 PIECVIH
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Pascal LEPRINCE Hôpital La Pitié Salpétrière Paris
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

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