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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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: February 20, 2015
Last verified: February 2015
  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 To compare the inflammatory profile of the epicardial adipose tissue (EAT) between people living with and without HIVwho present with coronary heart disease and will undergo a coronary artery bypass graft (CABG)

Secondary objectives

  • To compare the volume of EAT between people living with and without HIV who present with coronary heart disease
  • To evaluate the relationship between the abnormalities of the expression profiles of the adipocytokines and cytokines with the atherosclerotic lesions.
  • To evaluate the relationship between the abnormalities of the expression profiles of the adipocytokines and cytokines of the EAT with the circulating levels and metabolic parameters.
  • To compare the histological and inflammatory profiles of the EAT with the subcutaneous adipose tissue for each patient individually.

Methodology multicentric, comparative study

Estimated enrollment 31 participants in total

  1. st group of- 15 people living with HIV undergoing CABG (coronary heart disease HIV+ group)
  2. nd group of- 16 people without HIV- undergoing CABG (coronary heart disease HIV- group) People without HIV-will be matched to people living with HIV+ by : age (± 5 years) and sex Outcomes

Primary outcome:

Comparative analysis of the inflammatory profile of the EAT : expression profile of the pro and anti inflammatory cytokines and adipokines within the EAT in both groups of participants : coronary heart disease HIV+ and HIV- groups

Secondary outcomes :

  • Determination of the EAT volume by echocardiography and cardiac scanner for both groups
  • Macroscopic profile of the EAT : adipocytes, fibrosis, endothelial cell density)
  • RT-PCR analyses : renin, adiponectine, PPARɣ
  • Comparatison of the inflammatory and macroscopic profiles between the EAT and the subcutaneous adipose tissue in the two groups by ARN messagers analysis.

Eligibility Inclusion criteria HIV+ group

  • Men or women above the age of 18 years old, HIV1 seropositive for more than 6 months
  • Individual undergoing, for the first time, cardiac surgery for CABG
  • Affiliated with a social security regimen (the AME is not a social security regimen)
  • Signed the consent form

HIV- group

  • Men or women above the age of 18 years old, HIV seronegative
  • Individuals undergoing, for the first time, cardiac surgery for CABG
  • Affiliated with a social security regimen (the AME is not a social security regimen)
  • Signed the consent form

Non-inclusion criteria History of surgery for CBAG and/or congenital heart defect- being under the tutorship or guardianship of the state or in custody of the justice system.

Statistical methods Categorical variables will be compared using Fisher's exact test. Continuous variables will be compared using the Student's t-test (parametric) and the Wilcoxon-Mann-Whitney test (non-parametric) as appropriate considering the data distribution. (statistical analysis software STATA 11 (StataCorp, Texas, USA))

Provisional study planning and timetable Study start date: July 2013 Enrollment period: 32 months Subject participation duration: 24 hours Total study duration: 32 months Estimated study completion date: end of March 2016


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: March 2016
Estimated Primary Completion Date: March 2016 (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: February 20, 2015
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

ClinicalTrials.gov processed this record on May 04, 2015