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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
Methodology multicentric, comparative study
Estimated enrollment 31 participants in total
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 :
Eligibility Inclusion criteria HIV+ group
HIV- group
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
VIH + GROUP:
VIH - GROUP:
Exclusion criteria
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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