Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01899196
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2013-07-02
Brief Title:
Epicardial Adipose Tissue And Coronary Risk In HIV-Infected Patients
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN HIV-INFECTED PATIENTS
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANRS EP 52
Brief Summary:
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 franckboccarasataphpfr
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 andor 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 Fishers exact test Continuous variables will be compared using the Students 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
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 franckboccarasataphpfr
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 andor 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 Fishers exact test Continuous variables will be compared using the Students 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None