MABAC: Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02375893

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.

Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Other: No intervention Other: Healthy subject

Detailed Description

Atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of death worldwide. The prevention of risk factors can reduce the development of cardiovascular diseases. The final goal of our study is to find new protective or new risk factors that can be modulated to reduce the incidence of cardiovascular events.

Gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic regulation. Some bile acids, especially the secondary bile acids, transformed from the primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules.

We want to compare the pool of bile acids and the composition of gut microbiota between the coronary patients and the healthy subjects to identify the potential protective or deleterious bacteria / bile acids.

All patients admitted for a scheduled coronary angiogram will be included, then divided into two groups: coronary or healthy, based on the presence or the absence of atheroma during the coronary angiogram.

Feces and blood samples, and clinical and biological data, will be collected during the patient's hospitalisation. No additional exam will be performed. The blood sample will be collected during the coronary angiogram or during a routine blood test.

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Official Title is in French: Microbiote, Acides Biliaires et Athérome Coronaire (MABAC)

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Coronary patients Feces, blood sample, clinical and biological data. Presence (1) of coronary disease defined as the presence of atheroma during the coronary angiogram	Other: No intervention Collecting blood and feces samples
Healthy subjects (2) Feces, blood sample, clinical and biological data. Absence (2) of atheroma during the coronary angiogram	Other: Healthy subject Collecting blood and feces samples

Arm

Intervention/Treatment

Coronary patients

Feces, blood sample, clinical and biological data. Presence (1) of coronary disease defined as the presence of atheroma during the coronary angiogram

Other: No intervention

Collecting blood and feces samples

Healthy subjects (2)

Feces, blood sample, clinical and biological data. Absence (2) of atheroma during the coronary angiogram

Other: Healthy subject

Collecting blood and feces samples

Outcome Measures

Primary Outcome Measures

Gut microbiota composition in coronary patients versus healthy subject [8 months]
Observational only

Secondary Outcome Measures

Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples [8 months]
Observational

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients admitted for a coronary angiogram

Exclusion Criteria:

Statins, hypolipemic drugs, corticoids, anti HIV drugs
Antibiotics adminisitration in the last 3 months
Past of cholecystectomy
Hepatic disorders
Acute coronary syndrome
No agreement, Insufficiency in comprehension
Non fasting for at least 8 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Department, Cochin Hospital	Paris		France	75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Denis Duboc, MD, PhD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT02375893

Other Study ID Numbers:

2014-A01643-44

First Posted:

Mar 3, 2015

Last Update Posted:

Dec 16, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris

Additional relevant MeSH terms:

Coronary Disease

Coronary Artery Disease

Study Results

No Results Posted as of Dec 16, 2015