Clinical trial NCT02375893: Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human
Official title: The Official Title is in French: Microbiote, Acides Biliaires et Athérome Coronaire (MABAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Coronary disease
Bile acids
Gut microbiota
Risk factors
Atherosclerosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care center: cardiology unit.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gut microbiota composition in coronary patients versus healthy subject
timeFrame: 8 months
Secondary outcomes:
measure: Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cardiology Department, Cochin Hospital
Study officials:
affiliation: APHP
name: Denis Duboc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: