NCT02375893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

February 24, 2015

Last Update Submit

November 17, 2025

Conditions

Keywords

Coronary diseaseBile acidsGut microbiotaRisk factorsAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition in coronary patients versus healthy subject

    Observational only

    8 months

Secondary Outcomes (1)

  • Bile acids composition in coronary patients versus healthy subjects, in feces and blood samples

    8 months

Study Arms (2)

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

Healthy subjects (2)

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

Other: Healthy subject

Interventions

Collecting blood and feces samples

Coronary patients

Collecting blood and feces samples

Healthy subjects (2)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary care center: cardiology unit.

You may qualify if:

  • \- All patients admitted for a coronary angiogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Cochin Hospital

Paris, 75014, France

Location

Related Publications (1)

  • Chong Nguyen C, Duboc D, Rainteau D, Sokol H, Humbert L, Seksik P, Bellino A, Abdoul H, Bouazza N, Treluyer JM, Saadi M, Wahbi K, Soliman H, Coffin B, Bado A, Le Gall M, Varenne O, Duboc H. Circulating bile acids concentration is predictive of coronary artery disease in human. Sci Rep. 2021 Nov 22;11(1):22661. doi: 10.1038/s41598-021-02144-y.

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Denis Duboc, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations