NCT02405468

Brief Summary

The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Typical duration 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

July 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
8 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

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

March 27, 2015

Last Update Submit

February 14, 2016

Conditions

Coronary DiseaseMyocardial Infarction

Keywords

blood microbiotacoronary diseasemyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • blood bacterial 16s rDNA bacterial gene concentration

    compare blood bacterial 16s rDNA bacterial gene concentration

    12 months

Secondary Outcomes (1)

  • blood microbiota profile

    12 months

Other Outcomes (5)

  • lipid profile

    12 months

  • functional HDL

    12 months

  • microARN profile

    12 months

  • +2 more other outcomes

Study Arms (2)

case

patients with a myocardial infarction within one month to one year before the inclusion

control

patients without history of myocardial infarction, free of coronary disease in the view of one of the following test performed within one year before the inclusion : Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with \>= 2 major cardiovascular risk factors : * Treated hypertension * Treated dyslipidemia * Current smoking * Diabetes mellitus

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

case : patients who have had a myocardial infarction within one month to one year before the inclusion controls : patients without history of myocardial infarction, free of coronary disease in the view of one of the following tests performed within one year before the inclusion Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with \>= 2 major cardiovascular risk factors: * Treated hypertension, * Treated dyslipidemia * Current smoking * Diabetes mellitus

You may qualify if:

  • Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with \>= 2 major cardiovascular risk factors:
  • Treated hypertension,
  • Treated dyslipidemia
  • Current smoking
  • Diabetes mellitus

You may not qualify if:

  • Immunocompromised patients
  • Chronic viral infection
  • Chronic inflammatory intestinal bowel disease
  • Renal failure (estimated glomerular filtration rate\< 50 ml/min//1.73 m2)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

Related Publications (1)

  • Amar J, Lelouvier B, Servant F, Lluch J, Burcelin R, Bongard V, Elbaz M. Blood Microbiota Modification After Myocardial Infarction Depends Upon Low-Density Lipoprotein Cholesterol Levels. J Am Heart Assoc. 2019 Oct;8(19):e011797. doi: 10.1161/JAHA.118.011797. Epub 2019 Sep 28.

    PMID: 31566105DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Coronary DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Meyer Elbaz, PhD

    University Hospital, Toulouse

    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

March 27, 2015

First Posted

April 1, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)