Clinical trial NCT02405468: Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
Official title: Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Myocardial Infarction
Keywords: blood microbiota
coronary disease
myocardial infarction
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 202
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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

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


Eligibility criteria: Inclusion Criteria:

* Cases : 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:

1. Treated hypertension,
2. Treated dyslipidemia
3. Current smoking
4. Diabetes mellitus

Exclusion Criteria:

* Infectious disease within one week before the inclusion
* Immunocompromised patients
* Antibiotic treatment within one month before the inclusion
* Chronic viral infection
* Chronic inflammatory intestinal bowel disease
* Renal failure (estimated glomerular filtration rate\< 50 ml/min//1.73 m2)
* Pregnancy

Primary outcomes:
measure: blood bacterial 16s rDNA bacterial gene concentration
timeFrame: 12 months
Secondary outcomes:
measure: blood microbiota profile
timeFrame: 12 months
Other outcomes:
measure: lipid profile
timeFrame: 12 months
measure: functional HDL
timeFrame: 12 months
measure: microARN profile
timeFrame: 12 months
measure: Serum Bank and DNA Bank
timeFrame: 10 years
measure: modifications of the blood microbiota
timeFrame: 12 months
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Meyer Elbaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.