Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

Myocardial Infarction Clinical Trial

— FLORINF  

Official title:

Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405468
• Other study ID #: 12 387 02
• Secondary ID: 2013-A00337-38
• Status: Completed
• Phase: N/A
• First received: March 27, 2015
• Last updated: February 14, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lipid profile	Obtain an accurate lipid profile with a new technic of microelectrophoresis(Lipoprint)	12 months	No
Other	functional HDL	Analyse the functional qualities of the HDL from the serum	12 months	No
Other	microARN profile	Search a microARN profile corresponding to the coronary heart disease	12 months	No
Other	Serum Bank and DNA Bank	Form a Serum Bank and a DNA Bank for potential future analysis guided by microARN research	10 years	No
Other	modifications of the blood microbiota	Analyse modification of the blood microbiota in the case and the control	12 months	No
Primary	blood bacterial 16s rDNA bacterial gene concentration	compare blood bacterial 16s rDNA bacterial gene concentration	12 months	No
Secondary	blood microbiota profile	compare blood microbiota profile as assessed at all taxonomic levels of interest (genus, family, order, class, phylum)	12 months	No