Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction (FLORINF)

February 14, 2016 updated by: University Hospital, Toulouse
The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood bacterial 16s rDNA bacterial gene concentration
Time Frame: 12 months
compare blood bacterial 16s rDNA bacterial gene concentration
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood microbiota profile
Time Frame: 12 months
compare blood microbiota profile as assessed at all taxonomic levels of interest (genus, family, order, class, phylum)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid profile
Time Frame: 12 months
Obtain an accurate lipid profile with a new technic of microelectrophoresis(Lipoprint)
12 months
functional HDL
Time Frame: 12 months
Analyse the functional qualities of the HDL from the serum
12 months
microARN profile
Time Frame: 12 months
Search a microARN profile corresponding to the coronary heart disease
12 months
Serum Bank and DNA Bank
Time Frame: 10 years
Form a Serum Bank and a DNA Bank for potential future analysis guided by microARN research
10 years
modifications of the blood microbiota
Time Frame: 12 months
Analyse modification of the blood microbiota in the case and the control
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Meyer Elbaz, PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 387 02
  • 2013-A00337-38 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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