Coronary DiseaseFLORINFNCT02405468
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
An observational study of Coronary Disease and Myocardial Infarction, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease, Myocardial Infarction
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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:
- Treated hypertension,
- Treated dyslipidemia
- Current smoking
- Diabetes mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.
- Conditions
- Coronary Disease, Myocardial Infarction
- Keywords
- blood microbiota, coronary disease, myocardial infarction
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
blood bacterial 16s rDNA bacterial gene concentration
compare blood bacterial 16s rDNA bacterial gene concentration
Measured: 12 months
Secondary outcomes (1)
blood microbiota profile
compare blood microbiota profile as assessed at all taxonomic levels of interest (genus, family, order, class, phylum)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meyer Elbaz, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405468
- Sponsor's protocol ID
- 12 387 02
- Other IDs
- 2013-A00337-38
- Acronym
- FLORINF
- Status last verified
- Feb 2016
- First submitted
- 27 Mar 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grazide MH, Ruidavets JB, Martinet W, Elbaz M, Vindis C. Association of Circulating Autophagy Proteins ATG5 and Beclin 1 with Acute Myocardial Infarction in a Case-Control Study. Cardiology. 2024;149(3):217-224. doi: 10.1159/000537816. Epub 2024 Mar 2.
PubMed 38432214Amar 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.
PubMed 31566105
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
- ClinicalTrials.gov ID
- NCT02405468
- Acronym / sponsor ID
- FLORINF / 12 387 02
- Conditions
- Coronary Disease, Myocardial Infarction
- Keywords
- blood microbiota, coronary disease, myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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:
- Treated hypertension,
- Treated dyslipidemia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood bacterial 16s rDNA bacterial gene concentration
Time frame: 12 months
compare blood bacterial 16s rDNA bacterial gene concentration
1 secondary outcome
blood microbiota profile
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 38432214Grazide MH, Ruidavets JB, Martinet W, Elbaz M, Vindis C. Association of Circulating Autophagy Proteins ATG5 and Beclin 1 with Acute Myocardial Infarction in a Case-Control Study. Cardiology. 2024;149(3):217-224. doi: 10.1159/000537816. Epub 2024 Mar 2.
- Derived from this study: PubMed 31566105Amar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meyer Elbaz, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Myocardial Infarction, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood bacterial 16s rDNA bacterial gene concentration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.