Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-29 @ 5:51 AM
Study NCT ID:
NCT02405468
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-14', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'lipid profile', 'timeFrame': '12 months', 'description': 'Obtain an accurate lipid profile with a new technic of microelectrophoresis(Lipoprint)'}, {'measure': 'functional HDL', 'timeFrame': '12 months', 'description': 'Analyse the functional qualities of the HDL from the serum'}, {'measure': 'microARN profile', 'timeFrame': '12 months', 'description': 'Search a microARN profile corresponding to the coronary heart disease'}, {'measure': 'Serum Bank and DNA Bank', 'timeFrame': '10 years', 'description': 'Form a Serum Bank and a DNA Bank for potential future analysis guided by microARN research'}, {'measure': 'modifications of the blood microbiota', 'timeFrame': '12 months', 'description': 'Analyse modification of the blood microbiota in the case and the control'}], 'primaryOutcomes': [{'measure': 'blood bacterial 16s rDNA bacterial gene concentration', 'timeFrame': '12 months', 'description': 'compare blood bacterial 16s rDNA bacterial gene concentration'}], 'secondaryOutcomes': [{'measure': 'blood microbiota profile', 'timeFrame': '12 months', 'description': 'compare blood microbiota profile as assessed at all taxonomic levels of interest (genus, family, order, class, phylum)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood microbiota', 'coronary disease', 'myocardial infarction'], 'conditions': ['Coronary Disease', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '31566105', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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:\n\n* Treated hypertension,\n* Treated dyslipidemia\n* Current smoking\n* Diabetes mellitus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cases : patients who have had a myocardial infarction within one month to one year before the inclusion\n* 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 :\n\nEffort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with \\>= 2 major cardiovascular risk factors:\n\n1. Treated hypertension,\n2. Treated dyslipidemia\n3. Current smoking\n4. Diabetes mellitus\n\nExclusion Criteria:\n\n* Infectious disease within one week before the inclusion\n* Immunocompromised patients\n* Antibiotic treatment within one month before the inclusion\n* Chronic viral infection\n* Chronic inflammatory intestinal bowel disease\n* Renal failure (estimated glomerular filtration rate\\< 50 ml/min//1.73 m2)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02405468', 'acronym': 'FLORINF', 'briefTitle': 'Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction', 'orgStudyIdInfo': {'id': '12 387 02'}, 'secondaryIdInfos': [{'id': '2013-A00337-38', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'case', 'description': 'patients with a myocardial infarction within one month to one year before the inclusion'}, {'label': 'control', 'description': '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 :\n\n* Treated hypertension\n* Treated dyslipidemia\n* Current smoking\n* Diabetes mellitus'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Meyer Elbaz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}