Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:06 PM
Study NCT ID:
NCT06384703
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Microbiota and Coronary Ectasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A 3 ml blood sample was taken from the volunteer patients from the femoral artery and radial artery sheath entrance and kept at room temperature for 30 minutes. Then, it was centrifuged at 2500 r.p.m for 15 minutes to obtain a serum sample. The samples obtained within 6 months, which is the collection period of all patients, were stored in Eppendorf tubes at -80 degrees Celsius.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '1 month', 'description': 'Death from any cause within the last month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiota', 'endothelium'], 'conditions': ['Coronary Ectasia', 'Microbial Disease']}, 'descriptionModule': {'briefSummary': 'Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, patients with chronic stable angina who underwent coronary angiography were included after exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old\n* not having occlusive coronary artery disease\n* having coronary ectasia\n\nExclusion Criteria:\n\n* patients with chronic kidney disease,\n* revascularized coronary artery disease,\n* previously documented critical coronary stenosis,\n* acute or chronic inflammatory disease,\n* rheumatologic disease,\n* known active malignant disease,\n* heart failure,\n* moderate-to-severe valvular pathology\n* patients who were on any steroid or immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT06384703', 'briefTitle': 'The Relationship Between Microbiota and Coronary Ectasia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Konya Beyhekim Training and Research Hospital'}, 'officialTitle': 'The Evaluation of the Relationship Between Coronary Ectasia And Trimethylamine N Oxide', 'orgStudyIdInfo': {'id': '201518015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary ectasia cohort', 'description': 'Patients with coronary ectasia detected on coronary angiography and without any exclusion criteria were included.', 'interventionNames': ['Diagnostic Test: Taking blood for kit study']}, {'label': 'normal coronary cohort', 'description': 'Patients who underwent coronary angiography and did not have any of the exclusion criteria', 'interventionNames': ['Diagnostic Test: Taking blood for kit study']}], 'interventions': [{'name': 'Taking blood for kit study', 'type': 'DIAGNOSTIC_TEST', 'description': 'Taking blood for kit study (Elisa kit)', 'armGroupLabels': ['coronary ectasia cohort', 'normal coronary cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42050', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Yakup Alsancak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It was planned to share the trimethylamine N-oxide values obtained from the patients and the basic demographic data of the patients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Beyhekim Training and Research Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Necmettin Erbakan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}