Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-06 @ 7:04 AM
Study NCT ID:
NCT02751060
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Plasma Non-coding RNAs as Biomarkers in Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the plasma expression of miR-320a in coronary heart disease patients compared to control patients', 'timeFrame': 'up to 24 months'}], 'secondaryOutcomes': [{'measure': 'number of participants with cardiovascular causes of death', 'timeFrame': 'up to 24 months'}, {'measure': 'number of participants with non fatal myocardial infarction or stroke', 'timeFrame': 'up to 24 months'}, {'measure': 'number of participants with re-hospitalization due to cardiovascular causes', 'timeFrame': 'up to 24 months'}, {'measure': 'number of participants with all causes of mortality', 'timeFrame': 'up to 24 months'}, {'measure': 'number of participants with myocardial infarction re-exacerbation or re-hospitalization', 'timeFrame': 'up to 24 months'}]}, 'conditionsModule': {'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '4000 outpatients or hospitalized patients with coronary heart diseasewill be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older;\n2. the most recent symptoms of coronary heart disease within 7 days;\n3. meet one of the following conditions: A. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); B. serum cardiac biomarkers positive (TnT/I or creatine kinase peak greater than 99% of URL); C. Electrocardiogram changes of myocardial ischemia.\n\nExclusion Criteria:\n\n1. pregnant women or plan to;\n2. participate in any drug clinical trials within 3 months;\n3. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;\n4. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);\n5. previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);\n6. patients refused to comply with the requirements of this study to complete the research work;\n7. according to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons)."}, 'identificationModule': {'nctId': 'NCT02751060', 'briefTitle': 'Evaluation of Plasma Non-coding RNAs as Biomarkers in Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Evaluation of Plasma Non-coding RNAs (miRNA-320a) as Biomarkers of Diagnosis, Prognosis and Treatment Effects in Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'TJ-IRB20160305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with coronary heart disease symptoms', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['patients with coronary heart disease symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Dao Wen Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Dao Wen Wang', 'investigatorAffiliation': 'Tongji Hospital'}}}}