Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-06 @ 8:09 AM
Study NCT ID:
NCT03933358
Status:
UNKNOWN
Last Update Posted:
2019-05-03
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-04-29', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (major adverse cardiovascular events)', 'timeFrame': '12 months', 'description': 'cardiovascular death, re-infarction, revascularization, and stroke'}], 'secondaryOutcomes': [{'measure': 'adverse cardiac remodeling', 'timeFrame': '6 months', 'description': 'a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans'}, {'measure': 'all-cause death', 'timeFrame': '12 months', 'description': 'death caused by all reason'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid', 'Cardiac Remodeling, Ventricular', 'STEMI']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with STEMI receiving primary percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with a confirmed STEMI diagnosis\n* undergoing primary percutaneous coronary intervention (presenting \\<12h after symptom onset)\n* patients agreed and provided informed consent\n\nExclusion Criteria:\n\n* past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft\n* past history of heart failure (LVEF\\<40%) or myocardiopathy or atrial fibrillation\n* past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission\n* contraindicating to cardiac magnetic resonance imaging'}, 'identificationModule': {'nctId': 'NCT03933358', 'acronym': 'ThyREST', 'briefTitle': 'Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients', 'orgStudyIdInfo': {'id': 'BFH-Thyroid and STEMI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Euthyroid', 'interventionNames': ['Other: Thyroid hormone levels']}, {'label': 'Low T3', 'description': 'low triiodothyronine syndrome', 'interventionNames': ['Other: Thyroid hormone levels']}], 'interventions': [{'name': 'Thyroid hormone levels', 'type': 'OTHER', 'description': 'This is an observational study. Exposure: Different thyroid hormone levels.', 'armGroupLabels': ['Euthyroid', 'Low T3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Su', 'role': 'CONTACT', 'email': '15901120705@163.com'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongwei Li', 'role': 'CONTACT', 'email': 'lhw19656@sina.com', 'phone': '0086 10 63139780'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Hongwei Li, MD', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}