Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-09 @ 9:23 AM
Study NCT ID:
NCT03146494
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-07', 'studyFirstSubmitDate': '2017-05-07', 'studyFirstSubmitQcDate': '2017-05-07', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Role of Thyroid Function in the Development of STAAD.', 'timeFrame': '30 days', 'description': 'Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.'}, {'measure': 'The Role of Thyroid Function in the Prognosis of STAAD.', 'timeFrame': '30 days', 'description': 'Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stanford Type A Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\nThe main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.'}, 'identificationModule': {'nctId': 'NCT03146494', 'briefTitle': 'The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.', 'orgStudyIdInfo': {'id': 'Beijing Anzhen Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STAAD'}, {'label': 'Normal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjian Jiang, M.D.', 'role': 'CONTACT', 'email': 'jwj87427@126.com', 'phone': '+8618810252631'}], 'facility': 'Wenjian Jiang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wenjian Jiang, M.D.', 'role': 'CONTACT', 'email': 'jwj87427@126.com', 'phone': '+8618810252631'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}