Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-28 @ 3:09 AM
Study NCT ID:
NCT04554134
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hybrid Combination of CCTA and SPECT and CAG for Evaluation Prognosis of CAD: an Observational Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-11', 'releaseDate': '2022-08-11'}, {'releaseDate': '2023-07-13', 'unreleaseDate': '2023-07-14'}, {'resetDate': '2024-02-23', 'releaseDate': '2023-07-14'}], 'estimatedResultsFirstSubmitDate': '2022-08-11'}}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': '5 YEARS', 'description': 'All-cause death, cardiac death, ischemic stroke, unplanned revascularization and nonfatal myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SPECT', 'CCTA', 'CAG', 'Hybrid'], 'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'A total of 550 patients with stable angina (40-70% stenosis) tested by coronary CT angiography (CCTA) and single photon emission computed tomography (SPECT) and coronary angiography (CAG) within 3 months were retrospectively recruited from 2005 to 2015 and follow up to 5 years. A new hybrid software was used to analysis the image data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were suspected coronary artery disease and underwent CCTA, SPECT and CAG within 3 months from 2005 to 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-70\n2. Gender: All\n3. coronary artery disease patients (CAD)\n4. underwent CCTA, SPECT and coronary angiography (CAG) together within 3 months\n5. Time: 2005-2015\n\nExclusion Criteria:\n\n1. dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), congenital heart disease (CHD), atrial fibrillation (AF), ventricular tachycardia (VT)\n2. Prior coronary revascularization;\n3. permanent pacemaker or internal defibrillator\n4. prosthetic heart valve\n5. coronary image lose\n6. coronary artery severe calcification\n7. motion artifacts and poor CCTA image quality'}, 'identificationModule': {'nctId': 'NCT04554134', 'acronym': 'HSCA', 'briefTitle': 'The Hybrid Combination of CCTA and SPECT and CAG for Evaluation Prognosis of CAD: an Observational Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The First Affiliated Hospital of Nanjing Medical University', 'orgStudyIdInfo': {'id': '2019-SR-242'}, 'secondaryIdInfos': [{'id': 'BK20141020', 'type': 'OTHER_GRANT', 'domain': 'Zhihui Xu'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yi Chai, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The hybrid software will be uploaded to the open internet. Cardiologist could upload their patients' image data and the hybrid results will be proved."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Huai'an First People's Hospital", 'class': 'OTHER'}, {'name': "Changzhou No.2 People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xu Zhihui', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-11', 'type': 'RELEASE'}, {'date': '2023-07-11', 'type': 'RESET'}, {'date': '2023-07-13', 'type': 'RELEASE'}, {'date': '2023-07-14', 'type': 'UNRELEASE'}, {'date': '2023-07-14', 'type': 'RELEASE'}, {'date': '2024-02-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xu Zhihui, Director, The First Affiliated Hospital with Nanjing Medical University'}}}}