Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT06598995
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054084', 'term': 'Myocardial Bridging'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D003330', 'term': 'Coronary Vessel Anomalies'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 968}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'One month after discharge', 'description': 'Any death occurred one month after discharge'}], 'secondaryOutcomes': [{'measure': 'New-onset AF', 'timeFrame': 'One month after discharge.', 'description': 'Patients did not have AF before surgery, and AF occurred one month after discharge.'}, {'measure': 'Composite endpoints', 'timeFrame': 'One month after discharge', 'description': 'Composite endpoints including all-cause death, new-onset AF, and readmission due to heart failure, stroke, and other cardiovascular events (such as myocardial infarction, arrhythmia).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Bridging', 'Obstructive Hypertrophic Cardiomyopathy', 'Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': "This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:I(i) age ≥ 18 years and (ii) diagnosis of oHCM based on clinical and echocardiographic evaluation.\n\n\\-\n\nExclusion Criteria: (i) a history of heart surgery (ii) Patients who had coronary atherosclerosis or myocardial infraction; (iii) Patients who had no angiography records.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06598995', 'acronym': 'MB in oHCM', 'briefTitle': 'Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'The Association Between Myocardial Bridging and Atrial Fibrillation in Patients With Obstructive Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': '2022-1892'}, 'secondaryIdInfos': [{'id': '2022-GSP-GG-29', 'type': 'OTHER_GRANT', 'domain': 'National High Level Hospital Clinical Research Funding'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obstructive hypertrophic cardiomyopathy who underwent septal myectomy', 'description': 'All patients underwent angiography and without other coronary artery disease.', 'interventionNames': ['Procedure: Coronary artery bypass grafting or unroofing']}], 'interventions': [{'name': 'Coronary artery bypass grafting or unroofing', 'type': 'PROCEDURE', 'description': 'Patients had an MB with \\>75% compression degree would receive coronary artery bypass grafting, and those who underwent unroofing may had a depth of MB \\< 5mm (whether deal with these MB with a depth \\<5mm depends on the surgeon and the period time of patients received a surgery).', 'armGroupLabels': ['Obstructive hypertrophic cardiomyopathy who underwent septal myectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '475', 'city': 'Beijing', 'state': 'Please Select', 'country': 'China', 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Changrong Nie', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}