Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07054502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Validation of DL Model for Postoperative MACCE Prediction
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': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular and cerebrovascular events (MACCE)', 'timeFrame': 'within 30 days after surgery', 'description': 'Occurrence of MACCE within 30 days after surgery (composite outcome including myocardial infarction, stroke, coronary revascularization, heart failure, and death)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep learning', 'Non-cardiac surgery', 'Electrocardiogram', 'Multimodal', 'MACCE'], 'conditions': ['Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)']}, 'descriptionModule': {'briefSummary': 'This study aims to prospectively validate a deep learning model developed using retrospective data to predict major adverse cardiac and cerebrovascular events (MACCE) occurring within 30 days after non-cardiac surgery. The validation will be performed using prospectively collected data from patients undergoing non-cardiac surgery under general or regional anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-cardiac surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 or older undergoing non-cardiac surgery under general or regional anesthesia at Seoul National University Hospital\n\nExclusion Criteria:\n\n* Reoperation within 30 days after initial surgery\n* Organ procurement or pregnancy-related procedures\n* Ambulatory-based surgery\n* Preoperative tracheal intubation before entering the operating room\n* Surgeries performed outside the operating room'}, 'identificationModule': {'nctId': 'NCT07054502', 'briefTitle': 'Prospective Validation of DL Model for Postoperative MACCE Prediction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prospective Validation of Deep Learning Model to Predict Postoperative Major Adverse Cardiac and Cerebrovascular Event', 'orgStudyIdInfo': {'id': '2503-210-1630'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-cardiac surgical patients', 'description': 'Patient undergoing non-cardiac surgery under regional or general anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-Kyu Yoon', 'role': 'CONTACT', 'email': 'hyunkyu18@gmail.com', 'phone': '82-2-2072-2469'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyun-Kyu Yoon, MD', 'role': 'CONTACT', 'email': 'hyunkyu18@gmail.com', 'phone': '82-2-2072-1146'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Hyun-Kyu Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}