Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-01 @ 10:42 PM
Study NCT ID:
NCT05039567
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Optimal Heart Team Protocol on Decision-making Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall percent agreement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The proportion of patients who received unanimous decision recommendations from the heart team'}], 'secondaryOutcomes': [{'measure': 'Kappa value of heart team decision-making', 'timeFrame': 'through study completion, an average of 1 year', 'description': "Fliess's (more than 2 raters) and Cohen's (2 raters) kappa coefficients to evaluate inter-team, inter-specialist, and inter-round agreement for treatment decisions."}, {'measure': 'Inappropriate decision rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'According to the American College of Cardiology/American Association for Thoracic Surgery/American Heart Association 2017 Appropriate Use Criteria for coronary revascularization, the inappropriate decision rate od decision-making'}, {'measure': 'Compliance rate in real-world treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': "Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team"}, {'measure': 'Reproducibility of decision-making', 'timeFrame': 'At 1-month after first phase of heart team meeting', 'description': 'All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Team protocol', 'Coronary Artery Disease', 'decision-making agreement'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '36456006', 'type': 'DERIVED', 'citation': 'Ma H, Lin S, Li X, Wang Y, Xu B, Zheng Z. Effect of a standardised heart team protocol versus a guideline-based protocol on revascularisation decision stability in stable complex coronary artery disease: rationale and design of a randomised trial of cardiology specialists using historic cases. BMJ Open. 2022 Dec 1;12(12):e064761. doi: 10.1136/bmjopen-2022-064761.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.', 'detailedDescription': 'Current guidelines recommend a heart team in the decision making for patients with complex coronary artery disease (CAD). Previous study reported that the agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in several aspects and a detailed heart team implementation protocol was generated and further validation is needed. This study is designed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria for patients:\n\nInclusion Criteria:\n\nPatients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease.\n\nExclusion Criteria:\n\n1. prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);\n2. cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;\n3. concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;\n4. concomitant atrial fibrillation or severe arrhythmia\n\nEligibility Criteria for specialists:\n\nInclusion Criteria for interventional cardiologists:\n\n1. Annual PCI volume ≥200\n2. Annual left main PCI volume ≥25\n3. Capable of chronic total occlusion(CTO) PCI\n4. Clinical researcher experience in coronary revascularization\n5. Proficient in clinical guidelines\n\nInclusion Criteria for cardiac surgeons:\n\n1. CABG total volume ≥200\n2. Proficient in both on-pump and off-pump CABG\n3. Clinical researcher experience in coronary revascularization\n4. Proficient in clinical guidelines\n\nInclusion Criteria for non-interventional cardiologists:\n\n1\\) Proficient in clinical guidelines'}, 'identificationModule': {'nctId': 'NCT05039567', 'briefTitle': 'Effect of an Optimal Heart Team Protocol on Decision-making Stability', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-1303-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'optimal heart team group', 'description': 'Heart teams in this group will be established according to the optimal heart team protocol. Each team consists of two interventional cardiologists and two cardiac surgeons. Team members will be trained systematically before the heart team meeting.', 'interventionNames': ['Behavioral: optimal heart team protocol']}, {'type': 'NO_INTERVENTION', 'label': 'conventional heart team group', 'description': 'Heart teams in this group will be established according to the basic elements recommended by guidelines. Each team consists of an interventional cardiologist, a cardiac surgeon, and a non-interventional cardiologist. No team training will be held before the heart team meeting.'}], 'interventions': [{'name': 'optimal heart team protocol', 'type': 'BEHAVIORAL', 'description': 'Heart teams in the experimental group will be established and trained based on the optimal heart team implementation protocol. The protocol included instructions on specialist selection, specialist training, team composition, team training and formal implementation precess.', 'armGroupLabels': ['optimal heart team group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhe Zheng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}