Effect of an Optimal Heart Team Protocol on Decision-making Stability
The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial
1 other identifier
interventional
84
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jan 2022
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2021
CompletedFirst Posted
Study publicly available on registry
September 9, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMarch 30, 2023
October 1, 2022
12 months
August 26, 2021
March 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall percent agreement
The proportion of patients who received unanimous decision recommendations from the heart team
through study completion, an average of 1 year
Secondary Outcomes (4)
Kappa value of heart team decision-making
through study completion, an average of 1 year
Inappropriate decision rate
through study completion, an average of 1 year
Compliance rate in real-world treatment
through study completion, an average of 1 year
Reproducibility of decision-making
At 1-month after first phase of heart team meeting
Study Arms (2)
optimal heart team group
EXPERIMENTALHeart 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.
conventional heart team group
NO INTERVENTIONHeart 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
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.
Eligibility Criteria
You may qualify if:
- Patients 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.
You may not qualify if:
- prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
- cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
- concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
- concomitant atrial fibrillation or severe arrhythmia
- Eligibility Criteria for specialists:
- Annual PCI volume ≥200
- Annual left main PCI volume ≥25
- Capable of chronic total occlusion(CTO) PCI
- Clinical researcher experience in coronary revascularization
- Proficient in clinical guidelines
- CABG total volume ≥200
- Proficient in both on-pump and off-pump CABG
- Clinical researcher experience in coronary revascularization
- Proficient in clinical guidelines
- \) Proficient in clinical guidelines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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.
PMID: 36456006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhe Zheng, MD,PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2021
First Posted
September 9, 2021
Study Start
January 4, 2022
Primary Completion
December 30, 2022
Study Completion
February 28, 2023
Last Updated
March 30, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share