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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optimal heart team group | Experimental | 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. |
|
| conventional heart team group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optimal heart team protocol | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall percent agreement | The proportion of patients who received unanimous decision recommendations from the heart team | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Kappa value of heart team decision-making | 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. | through study completion, an average of 1 year |
| Inappropriate decision rate |
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Eligibility Criteria for patients:
Inclusion Criteria:
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.
Exclusion Criteria:
Eligibility Criteria for specialists:
Inclusion Criteria for interventional cardiologists:
Inclusion Criteria for cardiac surgeons:
Inclusion Criteria for non-interventional cardiologists:
1) Proficient in clinical guidelines
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| Name | Affiliation | Role |
|---|---|---|
| Zhe Zheng, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36456006 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
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 |
| through study completion, an average of 1 year |
| Compliance rate in real-world treatment | Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team | through study completion, an average of 1 year |
| Reproducibility of decision-making | All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making. | At 1-month after first phase of heart team meeting |
| China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |