Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
Study Details
Study Description
Brief Summary
This study is aimed to evaluate the feasibility and clinical outcomes of the real-time heart team approach and the conventional heart team approach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the traditional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. Patients who are not randomized will be registered. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the feasibility and differences in clinical outcomes of patients under different heart team approaches.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: real-time heart team group Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process |
Behavioral: heart team meeting and discussion
When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.
|
| Active Comparator: conventional heart team group Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process |
Behavioral: heart team meeting and discussion
When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.
|
Outcome Measures
Primary Outcome Measures
- 1-year major adverse cardiovascular and cerebrovascular events [At 1 year after the coronary angiography]
a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.
Secondary Outcome Measures
- time consuming between the completion of coronary angiography and the final treatment [through study completion, an average of 1 year]
time consuming is considered as an key secondary outcome
- the appropriateness rate of heart team decisions [through study completion, an average of 1 year]
assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines
- heart team decision distribution [through study completion, an average of 1 year]
assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment
- working load of organizing heart team meetings [through study completion, an average of 1 year]
to assess the work load of arganising heart team meetings by NASA-TLX
- success rate of heart team organization [through study completion, an average of 1 year]
to assess the successful-connection with cardiac surgeons during or after the coronary angiography
- time consuming of heart team discussions [through study completion, an average of 1 year]
to assess the time consuming of heart team organization and discussion during or after the coronary angiography
- length of stay [through study completion, an average of 1 year]
to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital
- total cost [through study completion, an average of 3 year]
to assess the total cost in hospital for the initial hospitalization and rehospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
-
unprotected left main CAD(stenosis ≥70%);
-
multi-vessel lesions (stenosis ≥70%);
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CAD whereby the referring interventional cardiologist considering refer to heart team discussion for technical and risk considerations
Exclusion Criteria:
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under the age of 18;
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previous history of PCI or CABG;
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admission for acute myocardial infarction, ECG and biomarker detection indicated acute phase;
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complicated with any comorbidity requiring surgical treatment, such as severe valvular heart disease, macrovascular disease, giant ventricular aneurysm, etc.;
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complicated with atrial fibrillation or severe arrhythmia;
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patients who are not suitable to wait for elective revascularization due to emergency conditions;
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refusal or rejection of a certain revascularization method (PCI or CABG);
-
declined to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China National Center for Cardiovascular Diseases | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
- Principal Investigator: Zhe Zheng, MD,PhD, Fuwai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-1749