Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
Primary Purpose
Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heart team meeting and discussion
Sponsored by
About this trial
This is an interventional other trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- unprotected left main CAD(stenosis ≥70%);
- multi-vessel lesions (stenosis ≥70%);
- CAD whereby the referring interventional cardiologist considering refer to heart team discussion for technical and risk considerations
Exclusion Criteria:
- under the age of 18;
- previous history of PCI or CABG;
- admission for acute myocardial infarction, ECG and biomarker detection indicated acute phase;
- complicated with any comorbidity requiring surgical treatment, such as severe valvular heart disease, macrovascular disease, giant ventricular aneurysm, etc.;
- complicated with atrial fibrillation or severe arrhythmia;
- patients who are not suitable to wait for elective revascularization due to emergency conditions;
- refusal or rejection of a certain revascularization method (PCI or CABG);
- declined to participate in the study
Sites / Locations
- China National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
real-time heart team group
conventional heart team group
Arm Description
Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process
Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process
Outcomes
Primary Outcome Measures
1-year major adverse cardiovascular and cerebrovascular events
a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.
Secondary Outcome Measures
time interval between the completion of coronary angiography and the final treatment
time interval is considered as a key secondary outcome
the appropriateness rate of heart team decisions
assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines
heart team decision distribution
assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment
working load of organizing heart team meetings
to assess the work load of arganising heart team meetings by NASA-TLX
success rate of heart team organization
to assess the successful-connection with cardiac surgeons during or after the coronary angiography
time consuming of heart team discussions
to assess the time consuming of heart team organization and discussion during or after the coronary angiography
length of stay
to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital
total cost
to assess the total cost in hospital for the initial hospitalization and rehospitalization
time interval of each diagnosis and treatment procedures
to assess the time consuming of the angiography to heart team meeting time and heart team meeting to final treatment time
individual clinical adverse events
including all-cause death, cardiac death, myocardial infarction, stroke, revascularization of target vessels or transplanted vessels, revascularization for any reason, be admitted to hospital with angina again, readmission for cardiac reasons and readmission for any reason
Full Information
NCT ID
NCT05514210
First Posted
August 22, 2022
Last Updated
June 5, 2023
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05514210
Brief Title
Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
Official Title
Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.
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 conventional 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 efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
490 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real-time heart team group
Arm Type
Experimental
Arm Description
Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process
Arm Title
conventional heart team group
Arm Type
Active Comparator
Arm Description
Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process
Intervention Type
Behavioral
Intervention Name(s)
heart team meeting and discussion
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year major adverse cardiovascular and cerebrovascular events
Description
a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.
Time Frame
At 1 year after the coronary angiography
Secondary Outcome Measure Information:
Title
time interval between the completion of coronary angiography and the final treatment
Description
time interval is considered as a key secondary outcome
Time Frame
through study completion, an average of 1 year
Title
the appropriateness rate of heart team decisions
Description
assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines
Time Frame
through study completion, an average of 1 year
Title
heart team decision distribution
Description
assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment
Time Frame
through study completion, an average of 1 year
Title
working load of organizing heart team meetings
Description
to assess the work load of arganising heart team meetings by NASA-TLX
Time Frame
through study completion, an average of 1 year
Title
success rate of heart team organization
Description
to assess the successful-connection with cardiac surgeons during or after the coronary angiography
Time Frame
through study completion, an average of 1 year
Title
time consuming of heart team discussions
Description
to assess the time consuming of heart team organization and discussion during or after the coronary angiography
Time Frame
through study completion, an average of 1 year
Title
length of stay
Description
to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital
Time Frame
through study completion, an average of 1 year
Title
total cost
Description
to assess the total cost in hospital for the initial hospitalization and rehospitalization
Time Frame
through study completion, an average of 3 year
Title
time interval of each diagnosis and treatment procedures
Description
to assess the time consuming of the angiography to heart team meeting time and heart team meeting to final treatment time
Time Frame
through study completion, an average of 1 year
Title
individual clinical adverse events
Description
including all-cause death, cardiac death, myocardial infarction, stroke, revascularization of target vessels or transplanted vessels, revascularization for any reason, be admitted to hospital with angina again, readmission for cardiac reasons and readmission for any reason
Time Frame
At 1 year after the coronary angiography
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.]
At least 1 significant stenosis in all 3 major epicardial territories supplying viable myocardium;
Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.
Exclusion Criteria:
Less than 18 years of age;
Previous history of PCI or CABG;
Admitted for AMI, ECG and biomarker detection indicated acute stage;
Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
Combined with AF or severe arrhythmia;
Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;
Rejection or exclusion of a revascularization mode (PCI or CABG);
Refuse to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zheng, MD,PhD
Phone
+86-010-88396051
Email
zhengzhe@fuwai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanping Ma, MD
Phone
+86-010-88398027
Email
mahp_michelle@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
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