Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD

Coronary Artery Disease Clinical Trial

Official title:

Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05514210
• Other study ID #: 2022-1749
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD,PhD
• Phone: +86-010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 490
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. 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.]

2. At least 1 significant stenosis in all 3 major epicardial territories supplying viable myocardium;

3. Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.

Exclusion Criteria:

1. Less than 18 years of age;

2. Previous history of PCI or CABG;

3. Admitted for AMI, ECG and biomarker detection indicated acute stage;

4. Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;

5. Combined with AF or severe arrhythmia;

6. Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;

7. Rejection or exclusion of a revascularization mode (PCI or CABG);

8. Refuse to participate in the study.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Multidisciplinary Communication
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year major adverse cardiovascular and cerebrovascular events	a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.	At 1 year after the coronary angiography
Secondary	time interval between the completion of coronary angiography and the final treatment	time interval is considered as a key secondary outcome	through study completion, an average of 1 year
Secondary	the appropriateness rate of heart team decisions	assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines	through study completion, an average of 1 year
Secondary	heart team decision distribution	assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment	through study completion, an average of 1 year
Secondary	working load of organizing heart team meetings	to assess the work load of arganising heart team meetings by NASA-TLX	through study completion, an average of 1 year
Secondary	success rate of heart team organization	to assess the successful-connection with cardiac surgeons during or after the coronary angiography	through study completion, an average of 1 year
Secondary	time consuming of heart team discussions	to assess the time consuming of heart team organization and discussion during or after the coronary angiography	through study completion, an average of 1 year
Secondary	length of stay	to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital	through study completion, an average of 1 year
Secondary	total cost	to assess the total cost in hospital for the initial hospitalization and rehospitalization	through study completion, an average of 3 year
Secondary	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	through study completion, an average of 1 year
Secondary	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	At 1 year after the coronary angiography