Effect of an Optimal Heart Team Protocol on Decision-making Stability

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: optimal heart team protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05039567

2019-1303-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

1. prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
2. cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
3. concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
4. concomitant atrial fibrillation or severe arrhythmia

Eligibility Criteria for specialists:

Inclusion Criteria for interventional cardiologists:

1. Annual PCI volume ≥200
2. Annual left main PCI volume ≥25
3. Capable of chronic total occlusion(CTO) PCI
4. Clinical researcher experience in coronary revascularization
5. Proficient in clinical guidelines

Inclusion Criteria for cardiac surgeons:

1. CABG total volume ≥200
2. Proficient in both on-pump and off-pump CABG
3. Clinical researcher experience in coronary revascularization
4. Proficient in clinical guidelines

Inclusion Criteria for non-interventional cardiologists:

1. Proficient in clinical guidelines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

optimal heart team group

Experimental group

Description:

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.

Treatment:

Behavioral: optimal heart team protocol

conventional heart team group

No Intervention group

Description:

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.