Clinical trial NCT05039567: Effect of an Optimal Heart Team Protocol on Decision-making Stability
Official title: The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Heart Team protocol
Coronary Artery Disease
decision-making agreement
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-09-09
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Overall percent agreement
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Kappa value of heart team decision-making
timeFrame: through study completion, an average of 1 year
measure: Inappropriate decision rate
timeFrame: through study completion, an average of 1 year
measure: Compliance rate in real-world treatment
timeFrame: through study completion, an average of 1 year
measure: Reproducibility of decision-making
timeFrame: At 1-month after first phase of heart team meeting
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: