Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial)

Abstract

IntroductionThe implementation of a heart team still faces many challenges which may be facilitated with advanced communication technology. There is a knowledge gap to support the use of an electronic real-time heart team decision-making approach based on communication technology in the real clinical practice and evaluate its safety and feasibility in patients with complex coronary artery disease (CAD).Methods and analysisThe EHEART (Electronic HEArt team with Real-Time decision-making) trial is a prospective, multicentre, two-arm, randomised controlled trial that will randomise 490 patients with complex CAD to either an electronic real-time heart team group or conventional heart team group. For patients allocated to the real-time electronic group, heart team meetings will be initiated during the coronary angiography and guided by a supporting system based on communication technology to help with information synchronisation, real-time communication between specialists, meeting process recording and assistance and joint decision-making with patients’ families. The primary and safety endpoint is a composite of all-cause death, myocardial infarction, stroke, revascularisation or re-angina hospital admission at 1 year. The primary secondary outcome is the time interval from the coronary angiography to the final treatment, which is the major indicator of feasibility. We will also compare the practical feasibility from the specialist’s and patient’s perspectives (for example, specialist’s workload and patient’s decision results) between the two groups.Ethics and disseminationThe study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (no. 2022-1749). Informed consent will be obtained from all participants. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.Trial registration numberClinicalTrials.gov Registry (NCT05514210).