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Published on: June 28, 2019
Effect of enhanced external counterpulsation on coronary microcirculation dysfunction (CMD) in patients with coronary
Fan Cao1, Yuxin Liu2, Wenbin Wei2
1The Eighth Affiliated Hospital of Sun Yat-Sen University, Shenzhen, Guangdong Province, China.
Insights
This study investigates if enhanced external counterpulsation (EECP) improves coronary microcirculation dysfunction (CMD) in patients with coronary artery disease (CAD). Results will inform a larger trial on EECP effectiveness for CMD.
Area of Science:
- Cardiology
- Medical Technology
- Clinical Trials
Background:
- Coronary microcirculation dysfunction (CMD) is common in coronary artery disease (CAD).
- Current treatments for CMD primarily rely on pharmacotherapy.
- Enhanced external counterpulsation (EECP) shows promise for CAD but its effect on CMD is unproven.
Purpose of the Study:
- To evaluate the effectiveness of EECP in improving CMD in patients with CAD.
- To assess the feasibility of conducting a multicentre randomized controlled trial for EECP in CMD.
Main Methods:
- A single-centre, outcome-assessor-blinded, parallel randomized controlled trial.
- 110 participants with CAD will be randomized to EECP plus optimal medical therapy (OMT) or OMT alone.
- Primary outcome: change in Myocardial Perfusion Reserve Index via cardiac MRI.
Main Results:
- Study is currently recruiting participants; results are pending.
- The primary outcome measure is the change in Myocardial Perfusion Reserve Index.
- Secondary outcomes include patient retention rates.
Conclusions:
- The study aims to determine if EECP is a viable non-pharmacological treatment for CMD in CAD patients.
- Findings will guide the design and feasibility of future large-scale multicentre trials.
- This research addresses a critical gap in understanding EECP's role in managing CMD.
Introduction:
Coronary microcirculation dysfunction (CMD) is prevalent in patients with coronary artery disease (CAD). Current therapies for CMD are focused on pharmacotherapy, non-pharmacological treatments such as enhanced external counterpulsation (EECP) have shown favourable results in patients with CAD. However, whether EECP can improve CMD remains unknown. This study is designed to evaluate the effectiveness of EECP on CMD in patients with CAD, and to assess the feasibility of conducting a multicentre randomised controlled trial.
Methods And Analysis:
This study is a single-centre, outcome-assessor-blinded, parallel randomised controlled trial. A total of 110 participants with CAD will be included and randomly assigned to either the intervention group (EECP plus optimal medical therapy (OMT)) or the control group (OMT alone). EECP will be administered by operators for 60 min, 5 times per week for 7 weeks (35 times in total). Outcomes include patients' retention rates, the primary outcome and secondary outcomes. The primary outcome is the change in Myocardial Perfusion Reserve Index with cardiac MRI from baseline to the end of follow-up. The planned study duration is from 2024 to 2026.
Ethics And Dissemination:
Ethical approval was obtained from the Ethics Committee of the Eighth Affiliated Hospital, Sun Yat-sen University (ID: 2023-045-03). The findings will be disseminated in peer-reviewed publications.
Trial Registration Number:
ChiCTR2300076231.
