Impact of exercise on coronary microvascular disease
Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients With Coronary Microvascular Disease.
This study is testing if combining exercise with standard heart medication can improve how people with coronary microvascular disease feel and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CoreAalst BV Industry-sponsored |
| Locations | 1 site (Aalst, East-Flanders) |
| Trial ID | NCT05810051 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of cardiac rehabilitation combined with optimal medical therapy on patient-reported outcomes in individuals with coronary microvascular disease and non-obstructive coronary artery disease. Participants will undergo a microvascular assessment and those meeting specific criteria will be randomized to receive either optimal medical therapy alone or in combination with a structured cardiac rehabilitation program. The study aims to include approximately 204 subjects at a single center in Belgium, with a focus on personalized physical training over 36 sessions.
Who should consider this trial
Good fit: Ideal candidates are individuals with non-obstructive coronary artery disease, experiencing angina, and showing evidence of microvascular dysfunction.
Not a fit: Patients with acute coronary syndrome, severe valve disease, or those unable to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and health outcomes for patients with coronary microvascular disease.
How similar studies have performed: Other studies have shown promising results with cardiac rehabilitation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non obstructive CAD (diameter stenosis \<50% visual or FFR \> 0.80) * Angina at presentation * Evidence of microvascular dysfunction (IMR ≥ 25) Exclusion Criteria: * Inability to give consent * Acute coronary syndrome (ACS) * Severe valve disease * Permanent AF * History of coronary artery bypass grafting (CABG) * Cardiomyopathies * Intolerance to adenosine * Hemodynamic instability * Not able to exercise
Where this trial is running
Aalst, East-Flanders
- OLV Aalst — Aalst, East-Flanders, Belgium (Recruiting)
Study contacts
- Study coordinator: Sofie Pardaens, PhD
- Email: sofiepardaens@coreaalst.com
- Phone: 0032 53 72 42 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.