Personalized exercise and dietary program for patients with microvascular coronary dysfunction
Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study
This study is testing a personalized exercise and diet program to see if it helps people with microvascular coronary dysfunction feel better and manage their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal United Hospitals Bath NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Bath and 1 other locations) |
| Trial ID | NCT06681896 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of a personalized, intense cardiac rehabilitation program called MICROFIT, which combines high intensity interval exercise training and dietary advice, for patients suffering from microvascular coronary dysfunction. The study will evaluate recruitment rates, retention, adherence, and the acceptability of the intervention among participants and practitioners. Additionally, it will gather preliminary data on the impact of MICROFIT on angina symptoms, measured by the Seattle Angina Questionnaire, and assess the fidelity and clinical efficacy of the program. Participants will be randomized into either the MICROFIT group or a usual care group.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed microvascular coronary dysfunction and experiencing angina symptoms.
Not a fit: Patients with severe heart failure, significant cardiomyopathy, or other serious cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce angina symptoms and improve the quality of life for patients with microvascular coronary dysfunction.
How similar studies have performed: While this approach is novel in its specific application to microvascular coronary dysfunction, similar lifestyle interventions have shown promise in improving cardiovascular health in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Angina or angina equivalent symptoms * Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \<40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8 * Evidence of microvascular dysfunction on ICA (CFR \<2.5 and/or AchFR \<1.5) Exclusion Criteria: * New York Heart Association class III/IV heart failure * Severe left ventricular impairment (ejection fraction≤35%) * Severe heart valve disease * Significant cardiomyopathy (as assessed by a cardiologist) * Severe hypertension (defined as blood pressure \>180/120mmHg (despite three anti-hypertensive agents) * Uncontrolled arrhythmia * A history of aortic dissection, recent (\<6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise) * Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT) * Physical inability to participate in exercise * Significant claustrophobia or metallic implants which would limit MRI imaging * Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease) * Current participation in another intervention-based trial * Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.
Where this trial is running
Bath and 1 other locations
- Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom (Recruiting)
- University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ali Khavandi — Royal United Hospitals Bath NHS Foundation Trust
- Study coordinator: Joanna Abramik
- Email: joanna.abramik1@nhs.net
- Phone: +44 1225 82109
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.