Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

Launched by ROYAL UNITED HOSPITALS BATH NHS FOUNDATION TRUST · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new rehabilitation program called MICROFIT to see if it can help patients with microvascular coronary dysfunction, which is a condition that affects the small blood vessels in the heart and can cause chest pain known as angina. The trial will compare two groups: one group will receive the MICROFIT program, which includes personalized high-intensity exercise training and dietary advice, while the other group will receive standard care. Researchers want to find out if it's feasible to conduct a larger study and gather initial information on how well MICROFIT can reduce angina symptoms.

To participate in this trial, you need to be at least 18 years old and have symptoms of angina, but your coronary arteries must not be blocked. You will undergo several tests to check your heart health at the beginning and after six months. If you join the MICROFIT group, you will work with a personal trainer and a dietitian over 24 weeks, while both groups will be monitored for their progress. This study will help researchers understand if this program is effective and acceptable for patients with this condition.

Gender

ALL

Eligibility 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.