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Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

RecruitingNAAges 18 Years - anyAllRoyal United Hospitals Bath NHS Foundation Trust
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction. The main questions it aims to answer are: 1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation) 2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire 3. Preliminary data on the fidelity and clinical efficacy of MICROFIT Partic

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📋 Eligibility rules (as published)
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.
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What it tests

  • MICROFIT - personalised high intensity interval training exercise rehabilitation and dietary advice
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Where

2 sites
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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