Why the study?
Definitive evidence demonstrating the benefit of cardiac rehabilitation in a primary prevention setting is lacking, and patients with CAD and coexistent risk factors remain at high risk of MACE despite current management.
Does adding an intensive lifestyle intervention (Super Rehab) to usual care prove feasible to deliver and evaluate for coronary artery disease regression in patients with stable coronary artery disease, coronary inflammation, and metabolic syndrome?
Does adding an intensive lifestyle intervention (Super Rehab) to usual care prove feasible to deliver and evaluate for coronary artery disease regression in patients with stable coronary artery disease, coronary inflammation, and metabolic syndrome?
This study protocol outlines a multicentre randomised feasibility trial evaluating whether an intensive, cardiology-led lifestyle and high-intensity exercise programme (Super Rehab) can be delivered to high-risk patients with stable coronary artery disease and metabolic syndrome to inform a definitive trial on plaque regression.
Supports testing intensive rehab in CAD+MetS; leaves open whether regression is achievable in definitive trials.
INTRODUCTION: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting. METHODS AND ANALYSIS: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. TRIAL REGISTRATION NUMBER: ISRCTN14603929.
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Graby et al. (2023) studied this question.
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