“Super Rehab”: Can we achieve coronary artery disease regression? (a feasibility study)

Background Coronary artery disease (CAD) continues to cause significant morbidity and mortality in the UK.

CAD is a progressive inflammatory condition that results in plaque deposition in the vascular wall of coronary arteries.

Approximately half of patients with CAD have metabolic syndrome (MetS), and risk of mortality from myocardial infarction in CAD patients with MetS (CAD-MetS) is 3-fold higher than in other CAD patients.

Current treatment and management of CAD focusses on plaque stabilisation (e.g., via medications and expensive invasive treatments such as stents), but recent research indicates that it is possible to achieve CAD regression with substantial changes to lifestyle (diet and exercise). Such intensified interventions are not currently available via the NHS.

Thus, in line with the NHS Long Term plan, we will examine the feasibility of implementing intensified lifestyle intervention (Super Rehab) in higher risk CAD patients (CAD-MetS).

Our longer-term goal is to use Super Rehab for patients with CAD-MetS throughout the NHS to significantly improve patient outcomes (including plaque regression) and generate substantial long-term cost savings.

Research Question Is it feasible to conduct a randomised, controlled trial of an intensified dietary and exercise intervention (Super Rehab) in CAD-MetS patients, with the aim of reversing CAD?

Aims To test the feasibility of undertaking a randomised controlled trial (RCT) evaluating whether Super Rehab can induce coronary regression in CAD-MetS patients, assessing: 1) recruitment, retention and adherence rates, 2) intervention acceptability, 3) data collection and analysis, and 4) the proposed cost-effectiveness framework.

Methods We will conduct a multi-centre, two parallel-arm, randomised feasibility study of Super Rehab in individuals with CAD-MetS. We will enrol 50 individuals (25 intervention, 25 control) across South West England. Participants will be allocated 1:1 to Super Rehab or usual care, with both groups continuing usual care.

Super Rehab will incorporate high-intensity, 1:1 supervised exercise, prescribed home-work exercise and personalised dietary support led by a nutritionist. The overall multi-disciplinary team will be led by a Consultant Cardiologist. Session frequency will reduce over a 12-month period across 3 phases (induction, consolidation, maintenance).

Key assessments will be undertaken at 0, 6, 12 and 3 month follow-up at 15 months with end-of-study qualitative interviews of participants and the multi-disciplinary delivery team.

Timelines for delivery Months 1-3: Secure ethics approvals and finalise project infrastructure and recruitment processes. Months 4-10: Recruit 50 participants, secure consent, randomisation, and complete assessments. Months 4-22: Delivery of intervention, all assessments.

Months 23-24: Data analysis (quantitative and qualitative), manuscript preparation, initiate proposal for RCT, dissemination and study closure.

Anticipated Impact & Dissemination This feasibility study will inform a definitive, multicentre RCT to establish the impact of Super Rehab in CAD-MetS patients.

Results will be disseminated via peer-reviewed publications, conference presentations and websites to a wide audience including clinicians, researchers and patients.

If the subsequent multi-centre RCT shows that Super Rehab is cost-effective, we would work with key stakeholders to promote the implementation of Super Rehab in this target population across the NHS.