Super-Rehab: Can we Achieve Coronary Artery Disease Regression?

Last updated: February 11, 2025
Sponsor: Royal United Hospitals Bath NHS Foundation Trust
Overall Status: Completed

Phase

N/A

Condition

Myocardial Ischemia

High Cholesterol (Hyperlipidemia)

Chest Pain

Treatment

Super Rehab

Clinical Study ID

NCT05563584
RUH Bath NHS SR CAD
  • Ages 18-75
  • All Genders

Study Summary

The Super Rehab: Can we Achieve Coronary Artery Disease Regression? (a feasibility study) proposes to test the use of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with both coronary artery disease and metabolic syndrome. This is a feasibility study that will test study processes, enable optimisation of the intervention and provide data for power calculations to enable design of pivotal trials of the clinical effectiveness of Super Rehab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. CCTA demonstrating coronary artery disease with plaque causing a narrowing in atleast one coronary artery of ≥ 25% stenosis and a evidence of coronary inflammation (defined by an abnormal fat attenuation index (FAI; defined as FAI > -70.1HU or withFAI score [relative to age and sex matched patients] ≥ 75th percentile in the leftanterior coronary or right coronary artery or with FAI score ≥ 90th percentile inthe circumflex coronary)

  2. Have Metabolic Syndrome, defined as any 3 of: high abdominal waist circumference (≥94cm males, ≥80cm females), hypertension (≥130/85mmHg or on treatment), raisedfasting glucose (≥5.6mmol/L or on diabetic treatment), low HDL (≤1mmol/L males, <1.3mmol/L females), and high triglycerides (>1.7mmol/L).

Exclusion

Exclusion Criteria:

  1. Coronary artery disease requiring revascularisation

  2. Unstable angina

  3. New York Heart Association class III/IV heart failure or severe left ventricularimpairment

  4. Severe valve disease

  5. Significant cardiomyopathy (as assessed by screening Cardiologist)

  6. Severe hypertension (defined as blood pressure >180/120mmHg)

  7. Uncontrolled cardiac arrhythmia

  8. Previous aortic dissection

  9. Recent acute pulmonary embolus deep vein thrombosis, stroke or transient ischaemicattack

  10. Severe autonomic or peripheral neuropathy

  11. Acute systemic illness or fever

  12. Significant acute or chronic renal failure

  13. Pulmonary fibrosis or interstitial lung disease

  14. Physically unable to participate in exercise

  15. Previous myocardial infarction or coronary re-vascularisation

  16. Severe coronary calcification that precludes assessment of the coronary lumen onCCTA

  17. A clinically significant ECG abnormality at the screening visit, which in theopinion of the screening Cardiologist exposes the subject to risk by enrolling inthe trial

  18. Pregnant or breastfeeding

  19. Current participation in another intervention based research study

  20. Inability to fully understand the verbal and written descriptions of the study andthe instructions provided during the study.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Super Rehab
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
August 07, 2023

Study Description

In this research we will study the feasibility of a randomised controlled trial (RCT) of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with established coronary artery disease (CAD) and metabolic syndrome. Increasing evidence has shown that CAD can not only be stabilised, but can in fact regress with treatments that include lifestyle interventions.

This feasibility study will involve patients undergoing a clinically indicated coronary CT angiography (CCTA) scan who are found to have confirmed CAD with plaque causing a narrowing in at least one coronary artery of ≥25% of the lumen on their CTCA; have evidence of coronary inflammation (defined by an abnormal fat attenuation index (FAI) of > -70.1HU or with FAI score [relative to age and sex matched patients] ≥ 75th percentile in the left anterior coronary or right coronary artery or with FAI score ≥ 90th percentile in the circumflex coronary); have Metabolic Syndrome, defined as any 3 of: high abdominal waist circumference (≥94cm males, ≥80cm females), hypertension (≥130/85mmHg or on treatment), raised fasting glucose (≥5.6mmol/L or on diabetic treatment), low HDL (≤1mmol/L males, <1.3mmol/L females), and high triglycerides (>1.7mmol/L).

Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of separate 1:1 supervised high-intensity exercise and dietary advice sessions, and the whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study, alongside short interim and detailed end-of-study interviews.

The study will primarily assess key feasibility outcomes to guide a potential subsequent RCT, e.g. recruitment and retention rates and test the acceptability of the intervention and study processes. In addition, the study will provide baseline data for power calculations to support study design for the planned future RCT into the clinical effectiveness of Super Rehab in this patient group.

Connect with a study center

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.