Clinical trial NCT05563584: Super-Rehab: Can we Achieve Coronary Artery Disease Regression?
Official title: Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Metabolic Syndrome
Keywords: Lifestyle risk reduction
Exercise
Inflammation
Behavior modifications
Nutrition therapy
Diet
Feasibility studies
Cardiovascular disease
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bath
name: University of Oxford
name: University of Bristol
name: National Institute for Health Research, United Kingdom
name: North Bristol NHS Trust
name: RUHX
First posted: 2022-10-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to Usual Care or Super Rehab plus Usual Care
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. CCTA demonstrating coronary artery disease with plaque causing a narrowing in at least 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 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)
2. 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).

Exclusion Criteria:

1. Coronary artery disease requiring revascularisation
2. Unstable angina
3. New York Heart Association class III/IV heart failure or severe left ventricular impairment
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 ischaemic attack
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 on CCTA
17. A clinically significant ECG abnormality at the screening visit, which in the opinion of the screening Cardiologist exposes the subject to risk by enrolling in the 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 and the instructions provided during the study.

Primary outcomes:
measure: Establish recruitment rate
timeFrame: Week 0
measure: Establish retention rate
timeFrame: Month 15
measure: Establish adherence
timeFrame: Month 12
measure: Assess acceptability of the intervention
timeFrame: Month 12
measure: Assess acceptability of the study design
timeFrame: Month 15
Secondary outcomes:
measure: Evaluate data collection procedures
timeFrame: Month 15
measure: Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome
timeFrame: Month 15
measure: Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index
timeFrame: Month 12
measure: Establish key characteristics required in intervention delivery
timeFrame: Month 15
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
Study officials:
References: