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

NCT05563584 | Completed

• 1 other identifier: RUH Bath NHS SR CAD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Metabolic Syndrome

Keywords

Lifestyle risk reduction; Exercise; Inflammation; Behavior modifications; Nutrition therapy; Diet; Feasibility studies; Cardiovascular disease

Outcome Measures

Primary Outcomes (5)

• Establish recruitment rate

  A key feasibility outcome for a potential future randomised controlled trial will be to establish recruitment rates: defined as the proportion of eligible patients who accept the invitation to participate in the study.

  Week 0

• Establish retention rate

  A key feasibility outcome for a potential future randomised controlled trial will be to examine retention: defined as the proportion of recruited participants who complete the study.

  Month 15

• Establish adherence

  A key feasibility outcome for a potential future randomised controlled trial will be to examine adherence: defined as, for participants in the intervention arm, the proportion of offered sessions completed.

  Month 12

• Assess acceptability of the intervention

  A key feasibility outcome for a potential future randomised controlled trial will be to examine the acceptability of the intervention (Super Rehab) to participants and clinicians. This will be assessed qualitatively by an end of study interview.

  Month 12

• Assess acceptability of the study design

  A key feasibility outcome for a potential future randomised controlled trial will be to examine the acceptability of the study design. This will be assessed qualitatively by an end of study interview.

  Month 15

Secondary Outcomes (4)

• Evaluate data collection procedures

  Month 15

• Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome

  Month 15

• Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index

  Month 12

• Establish key characteristics required in intervention delivery

  Month 15

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will continue Usual Care, which will include aspirin, a statin and routine lifestyle advice

Super Rehab plus Usual Care

EXPERIMENTAL

12-month Super Rehab programme plus Usual Care

Behavioral: Super Rehab

Interventions

Super Rehab BEHAVIORAL

A 12-month healthcare-delivered lifestyle intervention involving exercise and nutritional support

Super Rehab plus Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• Coronary artery disease requiring revascularisation
• Unstable angina
• New York Heart Association class III/IV heart failure or severe left ventricular impairment
• Severe valve disease
• Significant cardiomyopathy (as assessed by screening Cardiologist)
• Severe hypertension (defined as blood pressure \>180/120mmHg)
• Uncontrolled cardiac arrhythmia
• Previous aortic dissection
• Recent acute pulmonary embolus deep vein thrombosis, stroke or transient ischaemic attack
• Severe autonomic or peripheral neuropathy
• Acute systemic illness or fever
• Significant acute or chronic renal failure
• Pulmonary fibrosis or interstitial lung disease
• Physically unable to participate in exercise
• Previous myocardial infarction or coronary re-vascularisation

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator
• University of Oxford: collaborator
• University of Bristol: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• North Bristol NHS Trust: collaborator
• RUHX: collaborator

Study Sites (1)

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

Related Links

• Research team website outlining research goals

MeSH Terms

Conditions

Coronary Artery Disease; Metabolic Syndrome; Risk Reduction Behavior; Motor Activity; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomized to Usual Care or Super Rehab plus Usual Care

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: October 3, 2022
• Study Start: February 1, 2022
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: February 13, 2025

Record last verified: 2023-11

Locations

GB (1)