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

Coronary Artery Disease Clinical Trial

Official title:

Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05563584
• Other study ID #: RUH Bath NHS SR CAD
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Royal United Hospitals Bath NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Metabolic Syndrome
• Myocardial Ischemia

Intervention

Behavioral:
• Super Rehab
A 12-month healthcare-delivered lifestyle intervention involving exercise and nutritional support

Locations

Country	Name	City	State
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath

Sponsors (7)

Lead Sponsor	Collaborator
Royal United Hospitals Bath NHS Foundation Trust	Forever Friends Appeal, United Kingdom, National Institute for Health Research, United Kingdom, North Bristol NHS Trust, University of Bath, University of Bristol, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Evaluate data collection procedures	To confirm that all data collection procedures (clinical, intervention and health economic data points) are achievable. This will be assessed as a percentage of the total number data-points we attempt to collect.	Month 15
Secondary	Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome	The percentage of patients recruited who meet international consensus metabolic syndrome diagnostic criteria that have a body mass index >28kg/m2 and an HbA1c >42mmol/mol.	Month 15
Secondary	Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index	To obtain preliminary data for coronary artery disease regression with Super Rehab when assessed with peri-coronary fat attenuation index (mean change in control vs intervention arms), to inform power calculations for a future randomised controlled trial.	Month 12
Secondary	Establish key characteristics required in intervention delivery	A qualitative analysis of interviews with the study Patient Advisory Group will report the key characteristics required in the intervention (Super Rehab) delivery for a successful future study.	Month 15

External Links

•   Research team website outlining research goals