A feasibility study of using a novel lifestyle change programme (Super Rehab) to reverse coronary artery disease

Not Applicable

• Conditions: Coronary artery disease; Circulatory System; Atherosclerotic heart disease

• Registration Number: ISRCTN14603929
• Lead Sponsor: Royal United Hospital Bath NHS Trust

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-080735 (added 13/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-26
• Last Update Posted: 8 January 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Current inclusion criteria as of 13/10/2022:

1. 18 - 75 years of age
2. Confirmed coronary artery disease on CT coronary angiography, with at least one coronary artery with plaque affecting =25% of the lumen, and 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 artery)
3. Have Metabolic Syndrome, defined as meeting any 3 of the following within 6 months of their cardiac CT: high abdominal waist circumference (=94cm males, =80cm females), hypertension (=130/85mmHg or on treatment), raised fasting glucose or HbA1c (glucose =5.6mmol/L, HbA1c =42mmol/L or on diabetic treatment), low HDL (=1mmol/L males, <1.3mmol/L females), and high triglycerides (>1.7mmol/L)
4. Able and willing to safely comply with all study procedures
5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study

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Previous inclusion criteria:

1. 18 - 75 years of age
2. Confirmed coronary artery disease on CT coronary angiography, with at least one coronary artery with plaque affecting =25% of the lumen, and evidence of coronary inflammation, as defined by an abnormal fat attenuation index of >-70.1HU
3. Meet streamlined criteria for identification of metabolic syndrome, including a high body mass index of >28 kg/m2, and abnormal blood glucose control (defined as HbA1c >42 mmol/mol / >6%)
4. Able and willing to safely comply with all study procedures
5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study

Exclusion Criteria

1. Prognostic coronary artery disease, defined as left main stem >50% stenosis, flow-limiting disease in the proximal left anterior descending artery, or at least moderate disease in =3 major epicardial vessels
2. Unstable angina
3. New York Heart Association class III/IV heart failure or severe left ventricular impairment
4. Significant cardiomyopathy (as assessed by a cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
5. Severe heart valve disease
6. Severe hypertension (BP >180/120 mmHg) despite optimising anti-hypertensive therapy
7. Uncontrolled cardiac arrhythmia or higher degree heart block
8. History of 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 of fever
12. Significant acute or chronic renal failure
13. Pulmonary fibrosis or interstitial lung disease
14. Physically unable to participate in high-intensity exercise
15. A history of prior heart attack or coronary re-vascularisation (entitled to existing cardiac rehabilitation)
16. Severe coronary calcification precluding assessment of the coronary lumen on CT coronary angiography
17. A clinically significant ECG abnormality at the screening visit, which in the opinion of the investigators exposes the subject to risk by enrolling in the trial
18. Pregnant or breastfeeding
19. Participation in another intervention-based research study
20. Inability to fully understand the instructions provided during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment rates, measured as the proportion of eligible patients who accept invitation to participate in the study, at baseline<br>2. Retention rates, measured as the proportion of enrolled individuals who successfully complete the end-point assessments of the study at 15 months<br>3. Adherence rates, measured as the proportion of offered sessions completed for participants in the intervention group<br>4. Acceptability of the intervention, study design and outcome measures as well as participants’ and clinicians’ experiences of Super Rehab and its training resources, measured with interviews at the end of each of the 3 phases of the intervention and study completion

Secondary Outcome Measures

Name	Time	Method
1. To evaluate data collection procedures and outcome measures (clinical, intervention and health economic parameters), measured for each time-point of data collection (baseline, 6 months, 12 months and 15 months from study entry).<br>2. To pilot the use of routinely available clinical data (body mass index and HbA1c) for identifying patients with metabolic syndrome (as per the international consensus definition), assessed at baseline.<br>3. To obtain preliminary data for changes in coronary artery disease (measured by the peri-coronary fat attenuation index on CT coronary angiography) to inform power calculations for a subsequent randomised controlled trial, measured at 6 and 12 month time-points. <br>4. To work with the Patient Advisory Group to establish the key characteristics required in intervention delivery, including sites, continuously through the study.