Coronary artery disease Circulatory System Atherosclerotic heart disease
Conditions
Interventions
Randomisation:
Participants will be block randomised 1:1 after completion of all baseline assessments by an independent member of the host Research and Development department, who will have no other p
Sponsors
Royal United Hospital Bath NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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, 1.7mmol/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 _____ 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates, measured as the proportion of eligible patients who accept invitation to participate in the study, at baseline 2. Retention rates, measured as the proportion of enrolled individuals who successfully complete the end-point assessments of the study at 15 months 3. Adherence rates, measured as the proportion of offered sessions completed for participants in the intervention group 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
| Measure | Time frame |
|---|---|
| 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). 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. 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. 4. To work with the Patient Advisory Group to establish the key characteristics required in intervention delivery, including sites, continuously through the study. | — |
Countries
England, United Kingdom
Outcome results
None listed