Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05563584
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-01-04
Brief Title:
Super-Rehab Can we Achieve Coronary Artery Disease Regression
Sponsor:
Royal United Hospitals Bath NHS Foundation Trust
Organization:
Royal United Hospitals Bath NHS Foundation Trust
Study Overview
Official Title:
Super-Rehab Can we Achieve Coronary Artery Disease Regression a Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 -701HU 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 13085mmHg or on treatment raised fasting glucose 56mmolL or on diabetic treatment low HDL 1mmolL males 13mmolL females and high triglycerides 17mmolL
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only Super Rehab includes a combination of separate 11 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 eg 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
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 -701HU 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 13085mmHg or on treatment raised fasting glucose 56mmolL or on diabetic treatment low HDL 1mmolL males 13mmolL females and high triglycerides 17mmolL
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only Super Rehab includes a combination of separate 11 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None