Back to resultsSuper-Rehab: Can we Achieve Coronary Artery Disease Regression?
Primary Purpose
Coronary Artery Disease, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Super Rehab
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Lifestyle risk reduction, Exercise, Inflammation, Behavior modifications, Nutrition therapy, Diet, Feasibility studies, Cardiovascular disease
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- Severe coronary calcification that precludes assessment of the coronary lumen on CCTA
- 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
- Pregnant or breastfeeding
- Current participation in another intervention based research study
- Inability to fully understand the verbal and written descriptions of the study and the instructions provided during the study.
Sites / Locations
- Royal United Hospitals Bath NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Super Rehab plus Usual Care
Arm Description
Patients will continue Usual Care, which will include aspirin, a statin and routine lifestyle advice
12-month Super Rehab programme plus Usual Care
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05563584
First Posted
January 4, 2022
Last Updated
September 29, 2022
Sponsor
Royal United Hospitals Bath NHS Foundation Trust
Collaborators
University of Bath, University of Oxford, University of Bristol, National Institute for Health Research, United Kingdom, Forever Friends Appeal, United Kingdom, North Bristol NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT05563584
Brief Title
Super-Rehab: Can we Achieve Coronary Artery Disease Regression?
Official Title
Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal United Hospitals Bath NHS Foundation Trust
Collaborators
University of Bath, University of Oxford, University of Bristol, National Institute for Health Research, United Kingdom, Forever Friends Appeal, United Kingdom, North Bristol NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 > -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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Metabolic Syndrome
Keywords
Lifestyle risk reduction, Exercise, Inflammation, Behavior modifications, Nutrition therapy, Diet, Feasibility studies, Cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to Usual Care or Super Rehab plus Usual Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients will continue Usual Care, which will include aspirin, a statin and routine lifestyle advice
Arm Title
Super Rehab plus Usual Care
Arm Type
Experimental
Arm Description
12-month Super Rehab programme plus Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Super Rehab
Intervention Description
A 12-month healthcare-delivered lifestyle intervention involving exercise and nutritional support
Primary Outcome Measure Information:
Title
Establish recruitment rate
Description
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.
Time Frame
Week 0
Title
Establish retention rate
Description
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.
Time Frame
Month 15
Title
Establish adherence
Description
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.
Time Frame
Month 12
Title
Assess acceptability of the intervention
Description
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.
Time Frame
Month 12
Title
Assess acceptability of the study design
Description
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.
Time Frame
Month 15
Secondary Outcome Measure Information:
Title
Evaluate data collection procedures
Description
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.
Time Frame
Month 15
Title
Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome
Description
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.
Time Frame
Month 15
Title
Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index
Description
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.
Time Frame
Month 12
Title
Establish key characteristics required in intervention delivery
Description
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.
Time Frame
Month 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Severe coronary calcification that precludes assessment of the coronary lumen on CCTA
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
Pregnant or breastfeeding
Current participation in another intervention based research study
Inability to fully understand the verbal and written descriptions of the study and the instructions provided during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Graby
Phone
01225 824160
Email
john.graby@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Rodrigues
Phone
01225821095
Email
j.rodrigues1@nhs.net
Facility Information:
Facility Name
Royal United Hospitals Bath NHS Foundation Trust
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Graby
Phone
01225 824160
Email
john.graby@nhs.net
First Name & Middle Initial & Last Name & Degree
Jonathan CL Rodrigues
First Name & Middle Initial & Last Name & Degree
Ali Khavandi
First Name & Middle Initial & Last Name & Degree
Dylan Thompson
First Name & Middle Initial & Last Name & Degree
Fiona Gillison
First Name & Middle Initial & Last Name & Degree
John Graby
12. IPD Sharing Statement
Links:
URL
http://www.ruh.nhs.uk/SuperRehab
Description
Research team website outlining research goals
Learn more about this trial
Super-Rehab: Can we Achieve Coronary Artery Disease Regression?
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