Coronary Artery DiseaseNCT05563584
Super-Rehab: Can we Achieve Coronary Artery Disease Regression?
A study testing Super Rehab in people with Coronary Artery Disease and Metabolic Syndrome, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Metabolic Syndrome
- What is being tested?
- Super Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2022to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
About this study
Official title: Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Metabolic Syndrome
- Being tested
- Super Rehab
- Keywords
- Lifestyle risk reduction, Exercise, Inflammation, Behavior modifications, Nutrition therapy, Diet, Feasibility studies, Cardiovascular disease
- Medical subject headings
- Coronary Artery Disease, Metabolic Syndrome, Risk Reduction Behavior, Motor Activity, Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super RehabBehavioural
A 12-month healthcare-delivered lifestyle intervention involving exercise and nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will continue Usual Care, which will include aspirin, a statin and routine lifestyle advice |
| Super Rehab plus Usual Care | Experimental | 12-month Super Rehab programme plus Usual Care Receives: Behavioral: Super Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0
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.
Measured: Month 15
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.
Measured: Month 12
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.
Measured: Month 12
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.
Measured: Month 15
Secondary outcomes (4)
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.
Measured: Month 15
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.
Measured: Month 15
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.
Measured: Month 12
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.
Measured: Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Feb 2022
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to Usual Care or Super Rehab plus Usual Care
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, University of Oxford, University of Bristol, National Institute for Health Research, United Kingdom, North Bristol NHS Trust, RUHX
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563584
- Sponsor's protocol ID
- RUH Bath NHS SR CAD
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)
- ClinicalTrials.gov ID
- NCT05563584
- Acronym / sponsor ID
- RUH Bath NHS SR CAD
- Conditions
- Coronary Artery Disease, Metabolic Syndrome
- Keywords
- Lifestyle risk reduction, Exercise, Inflammation, Behavior modifications, Nutrition therapy, Diet, Feasibility studies, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bath, University of Oxford, University of Bristol, National Institute for Health Research, United Kingdom, North Bristol NHS Trust, RUHX
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized to Usual Care or Super Rehab plus Usual Care
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will continue Usual Care, which will include aspirin, a statin and routine lifestyle advice |
| Super Rehab plus Usual Care | Experimental | Behavioral: Super Rehab12-month Super Rehab programme plus Usual Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super RehabA 12-month healthcare-delivered lifestyle intervention involving exercise and nutritional support | Behavioural | Super Rehab plus Usual Care |
Primary outcome
Establish recruitment rate
Time frame: Week 0
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
Time frame: Month 15
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
Time frame: Month 12
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
Time frame: Month 12
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
Time frame: Month 15
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.
4 secondary outcomes
Evaluate data collection procedures
Time frame: Month 15
Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome
Time frame: Month 15
Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index
Time frame: Month 12
Establish key characteristics required in intervention delivery
Time frame: Month 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Research team website outlining research goalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Rehab in people with Coronary Artery Disease and Metabolic Syndrome, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish recruitment rate (time frame: Week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.