Super-Rehab: Can we Achieve Coronary Artery Disease Regression? (a Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Establish adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Establish adherence
时间窗: 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.
Establish recruitment rate
时间窗: 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
时间窗: 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.
Assess acceptability of the intervention
时间窗: 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
时间窗: 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.
次要结局
- Assess the use of routine clinical data (combination of body mass index and HbA1c) for identifying coronary artery disease patients with metabolic syndrome(Month 15)
- Evaluate data collection procedures(Month 15)
- Establish preliminary data for coronary artery disease regression with this intervention assessed with the peri-coronary fat attenuation index(Month 12)
- Establish key characteristics required in intervention delivery(Month 15)