Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Establish recruitment rate
研究概览
简要总结
The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction.
The main questions it aims to answer are:
- Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation)
- Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire
- Preliminary data on the fidelity and clinical efficacy of MICROFIT
Participants will be randomized to either MICROFIT + Usual Care, or Usual Care group.
Participants in both arms of the trial will:
- Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months
- Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months
- Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months.
Participants in the intervention arm of the study will:
- Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves:
- 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home
- 1:1 sessions with a dietician to support them with improvements in diet.
- Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist
- Undergo an interview at the end of the study to discuss their experiences of participation in the study
- Receive a debrief on their investigation results and progress made at the end of their study
Participants in the Usual Care arm of the study will:
- Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction.
- Receive a debrief on their investigation results and progress made at the end of their study
- Undergo a 'taster' session with the personal trainer to discover what the intervention involves.
详细描述
The investigators hypothesise that an intensified and personalised healthcare delivered lifestyle intervention (MICROFIT) will improve anginal symptoms in patients with microvascular coronary dysfunction. As a first step to a multi-centre randomised controlled trial (RCT) to establish efficacy, this feasibility study will test the components and acceptability of the intervention, alongside preliminary data on change in anginal symptoms to guide the powering of the subsequent RCT.
Participants:
The investigators aim to recruit 40 participants (men and women) with confirmed coronary microvascular dysfunction identified via existing clinical pathways (following an invasive coronary angiography study resulting in a diagnosis of microvascular angina) at two study sites, the Royal United Hospitals Bath NHS Foundation Trust (RUH) and University Hospitals Bristol and Weston NHS Foundation Trust(UHBW). Invasive coronary angiography with a microvascular study is a gold standard assessment for microvascular dysfunction nationwide and thus would be transferrable to all sites in the proposed subsequent multicentre randomised controlled trial.
A named cardiologist at each site who will be a member of the research team will undertake the screening. Potential participants will be approached on the day of their attendance for microvascular dysfunction testing following the procedure, once microvascular dysfunction has been confirmed (as per inclusion criteria), or during a routine follow up appointment as part of usual care relating to the diagnosis of coronary microvascular disease. Potential participants will be informed of the experimental protocol both verbally and in writing before providing informed consent. The study will be conducted in accordance with the Declaration of Helsinki. Participants will be block randomised 1:1 using a web-based platform (Sealed Envelope: https://www.sealedenvelope.com/). Participants will be randomised to either usual care (control arm) or MICROFIT with usual care, in permuted blocks of four and stratified for sex. The control arm contributes to a robust assessment of feasibility (e.g. consent and attrition rates) and a comparator for the preliminary data on anginal symptom burden change.
TRIAL ARMS:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angina or angina equivalent symptoms
- •Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing <40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8
- •Evidence of microvascular dysfunction on ICA (CFR <2.5 and/or AchFR <1.5)
排除标准
- •New York Heart Association class III/IV heart failure
- •Severe left ventricular impairment (ejection fraction≤35%)
- •Severe heart valve disease
- •Significant cardiomyopathy (as assessed by a cardiologist)
- •Severe hypertension (defined as blood pressure >180/120mmHg (despite three anti-hypertensive agents)
- •Uncontrolled arrhythmia
- •A history of aortic dissection, recent (<6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise)
- •Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)
- •Physical inability to participate in exercise
- •Significant claustrophobia or metallic implants which would limit MRI imaging
- •Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)
- •Current participation in another intervention-based trial
- •Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.
研究组 & 干预措施
Usual Care
All patients will be reviewed clinically by a cardiologist. They will address cardiovascular risk factors and prescribe any therapies as indicated by current medical guidelines, for example statin or ACE inhibitors. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with NICE guidance, recommending 150 minutes of moderate exercise per week, encouraging a healthy, balanced diet, weight loss, reducing alcohol consumption and smoking cessation where necessary.
MICROFIT + Usual Care
MICROFIT intervention will be delivered in addition to Usual Care arm clinical review and advice. MICROFIT is a 24-week long personalized one-on-one exercise and dietary education intervention, along with home exercise guided by personal trainers. Exercise intervention includes High Intensity Interval Training (HIIT) and dietary advice focuses on incorporation of a Mediterranean-type diet.
干预措施: MICROFIT - personalised high intensity interval training exercise rehabilitation and dietary advice (Other)
结局指标
主要结局
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: Week 24
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
时间窗: Week 24
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
时间窗: Week 24
A key feasibility outcome for a potential future randomised controlled trial will be to examine the acceptability of the intervention (MICROFIT) to participants and clinicians. This will be assessed qualitatively by an end of study interview.
Assess acceptability of the study design
时间窗: Week 24
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
- Change in anginal symptom burden(Week 24)
- Change in myocardial perfusion with quantitative stress MRI(Week 24)
- Change in myocardial oxygenation(24 weeks)
- Change in cardiorespiratory fitness(24 weeks)
- Change in blood pressure control(24 weeks)
- Change in body fat composition(24 weeks)
- Change in body anthropometrics (Body Mass Index - BMI)(24 weeks)
- Change in anthropometrics - waist circumference(24 weeks)
- Change in glucose control, measured with the glycated haemoglobin test (HbA1c)(24 weeks)
- Change in serum lipid levels(24 weeks)
- Change in serum inflammatory markers(24 weeks)
- Change in left ventricular ejection fraction, measured on echocardiography(24 weeks)
- Change in left ventricular strain assessed on echocardiography(24 weeks)
- Change in left ventricular filling pressure measured on echocardiography(24 wees)
- Change in left atrial strain, measured on echocardiography(24 weeks)
- Change in self-perceived mental health, assessed with the Hospital Anxiety and Depression Scale (HADS)(24 weeks)
- Change in patient reported health-related quality-of-life, measured with the EuroQol Group (EuroQol) EQ-5D-5L questionnaire(24 weeks)
- Evaluate data collection procedures(Week 24)