Exercise Therapy for Women With ANOCA: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 11
- 主要终点
- Seattle Angina Questionnaire
研究概览
简要总结
Angina is a feeling of chest pain or discomfort which can happen if there is reduced blood flow to the heart. Patients can experience angina with no obstructive coronary arteries (ANOCA) which is a difficult condition to treat (ie relieve angina) since few randomised, controlled therapy trials have been undertaken for ANOCA. Until now, angina has been mainly studied in men even though women are at least two-fold more likely than men to experience ANOCA.
In 2023, a Scientific Statement from the American Heart Association affirmed that resistance exercise training can improve or maintain muscle mass and strength and confer favourable physiological and clinical effects on cardiovascular disease and risk factors. Resistance exercise has not been assessed in ANOCA and it offers an important opportunity to study non drug alternatives to treatment for women.
This study will use a resistance based exercise programme to investigate if symptoms of ANOCA can be improved in women. It will recruit at least 76 patients (maximum 152 patients) across 13 hospitals in the UK and the Netherlands.
The study will use a randomised wait list control design. This means all participants will be offered the intervention, but the randomisation will decide when they undergo it.
It is part of a platform of trials for women with ANOCA. We are also setting up a drug study called ANOCA Therapy and a cohort study called ANOCA- Diagnosis.
详细描述
There is a gap in knowledge on evidence-based therapy for ANOCA. Stratified medicine is a population-level diagnostic approach for identifying endotypes in a heterogenous population of all-comers. An endotype is defined as a subtype of a condition, which must be characterised by a distinct functional or pathophysiological mechanism.
Use of quantitative noninvasive and invasive diagnostic methods, such as magnetic resonance imaging and coronary function tests involving acetylcholine testing, enables more accurate identification and discrimination of causal endotypes of ANOCA. This is especially relevant for women with ANOCA who have historically been under-recognised.
Quantitative diagnostic methods should bring an end to empirical therapy, therapeutic nihilism and sex disparities in ANOCA.
Precision medicine is different. Precision medicine targets the individual (and their endotype) with a mechanism informed therapy. Accordingly, in this Wellcome Leap Visible project, we will employ a stratified medicine diagnostic approach in women with suspected ANOCA undergoing invasive CFTs in multiple hospitals and then employ a precision medicine strategy by offering each woman an endotype-informed therapy option.
Resistance exercise has not been previously investigated in ANOCA and it therefore represents a novel therapeutic option. This lifestyle intervention will increase the range of trial options, maximize patient choice for participation, and facilitate timely delivery of this project. The beneficial effects of resistance exercise on cardiovascular function have recently been endorsed in a Scientific Statement from the American Heart Association and further supported by a systematic review and favourable experience in our recent randomized trial in Long COVID.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Angina with no obstructive coronary arties (ANOCA)
- •Myocardial perfusion reserve or coronary flow reserve recorded within three years
- •Seattle Angina Questionnaire frequency score ≤60
- •Duke Activity Status Index ≤34
排除标准
- •Age <18 years
- •Unable to provide informed consent
- •- Unable to comply with the protocol
- •Currently undertaking resistance exercise activities
结局指标
主要结局
Seattle Angina Questionnaire
时间窗: Change from Baseline to Week 9
The Seattle Angina Questionnaire a validated 19-item patient-reported survey used to measure coronary artery disease and angina treatment efficacy. Patients will complete on paper or electronically. The scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life.
次要结局
- Myocardial perfusion reserve (MPR)(Change from baseline to week 9)
- Handgrip strength using hand dynamometer(Change from baseline to week 9)
- Short Physical Performance Battery (SPPB)(Change from baseline to week 9)
- Brief Illness perception Questionnaire (Brief IPQ)(Change from baseline to week 9)
- Patient Health Questionnaire-4 of (PHQ4)(Change from Baseline to Week 9)
- Duke Activity Status Index (DASI)(From Baseline to Week 9)
- EQ-5D (EQ-5D-5L)(Change from Baseline to Week 9)
- International Physical Activity Questionnaire (IPAQ)(Change from Baseline to Week 9)
- Fatigue severity scale questionnaire(Change from Baseline to Week 9)
- Short Form Post-Exercise Malaise Questionnaire(Change from Baseline to Week 9)
- Episodes of care (primary, secondary, physiotherapy, rehabilitation)(Week 9)
- Hospitalisation for any reason by electronic health record review (where available) up to 4 months (Visit 3)(Week 17)