The Clinical Utility Of Cardiac Magnetic Resonance Imaging in Patients With Angina But No Obstructive Coronary Disease (CorCMR): A Diagnostic Study And Nested Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Reclassification of the initial diagnosis
研究概览
简要总结
Anginal symptoms due to ischaemia with no obstructive coronary arteries (INOCA) is a common clinical problem, however, diagnosis and onward management is heterogeneous, and prognosis is affected. Recent advances in quantifying myocardial blood flow using stress perfusion cardiac magnetic resonance imaging (CMR) has potential for accurate detection coronary microvascular dysfunction.
The CorCMR diagnostic study involves stress perfusion CMR in patients with suspected INOCA to clarify the prevalence of subgroups of patients with underlying problems, such as microvascular disease or undisclosed obstructive coronary artery disease, that might explain their anginal symptoms.
A nested, prospective, randomised, controlled, double-blind trial will determine whether stratified medical therapy guided by the results of the stress perfusion CMR improves symptoms, well-being, cardiovascular risk and health and economic outcomes.
详细描述
Background:
There are approximately 2 million men and women living with angina in the UK. In 2014, there were ~247,000 coronary angiograms performed, mostly for the investigation of known or suspected angina. However, obstructive CAD is detected in only 1 in 2 patients. The explanation for the cause(s) of the chest pain are often unclear. Microvascular or vasospastic angina may be one explanation.
Adjunctive tests of coronary artery function to diagnose these problems are rarely used during coronary angiography in the NHS, meaning that patient management may be empirical and heterogeneous. The lack of adoption of these novel tests in the NHS reflects key gaps in the clinical evidence. It is these gaps, coupled with the increasing adoption of anatomical coronary artery imaging with CT coronary angiography (CTCA), which stimulate this research. In recent large clinical trials, CT coronary angiography has been shown not to reduce the rate of invasive angiography. In fact, compared to standard care based on stress testing, CTCA is associated with less improvement in anginal symptoms and in quality of life (PUBMED ID: 28246175). Anatomical tests, such as CTCA and invasive angiography, do not provide information on myocardial blood flow. New evidence that addresses these gaps might inform therapy development and future trials.
Current gaps in evidence and guidelines point to a problem of unmet need in the NHS care pathway. Stress perfusion CMR has potential diagnostic value for microvascular disease, but whether it might discriminate clinical endotypes in a relatively unselected population of patients in daily practice, is uncertain. Further, access to stress perfusion CMR varies widely not least because evidence from randomised trials supporting clinical and economic benefits from a CMR-guided approach is lacking. CorCMR is a clinical strategy trial that is designed to address this evidence gap.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age ≥18 years
- •Symptoms of angina or angina-equivalent informed by the Rose Angina questionnaire.
- •Coronary angiography ≤3 months with a plan for medical management.
排除标准
- •Obstructive coronary artery disease i.e. a stenosis >70% in a single segment or 50 - 70% in 2 adjacent segments in an artery >2.5 mm, or FFR ≤0.
- •Coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft surgery following the index angiogram.
- •Prior coronary artery bypass surgery
- •A diagnosis that would explain the angina e.g. anaemia, aortic stenosis, hypertrophic cardiomyopathy,
- •Contra-indication to contrast-enhanced CMR e.g. eGFR < 30mL/min/1.73m
- •Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree AV block and sick sinus syndrome.
- •Lack of informed consent.
结局指标
主要结局
Reclassification of the initial diagnosis
时间窗: Day 1
The reclassification of the initial diagnosis based on invasive management following multi-parametric stress perfusion CMR. The diagnostic groups (endotypes) are: 1. Anginal symptoms with a myocardial perfusion defect indicative of obstructive CAD; 2. Anginal symptoms associated with a myocardial perfusion defect indicative of microvascular disease; 3. Vasospastic angina; 4. Incidental finding that is actionable e.g. aortic stenosis, cardiomyopathy, lung cancer; or 5. No clinically significant finding or normal.
Seattle Angina Questionnaire (SAQ) Summary Score
时间窗: 6 months
The 7-item version of the SAQ reflects the frequency of angina (SAQ Angina Frequency score) and the disease-specific effect of angina on patients' physical function (SAQ Physical Limitation score) and quality of life (Quality of Life score) over the previous 4 weeks; these scores are averaged to obtain the SAQ Summary score, which is an overall measure of patients' stable ischaemic heart disease-specific health status. SAQ scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life.
次要结局
- Health Status: EQ5D-5L Questionnaire(0-36 months)
- Health Status: Seattle Angina Questionnaire(0-36 months)
- Health Status: Illness Perception - Brief IPQ(0-36 months)
- Correlation between myocardial blood flow and health status(0-36 months)
- Angina events(0-3 years)
- Compliance with the protocol(0-36 months)
- Diagnostic utility(0-36 months)
- Between-group, within subject change in myocardial blood flow(0-12 months)
- Health Status: Treatment satisfaction - TSQM(0-36 months)
- Clinical Utility(0-36 months)
- Abnormal myocardial perfusion(Day 1)
- Cardiovascular risk(Day 1)
- Health Status: International Physical Activity Questionnaire- Short Form (IPAQ-SF)(0-36 months)
- Integrity of blinding in the Radiology Department and during follow-up(0-36 months)
- Myocardial blood flow(Day 1)
- Myocardial tissue characteristics(Day 1)
- Health economics: Cardiac procedures(0-20 years)
- Health economics: Medication use(0-20 years)
- Within subject change in myocardial blood flow(0-12 months)
- Health Status: Duke Activity Status Index(0-36 months)
- Health Status: Montreal Cognitive Assessment (MOCA)(0-36 months)
- Health Outcomes: Major Adverse Cardiovascular Events(0-20 years)
- Brain small vessel disease(0-36 months)
- Correlation between small vessel disease in the brain and myocardial perfusion(0-36 months)
- Long term prognosis(0-20 years)
- Health economics: Inpatients visits(0-20 years)
- Work limitation(0-36 months)
研究者
Colin Berry
Chief Investigator
NHS National Waiting Times Centre Board