ACCELERATE-CMR: Accelerated Cardiovascular Magnetic Resonance for the Detection of Coronary Artery Disease - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,022
- 主要终点
- Composite clinical endpoint
研究概览
简要总结
Coronary heart disease occurs when the blood vessels that supply the heart become narrowed or blocked. It is a leading cause of illness and death in the UK. Accurate diagnosis is important because effective treatments are available, but current tests are invasive, uncomfortable, and carry some risks.
Cardiovascular magnetic resonance (CMR), also known as a heart MRI scan, is a safe and accurate test for diagnosing coronary heart disease. However, access to CMR is limited because standard scans take around 45 to 50 minutes, restricting the number of patients who can be scanned.
Researchers have developed a faster CMR scan that takes only 15 to 20 minutes. Previous studies suggest that this shorter scan provides similar accuracy to the standard scan while improving patient comfort.
This study will recruit 2022 adults with suspected coronary heart disease from hospitals in the UK. Participants will be randomly assigned to receive either the standard CMR scan or the faster CMR scan.
The study will compare whether the accelerated scan provides similar clinical outcomes to the standard scan and whether patients prefer it. If successful, the accelerated scan could increase access to CMR by allowing more patients to be scanned each day, and enabling more efficient use of NHS resources.
详细描述
Background and clinical context Coronary artery disease (CAD) remains one of the leading causes of morbidity and mortality worldwide and is responsible for a substantial burden of healthcare utilisation. Appropriate management depends upon accurately identifying patients with clinically significant disease while avoiding unnecessary invasive investigation in those without functionally important coronary artery disease. Consequently, contemporary clinical guidelines recommend non-invasive imaging as the initial investigation for many patients with suspected chronic coronary syndromes before consideration of invasive coronary angiography (ICA).
Although ICA remains the reference standard for defining coronary anatomy, it is invasive, costly, exposes patients to ionising radiation and carries a small but important risk of complications. Furthermore, anatomical stenosis alone does not reliably indicate whether a lesion causes myocardial ischaemia, and a substantial proportion of patients undergoing ICA do not subsequently require coronary revascularisation. These limitations have driven a shift towards non-invasive imaging strategies that more appropriately select patients for invasive investigation.
Stress cardiovascular magnetic resonance (CMR) has become an established non-invasive imaging modality for the assessment of suspected CAD. It combines assessment of myocardial perfusion, ventricular function and myocardial scar within a single examination without exposure to ionising radiation, allowing comprehensive evaluation of both ischaemic heart disease and alternative cardiac pathology. Multiple prospective studies and randomised trials have demonstrated excellent diagnostic performance and have established stress CMR as an effective gatekeeper to ICA, reducing unnecessary invasive procedures while maintaining excellent clinical outcomes.
Despite these advantages, access to stress CMR remains limited by finite scanner capacity and prolonged examination times. Conventional stress CMR protocols typically require 45-60 minutes, limiting scanner throughput and contributing to prolonged waiting times in many healthcare systems. Expansion of CMR capacity through additional scanners and workforce growth is resource intensive, highlighting the need for more efficient use of existing imaging infrastructure.
Recent advances in pulse sequence design, accelerated image acquisition and streamlined workflow have created an opportunity to redesign stress CMR examinations while preserving the diagnostic information required for routine clinical decision making. Rather than simply accelerating individual imaging sequences, these developments allow optimisation of the entire imaging pathway using contemporary real-time cine imaging, streamlined late gadolinium enhancement imaging and stress perfusion imaging. The resulting accelerated protocol substantially reduces scan duration while maintaining the comprehensive nature of the CMR examination.
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
- 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
- •patients >18 years of age referred for routine clinical stress CMR:
- •A) with chest pain or angina equivalent OR
- •o B) with heart failure/suspected heart failure and referred for diagnosis of suspected CAD or evaluation of heart failure aetiology
- •Willing and able to consent to participate in the trial
排除标准
- •standard exclusion criteria for clinical stress CMR i.e.:
- •absolute contraindications to CMR (non-conditional cardiac implantable electronic devices, metallic implants/foreign bodies),
- •contraindications to adenosine (severe pulmonary disease, sinus-node/high-grade atrioventricular disease)
- •severe kidney dysfunction (estimated glomerular filtration rate [eGFR] <30ml/min/1.73m2)
- •uncontrolled arrhythmia or unstable chest pain
- •severe claustrophobia
- •previous invasive coronary angiography (within 12 months) with normal angiographic assessment and referred for CMR diagnosis of CMD
结局指标
主要结局
Composite clinical endpoint
时间窗: 12 months
Composite of unnecessary invasive coronary angiography, unplanned coronary revascularisation, and additional non-invasive cardiac testing.
次要结局
- Patient acceptability assessed using the MRI Scan Acceptability Theoretical Framework of Acceptability (TFA) Questionnaire(Baseline (immediately following the MRI scan))
- Patient anxiety assessed using the MRI Scan Anxiety Questionnaire (MRI-AQ)(Baseline (immediately following the MRI scan))
- Unnecessary invasive coronary angiography(12 months, 24 months)
- Unplanned coronary revascularisation(12 months, 24 months)
- Additional non-invasive cardiac testing(12 months, 24 months)
- Major adverse cardiovascular events (MACE)(12 months, 24 months)
- Angina symptoms assessed using the Seattle Angina Questionnaire (SAQ)(Baseline, 12 months, 24 months)
- Health-related quality of life assessed using the 12-Item Short Form Health Survey version 2 (SF-12v2)(Baseline, 12 months, 24 months)
- Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)(Baseline, 12 months, 24 months)
- Total NHS healthcare costs(24 months)
- Quality-adjusted life years (QALYs)(24 months)
- Cost-effectiveness of the accelerated stress CMR pathway(24 months)
