Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction: The CRM-OAT Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in LV end-systolic volume
研究概览
简要总结
Patients with STEMI are usually treated with primary PCI in contemporary practice. However, primary PCI is currently deemed unbeneficial or potentially harmful in patients presenting late after a STEMI. There is limited data to suggest that patients who may have viable myocardium despite presenting late with a STEMI may derive benefit from PCI, which may be denied in current practice. CMR imaging is the reference modality for assessment of left ventricular function and myocardial viability. This feasibility study will randomise late presenting STEMI patients with CMR documented viability to PCI plus optimal medical therapy (OMT) versus OMT alone. The investigator hypothesises that PCI in this cohort will improve left ventricular remodelling and function. Favourable results will lead to an adequately powered multi-centre trial with the potential to improve the management of late resenting STEMI patients and impact on clinical practice guidelines.
详细描述
Stable patients with late presenting STEMI will be prospectively recruited into this study from 5 large primary PCI centres in the UK. Ethical approval from a Research Ethics Committee and written informed consent from all participants will be obtained.
Recruited patients will receive baseline CMR to detect viability within 7 days of index admission or coronary angiogram. Patients with non-viable myocardium will be treated with standard clinical care and form part of the registry arm. Patients with viable myocardium will be randomised to revascularization with OMT vs OMT alone. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will recieve dual anti-platelet treatment for 12 months, or as per local practice guidelines. other treatments will be given according to evidence based guidelines. Revascularization wth CABG can also be considered, based on MDT decision.
The feasibility study will randomise 60 patients (30 in PCI and 30 in OMT group). OAT-NUC trial showed that 70% late presenting STEMI may have viability. therefor, recruiting 90 patients for baseline CMR may provide 60 patients to randomise. the results of this feasibility study will inform the investigator of the numbers needed for an adequately powered multi-centre clinical trial.
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
- •STEMI patients presenting >12 hours, and within 28 days, after symptom onsent.
- •Stable patients with no on-going features of ischaemia (chest pain, dynamic ECG changes)
排除标准
- •Inability to give informed consent
- •Standard CMR contra-indications
- •Haemodynamic instability (requiring on-going intravenous therapy or respiratory support)
- •Previous coronary artery bypass grafting and cardiomyopathy
- •Estimated glomerular filtration rate <30ml/min/1.73m2
- •End-stage malignancy or expected life expectancy of less than 12 months.
结局指标
主要结局
Change in LV end-systolic volume
时间窗: from baseline to 3-months
Change in LV end-systolic volume from baseline to 3-month CMR.
次要结局
未报告次要终点