The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean change in LVEF from baseline to 4 months as assessed by cMRI
研究概览
简要总结
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •LVEF < 45% on baseline ECHO
- •First STEMI
- •Successful revascularisation by PPCI
- •Able to attend regional centre for follow-up appointment
- •Competent to consent
排除标准
- •< 18 of age
- •ICD or CRTP/D in-situ
- •Prior history of heart failure
- •Haemoglobin < 11.5 g/dl
- •Creatinine > 200 µmol/L (eGFR<30ml/min/m2)
- •Known malignancy/other comorbid condition which in the opinion of the investigator is likely to have significant negative influence on life expectancy
- •Significant complications/illness following MI
- •Unable to undergo cMRI
- •Further planned coronary interventions
- •Enrollment in another clinical trial
结局指标
主要结局
Mean change in LVEF from baseline to 4 months as assessed by cMRI
时间窗: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.
Mean change in LVEF from baseline to 4 months as assessed by cMRI
次要结局
- Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months(Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI.)
- Final infarct size at 4 months as assessed by cMRI(Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.)
- Mean KCCQ score at 4 months(Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.)