Chronic Remote Ischemic Conditioning to Modify Post-MI Remodeling (CRIC-RCT)
Chronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5B 1W8
- 招聘中
- St. Michael's Hospital
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接触:
- Niel Fam, RCPSC
- 电话号码:416-864-5466
- 邮箱:famn@smh.ca
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Toronto、Ontario、加拿大、M4N 3M5
- 招聘中
- Sunnybrook Health Sciences Centre
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接触:
- Harindra Wijeysundera, MD, PhD
- 电话号码:416-480-4527
- 邮箱:harindra.wijeysundera@sunnybrook.ca
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Toronto、Ontario、加拿大、M5G 2C4
- 招聘中
- University Health Network, Toronto General Hospital
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首席研究员:
- Chris Overgaard, RCPSC
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副研究员:
- Vladimir Dzavik, FRCPC, MD
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副研究员:
- Andrew Crean, MSc, FRCR
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副研究员:
- Michael Farkouh, MD, MSc
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
(i) Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; (ii) Antegrade TIMI 0 or 1 prior to PCI; (iii) Age ≥18 years; (iv) Informed consent from patient or next of kin.
Exclusion Criteria:
(i) Known history of diabetes; (ii) Coronary anatomy warranting emergent coronary artery bypass graft surgery; (iii) Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); (iv) Need for hemodialysis; (v) Malignancy, HIV, or central nervous system disorder; (vi) Cardiopulmonary resuscitation >15 min and compromised level of consciousness; (vii) Cardiogenic shock; (viii) Current participation in any research study involving investigational drugs or devices; (ix) Inability to safely undergo cMRI
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Chronic Remote Ischemic Conditioning
Remote ischemic conditioning will be induced using an AutoRIC device (occluding arm bloodflow exactly like manual bloodpressure cuff).
With the participant in a supine or seated upright position, the AutoRIC device will be placed on the right arm and will inflate to a pressure of 200mmHg for 5 minutes (ischemia).
The device will then auto-deflate (reperfusion), completing one cycle of ischemia-reperfusion.
A total of 4 inflation and deflation cycles will occur.
This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
|
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假比较器:SHAM Remote Ischemic Conditioning
Sham conditioning will involve the AutoRIC device being placed on the right arm and will inflate to a pressure of 10mmHg for 5 minutes (ie.
no limb ischemia will occur).
The device will then auto-deflate, completing one cycle.
A total of 4 inflation and deflation cycles will occur.
This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in LVEDV from baseline
大体时间:28 days post-surgery
|
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 28 days post-PCI by cardiac MRI.
|
28 days post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
change in LVESV from baseline
大体时间:28 days post-surgery
|
change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 28 days post-PCI by cardiac MRI
|
28 days post-surgery
|
合作者和调查者
调查人员
- 首席研究员:Andrew Redington, FRCPC、The Hospital for Sick Children
- 首席研究员:Christopher Overgaard, RCPSC、University Health Network, Toronto General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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