NCT01078272终止不适用
The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
St. Francis Hospital, New York2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- MACE
研究概览
简要总结
This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm will improve results of coronary stent implantation by:
- reducing chest pain and electrocardiogram changes during balloon inflation to place the stent
- reducing leakage of heart muscle protein(troponin) into the blood stream after stent placement, indicated reduced damage to heart muscle during stent implantation
- increases in molecules in the blood that promote dilation of arteries
- reduced evidence of heart muscle damage on MRI immediately after stenting
- improved patient outcomes over six months with fewer adverse cardiovascular events(heart attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death, stroke, transient ischemic attack)
- improved heart structure and function at 6 months after stenting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.
排除标准
- •Recent (1 month) myocardial infarction
- •Acute coronary syndrome
- •Chest pain at res
- •Estimated glomerular filtration rate(GFR)<45 mL/min/1.73 m2
- •Frequent premature atrial or ventricular contractions or atrial fibrillation
- •Any contraindication to MRI including implanted non MRI compatible medical devices or ferromagnetic materials such as shrapnel
- •Inability to breath-hold
- •Severe claustrophobia
- •Persistent tremor
- •Inability to follow instructions.
结局指标
主要结局
MACE
时间窗: 6 months post-stenting
MACE is defined as a combined endpoint including: heart attack, acute coronary syndrome,restenosis of the stented artery, new heart failure stroke, transient ischemic attack or death
次要结局
- troponin I(24 hours)
- chest pain during stenting(immediate during procedure)
- ST segment changes during stent implantation(immediate)
- MRI delayed enhancement(1-7 days after stenting)
- Late left ventricular volumes and ejection fraction(6 months)
研究者
Nathaniel Reichek MD
Director, Research Department and Cardiac Imaging Program
St. Francis Hospital, New York
研究点 (2)
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