The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- serum level of high sensitive troponin at several timepoints
研究概览
简要总结
Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin levels. The underlying mechanism is not yet elucidated, but could be explained by changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion injury. If the mechanism underlying the troponin release during exercise is similar to that of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding RIPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-45 year
- •willing to sign informed consent
排除标准
- •hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg)
- •any cardiovascular abnormality in past medical history, physical examination or ECG, including QTc interval
- •drug abuse
- •alcohol abuse (> 3 units/day)
- •smoking during the last 2 years
- •BMI >30 kg/m2
- •inability to perform bicycle test
- •the presence of an absolute or relative contra-indication for exercise (table 2 in protocol)
- •the presence of diabetes (fasting glucose > 6.9 mmol/L, non-fasting glucose >11.0 mmol/L; if non-fasting glucose is > 6.9 mmol/L, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/L)
- •total cholesterol in blood 6.6 mmol/L or higher
结局指标
主要结局
serum level of high sensitive troponin at several timepoints
时间窗: timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise
serum level of high sensitive troponin in response to intensive exercise test with or without RIPC at several timepoints
次要结局
未报告次要终点