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临床试验/NCT03169426
NCT03169426已完成4 期

Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
11
试验地点
1
主要终点
Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers

研究概览

简要总结

Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.

详细描述

This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male volunteer
  • Not taking any medication

排除标准

  • BMI < 18 kg/m2 or > 30 kg/m2
  • Allergic history of any medication
  • Baseline SBP > 150 mmHg or < 100 mmHg
  • Baseline DBP > 100 mmHg or < 50 mmHg
  • Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
  • Cannot undergoing remote ischemic conditioning for any reason
  • Refuse to enroll

研究组 & 干预措施

Beta Blockers Carvedilol Phosphate

Experimental

Subjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning.

Intervention: taking beta-blocker

干预措施: Beta Blockers Carvedilol Phosphate (Drug)

结局指标

主要结局

Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers

时间窗: 24 hour after remote ischemic conditioning to healthy volunteers

Infarct size measurement after perfusing the rat heart with human serum-derived dialysate and comparison before and after remote ischemic conditioning performed to healthy volunteers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunseok Jeon

Professor

Seoul National University Hospital

研究点 (1)

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