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

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Beta Blockers Carvedilol Phosphate

• Registration Number: NCT03169426
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-16
• Study Start: 2017-05-17
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-30
• Primary Completion: 2017-11-10
• Study Completion: 2017-11-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Healthy male volunteer
• Not taking any medication

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta Blockers Carvedilol Phosphate	Beta Blockers Carvedilol Phosphate	Subjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning. Intervention: taking beta-blocker

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of