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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169426
• Other study ID #: BB_RIPC
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2017
• Last updated: February 19, 2018
• Start date: May 17, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Beta Blockers Carvedilol Phosphate
Subjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	24 hour after remote ischemic conditioning to healthy volunteers