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

NCT03169426 | Completed Phase 4 DMC

• 1 other identifier: BB_RIPC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

remote ischemic conditioning; beta-blocker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Beta Blockers Carvedilol Phosphate

Control

NO INTERVENTION

Subjects are going to undergo remote ischemic conditioning without taking any drug.

Interventions

Beta Blockers Carvedilol Phosphate DRUG

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

Beta Blockers Carvedilol Phosphate

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteer
• Not taking any medication

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 30, 2017
• Study Start: May 17, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)