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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Beta Blockers Carvedilol Phosphate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring remote ischemic conditioning, beta-blocker

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Beta Blockers Carvedilol Phosphate

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2017
Last Updated
February 19, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03169426
Brief Title
Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
Official Title
Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
remote ischemic conditioning, beta-blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beta Blockers Carvedilol Phosphate
Arm Type
Experimental
Arm Description
Subjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning. Intervention: taking beta-blocker
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects are going to undergo remote ischemic conditioning without taking any drug.
Intervention Type
Drug
Intervention Name(s)
Beta Blockers Carvedilol Phosphate
Intervention Description
Subjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
24 hour after remote ischemic conditioning to healthy volunteers

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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