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Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury (RIPC)

Primary Purpose

Myocardial Injury

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
delayed remote ischemic preconditioning
control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Injury focused on measuring delayed remote ischemic preconditioning, troponin, valve replacement surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 80 years of adult patient undergoing cardiac valve surgery

Exclusion Criteria:

  • Patient who did not agree to the study
  • Emergency operation
  • Using inotropics, mechanical assisting device
  • Severe liver disease (>Child class II )
  • Severe renal disease (Renal replacement therapy)
  • left ventricular ejection fraction < 30%
  • Co-operation of major surgery (Carotid endarterectomy )
  • Oral hypoglycemic agent (Sulfonylurea, Glibenclamide)
  • peripheral vascular disease affecting upper extremity

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

delayed remote ischemic preconditioning

control

Arm Description

applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times)

All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.

Outcomes

Primary Outcome Measures

Troponin I change

Secondary Outcome Measures

serum creatinine changes

Full Information

First Posted
July 1, 2013
Last Updated
June 7, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01903161
Brief Title
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury
Acronym
RIPC
Official Title
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury in Patients Undergoing Cardiac Valve Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in patients undergoing cardiac valve replacement surgery.
Detailed Description
Ischemic preconditioning is one of the strategies that can reduce perioperative myocardial injury. It is a concept that briefly induced ischemia and reperfusion before the myocardial injury can reduce the myocardial injury. But it is difficult to apply ischemic preconditioning in operative field, because cross-clamping of aorta or coronary artery is difficult and invasive. Afterward concept of remote ischemic preconditioning(RIPC) has introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant myocardial injury. It is known that myocardial protective effect of ischemic preconditioning have biphasic pattern. Early protective effect wanes after a few hours, then recurs after 24-48 hours, and can persist for up to 3-4 days. It is called second window of preconditioning or delayed ischemic preconditioning. Delayed ischemic preconditioning is similar to early ischemic preconditioning in mechanism but it is different that it produces protein that can mediate myocardial protection effect. Unlike ischemic preconditioning, it is little known about delayed effect of RIPC. RIPC can be done by applying compression cuff on upper or lower extremities and it is noninvasive and easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery clamping. Delayed ischemic preconditioning is performed one day before the surgery, and it is safe and easy to apply RIPC in a clinical setting. And in this study investigators are going to evaluate cardioprotective effect of delayed RIPC. Myocardial injury can be predicted by elevation of cardiac enzyme. Investigators are going to perform RIPC one day before the valve replacement surgery and compare troponin I with control group to assess cardioprotective effect of delayed RIPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Injury
Keywords
delayed remote ischemic preconditioning, troponin, valve replacement surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
delayed remote ischemic preconditioning
Arm Type
Experimental
Arm Description
applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times)
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Intervention Type
Procedure
Intervention Name(s)
delayed remote ischemic preconditioning
Intervention Description
In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Primary Outcome Measure Information:
Title
Troponin I change
Time Frame
before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours
Secondary Outcome Measure Information:
Title
serum creatinine changes
Time Frame
before induction of anesthesia, postoperative 1, 3, 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 80 years of adult patient undergoing cardiac valve surgery Exclusion Criteria: Patient who did not agree to the study Emergency operation Using inotropics, mechanical assisting device Severe liver disease (>Child class II ) Severe renal disease (Renal replacement therapy) left ventricular ejection fraction < 30% Co-operation of major surgery (Carotid endarterectomy ) Oral hypoglycemic agent (Sulfonylurea, Glibenclamide) peripheral vascular disease affecting upper extremity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deok Man Hong, M.D., Ph. D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tae Kyong Kim, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury

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