Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery

November 19, 2016 updated by: Yonsei University
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR

Exclusion Criteria:

  • diabetes mellitus,
  • coronary stenosis ≥70%,
  • renal failure (serum creatinine > 2.0 mg/dL),
  • upper arm peripheral vascular disease,
  • LV ejection fraction <50%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Procedure: Control group
keeping the cuff deflated
Experimental: RIPC group
Procedure: Remote ischemic preconditioning at left upper arm
Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) & 5 min reperfusion (deflation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum levels of CK-MB and Tn-T
Time Frame: baseline
baseline
Serum levels of CK-MB and Tn-T
Time Frame: 12-hour after surgery
12-hour after surgery
Serum levels of CK-MB and Tn-T
Time Frame: 24-hour after surgery
24-hour after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial activation of protective signaling pathway
Time Frame: Before commencement of CPB
Before commencement of CPB
Myocardial activation of protective signaling pathway
Time Frame: After taking off CPB
After taking off CPB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 19, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2012-0283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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