Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

December 22, 2016 updated by: Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery

The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • China
      • Beijing, China, 100037
        • State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC

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

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for elective orthotopic heart transplantation surgery

Exclusion Criteria:

  • peripheral vascular disease affecting the upper arms
  • mechanical circulatory support before surgery
  • taking the antidiabetic sulphonylurea, glibenclamide
  • cold ischemic time of donor heart > 12 hours
  • repeated heart surgery

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control
Procedure: control
a deflated cuff placed on the right upper arm
Experimental: RIPC+RIPostC
Procedure: RIPC+RIPostC
Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum cardiac troponin I (cTnI)
Time Frame: within 72 hours after aortic declamping
within 72 hours after aortic declamping

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma microRNA-133b (miR-133b)
Time Frame: within 72 hours after aortic declamping
within 72 hours after aortic declamping
plasma microRNA-208a (miR-208a)
Time Frame: within 72 hours after aortic declamping
within 72 hours after aortic declamping

Collaborators and Investigators

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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Guyan Wang, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China

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

February 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FW2012-863B-C

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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