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Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

Primary Purpose

Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RIPC+RIPostC
control
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Ischemic Reperfusion Injury

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPC+RIPostC

control

Arm Description

Outcomes

Primary Outcome Measures

serum cardiac troponin I (cTnI)

Secondary Outcome Measures

plasma microRNA-133b (miR-133b)
plasma microRNA-208a (miR-208a)

Full Information

First Posted
May 26, 2014
Last Updated
December 22, 2016
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02149316
Brief Title
Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery
Official Title
Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease, Heart Failure, Cardiomyopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC+RIPostC
Arm Type
Experimental
Arm Title
control
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
RIPC+RIPostC
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
a deflated cuff placed on the right upper arm
Primary Outcome Measure Information:
Title
serum cardiac troponin I (cTnI)
Time Frame
within 72 hours after aortic declamping
Secondary Outcome Measure Information:
Title
plasma microRNA-133b (miR-133b)
Time Frame
within 72 hours after aortic declamping
Title
plasma microRNA-208a (miR-208a)
Time Frame
within 72 hours after aortic declamping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guyan Wang, PhD
Organizational Affiliation
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
City
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

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Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

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