Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery
Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 26, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedDecember 23, 2016
December 1, 2016
2 years
May 26, 2014
December 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
serum cardiac troponin I (cTnI)
within 72 hours after aortic declamping
Secondary Outcomes (2)
plasma microRNA-133b (miR-133b)
within 72 hours after aortic declamping
plasma microRNA-208a (miR-208a)
within 72 hours after aortic declamping
Study Arms (2)
RIPC+RIPostC
EXPERIMENTALcontrol
SHAM COMPARATORInterventions
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)
Eligibility Criteria
You may qualify if:
- scheduled for elective orthotopic heart transplantation surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guyan Wang, PhD
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Chief of Infection-Control Department
Study Record Dates
First Submitted
May 26, 2014
First Posted
May 29, 2014
Study Start
February 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
December 23, 2016
Record last verified: 2016-12