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Completed

NCT Number: NCT02149316

Remote Ischemic Preconditioning With Postconditioning 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.

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Key information

Conditions

Myocardial Ischemic Reperfusion Injury Cardiomyopathies Cardiomyopathy Cardiovascular Diseases End Stage Heart Disease Heart Diseases Heart Failure Myocardial Ischemia Myocardial Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIPC+RIPostC

Procedure

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)

Control

Procedure

a deflated cuff placed on the right upper arm

Primary outcomes

  1. serum cardiac troponin I (cTnI)

    Time frame: within 72 hours after aortic declamping

Secondary outcomes

  1. plasma microRNA-133b (miR-133b)

    Time frame: within 72 hours after aortic declamping

  2. plasma microRNA-208a (miR-208a)

    Time frame: within 72 hours after aortic declamping

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 29, 2014
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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