ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02149316
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemic Reperfusion Injury End Stage Heart Disease Heart Failure Cardiomyopathy Procedure: RIPC+RIPostC Procedure: control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery
Study Start Date : February 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Sham Comparator: control Procedure: control
a deflated cuff placed on the right upper arm




Primary Outcome Measures :
  1. serum cardiac troponin I (cTnI) [ Time Frame: within 72 hours after aortic declamping ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149316


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

Responsible Party: Guyan Wang, The Chief of Infection-Control Department, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT02149316     History of Changes
Other Study ID Numbers: FW2012-863B-C
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiomyopathies
Reperfusion Injury
Myocardial Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Postoperative Complications
Myocardial Ischemia