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Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01946087
First Posted: September 19, 2013
Last Update Posted: November 22, 2016
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.
Information provided by (Responsible Party):
Yonsei University
  Purpose
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium

Condition Intervention Phase
Patients With Elective Aortic Valve Replacement Procedure: Remote ischemic preconditioning at left upper arm Procedure: Control group Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Serum levels of CK-MB and Tn-T [ Time Frame: baseline ]
  • Serum levels of CK-MB and Tn-T [ Time Frame: 12-hour after surgery ]
  • Serum levels of CK-MB and Tn-T [ Time Frame: 24-hour after surgery ]

Secondary Outcome Measures:
  • Myocardial activation of protective signaling pathway [ Time Frame: Before commencement of CPB ]
  • Myocardial activation of protective signaling pathway [ Time Frame: After taking off CPB ]

Enrollment: 79
Study Start Date: June 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIPC group Procedure: Remote ischemic preconditioning at left upper arm
Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) & 5 min reperfusion (deflation)
Placebo Comparator: Control group Procedure: Control group
keeping the cuff deflated

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR

Exclusion Criteria:

  • diabetes mellitus,
  • coronary stenosis ≥70%,
  • renal failure (serum creatinine > 2.0 mg/dL),
  • upper arm peripheral vascular disease,
  • LV ejection fraction <50%
  Contacts and Locations
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): NCT01946087


Locations
Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01946087     History of Changes
Other Study ID Numbers: 4-2012-0283
First Submitted: September 4, 2013
First Posted: September 19, 2013
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Yonsei University:
Remote ischemic preconditioning
cardiac surgery
left ventricular hypertrophy
reperfusion injury salvage kinase