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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01946087
First received: September 4, 2013
Last updated: November 19, 2016
Last verified: November 2016
  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 Blind (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 4, 2013
Last Updated: November 19, 2016

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

ClinicalTrials.gov processed this record on March 24, 2017