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CompletedNCT01946087Updated Nov 22, 2016

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

A Phase 4 interventional study of Remote ischemic preconditioning at left upper arm and Control group in Patients With Elective Aortic Valve Replacement, sponsored by Yonsei University. Completed at 1 site in South Korea. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Yonsei University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium

02

Conditions studied

  • Patients With Elective Aortic Valve Replacement

Keywords

  • Remote ischemic preconditioning
  • cardiac surgery
  • left ventricular hypertrophy
  • reperfusion injury salvage kinase
03

In context

Hypertrophy, Left Ventricular

125 studies on the registry are indexed under Hypertrophy, Left Ventricular; 24 are open to participants now.

This study's enrollment of 79 is below the median of 120 across 73 interventional studies indexed under Hypertrophy, Left Ventricular.

Browse Hypertrophy, Left Ventricular studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • diabetes mellitus,
  • coronary stenosis ≥70%,
  • renal failure (serum creatinine > 2.0 mg/dL),
  • upper arm peripheral vascular disease,
  • LV ejection fraction \<50%
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    RIPC group

    Procedure: Remote ischemic preconditioning at left upper arm

  • Placebo comparator
    Control group

    Procedure: Control group

Interventions

  • ProcedureRemote 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)

  • ProcedureControl group

    keeping the cuff deflated

06

What researchers measure

Primary outcomes

  1. Serum levels of CK-MB and Tn-T

    Time frame: baseline

  2. Serum levels of CK-MB and Tn-T

    Time frame: 12-hour after surgery

  3. Serum levels of CK-MB and Tn-T

    Time frame: 24-hour after surgery

Secondary outcomes

  1. Myocardial activation of protective signaling pathway

    Time frame: Before commencement of CPB

  2. Myocardial activation of protective signaling pathway

    Time frame: After taking off CPB

07

Study locations

1 site
  • Yonsei University College of Medicine
    Seoul, 120-752, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01946087
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 19, 2013
Start date
Jun 2013
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Nov 22, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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