Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
November 19, 2016 updated by: Yonsei University
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Yonsei University College of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
|
keeping the cuff deflated
|
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Experimental: RIPC group
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum levels of CK-MB and Tn-T
Time Frame: baseline
|
baseline
|
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Serum levels of CK-MB and Tn-T
Time Frame: 12-hour after surgery
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12-hour after surgery
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Serum levels of CK-MB and Tn-T
Time Frame: 24-hour after surgery
|
24-hour after surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myocardial activation of protective signaling pathway
Time Frame: Before commencement of CPB
|
Before commencement of CPB
|
|
Myocardial activation of protective signaling pathway
Time Frame: After taking off CPB
|
After taking off CPB
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
September 4, 2013
First Submitted That Met QC Criteria
September 16, 2013
First Posted (Estimate)
September 19, 2013
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 19, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2012-0283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.