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

NCT ID: NCT01946087

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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Conditions

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Patients With Elective Aortic Valve Replacement

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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RIPC group

Group Type EXPERIMENTAL

Remote ischemic preconditioning at left upper arm

Intervention Type PROCEDURE

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)

Control group

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type PROCEDURE

keeping the cuff deflated

Interventions

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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)

Intervention Type PROCEDURE

Control group

keeping the cuff deflated

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0283

Identifier Type: -

Identifier Source: org_study_id