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OpenTrials
Completed

NCT Number: NCT01946087

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

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

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Key information

Conditions

Patients With Elective Aortic Valve Replacement Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Remote ischemic preconditioning at left upper arm

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

Procedure

keeping the cuff deflated

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2013
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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