Effects of Postconditioning On Myocardial Reperfusion

NCT ID: NCT00942500

Last Updated: 2012-11-01

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

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.

Detailed Description

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Conditions

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Myocardial Reperfusion Myocardial Infarction

Keywords

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Post-conditioning ST-elevation myocardial infarction Angioplasty, Transluminal, Percutaneous Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Post-conditioning

Group Type EXPERIMENTAL

Post-conditioning

Intervention Type PROCEDURE

Coronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade \<2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade ≥2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained ≥30%, stent will be deployed.

Conventional primary PCI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Post-conditioning

Coronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade \<2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade ≥2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained ≥30%, stent will be deployed.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject must be at least 18 years of age.
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Diagnosis of STEMI

1. presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
2. ST-segment elevation more than 1 mm in at least 2 contiguous leads


* Target lesion(s) must be located in a native coronary artery
* Target lesion(s) must be amenable for percutaneous coronary intervention
* TIMI flow grade of infarct related arteries \<2

Exclusion Criteria

* Patients with hemodynamic instability or those with cardiogenic shock
* Target lesion is located in left main stem
* Rescue PCI after thrombolysis or facilitated PCI
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyeon-Cheol Gwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyeon-Cheol Gwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hahn JY, Yu CW, Park HS, Song YB, Kim EK, Lee HJ, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Lim DS, Gwon HC. Long-term effects of ischemic postconditioning on clinical outcomes: 1-year follow-up of the POST randomized trial. Am Heart J. 2015 May;169(5):639-46. doi: 10.1016/j.ahj.2015.01.015. Epub 2015 Feb 27.

Reference Type DERIVED
PMID: 25965711 (View on PubMed)

Kim EK, Hahn JY, Song YB, Lee SC, Choi JH, Choi SH, Lee SH, Choe YH, Gwon HC. Effect of ischemic postconditioning on myocardial salvage in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the POST randomized trial. Int J Cardiovasc Imaging. 2015 Mar;31(3):629-37. doi: 10.1007/s10554-015-0589-y. Epub 2015 Jan 15.

Reference Type DERIVED
PMID: 25589306 (View on PubMed)

Hahn JY, Song YB, Kim EK, Yu CW, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Park HS, Lim DS, Gwon HC. Ischemic postconditioning during primary percutaneous coronary intervention: the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (POST) randomized trial. Circulation. 2013 Oct 22;128(17):1889-96. doi: 10.1161/CIRCULATIONAHA.113.001690. Epub 2013 Sep 25.

Reference Type DERIVED
PMID: 24068776 (View on PubMed)

Other Identifiers

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2009-02-007

Identifier Type: -

Identifier Source: org_study_id