Effects of Postconditioning On Myocardial Reperfusion (POST)
October 31, 2012 updated by: Hyeon-Cheol Gwon, Samsung Medical Center
Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
700
Phase
- Not Applicable
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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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria General 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
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in at least 2 contiguous leads
Angiographic Inclusion Criteria
- 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
General 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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Post-conditioning
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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.
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No Intervention: Conventional primary PCI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The dichotomous rate of complete ST-segment resolution (STR)
Time Frame: at 30 minutes after final contrast injection
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at 30 minutes after final contrast injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Myocardial blush grade
Time Frame: within 10 minutes after PCI
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within 10 minutes after PCI
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Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame: within 10 minutes after PCI
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within 10 minutes after PCI
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Angiographic no-reflow
Time Frame: during PCI
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during PCI
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All death
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Stent thrombosis
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Cardiac death
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Myocardial infarction
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Severe heart failure
Time Frame: at 30 days and 1 year
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Severe heart failure was defined as heart failure with documented arterial partial pressure of oxygen less than 60 mmHg or with pulmonary edema documented radiographically or requiring intubation, 100% oxygen, or insertion of a mechanical support device.
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at 30 days and 1 year
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Target vessel revascularization (TVR)
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Composite of death, MI, severe heart failure, or stent thrombosis
Time Frame: at 30 days and 1 year
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at 30 days and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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
July 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 13, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (Estimate)
July 21, 2009
Study Record Updates
Last Update Posted (Estimate)
November 1, 2012
Last Update Submitted That Met QC Criteria
October 31, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-02-007
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