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Effects of Postconditioning On Myocardial Reperfusion (POST)

Primary Purpose

Myocardial Reperfusion, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Post-conditioning
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion focused on measuring Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Post-conditioning

Conventional primary PCI

Arm Description

Outcomes

Primary Outcome Measures

The dichotomous rate of complete ST-segment resolution (STR)

Secondary Outcome Measures

Myocardial blush grade
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Angiographic no-reflow
All death
Stent thrombosis
Cardiac death
Myocardial infarction
Severe heart failure
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.
Target vessel revascularization (TVR)
Composite of death, MI, severe heart failure, or stent thrombosis

Full Information

First Posted
July 13, 2009
Last Updated
October 31, 2012
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00942500
Brief Title
Effects of Postconditioning On Myocardial Reperfusion
Acronym
POST
Official Title
Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion, Myocardial Infarction
Keywords
Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-conditioning
Arm Type
Experimental
Arm Title
Conventional primary PCI
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Post-conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
The dichotomous rate of complete ST-segment resolution (STR)
Time Frame
at 30 minutes after final contrast injection
Secondary Outcome Measure Information:
Title
Myocardial blush grade
Time Frame
within 10 minutes after PCI
Title
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame
within 10 minutes after PCI
Title
Angiographic no-reflow
Time Frame
during PCI
Title
All death
Time Frame
at 30 days and 1 year
Title
Stent thrombosis
Time Frame
at 30 days and 1 year
Title
Cardiac death
Time Frame
at 30 days and 1 year
Title
Myocardial infarction
Time Frame
at 30 days and 1 year
Title
Severe heart failure
Description
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.
Time Frame
at 30 days and 1 year
Title
Target vessel revascularization (TVR)
Time Frame
at 30 days and 1 year
Title
Composite of death, MI, severe heart failure, or stent thrombosis
Time Frame
at 30 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25965711
Citation
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.
Results Reference
derived
PubMed Identifier
25589306
Citation
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.
Results Reference
derived
PubMed Identifier
24068776
Citation
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.
Results Reference
derived

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Effects of Postconditioning On Myocardial Reperfusion

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