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Effects of Postconditioning On Myocardial Reperfusion (POST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942500
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

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.

Condition or disease Intervention/treatment
Myocardial Reperfusion Myocardial Infarction Procedure: Post-conditioning

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
Study Start Date : July 2009
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Post-conditioning Procedure: 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.
No Intervention: Conventional primary PCI

Primary Outcome Measures :
  1. The dichotomous rate of complete ST-segment resolution (STR) [ Time Frame: at 30 minutes after final contrast injection ]

Secondary Outcome Measures :
  1. Myocardial blush grade [ Time Frame: within 10 minutes after PCI ]
  2. Thrombolysis in Myocardial Infarction (TIMI) flow grade [ Time Frame: within 10 minutes after PCI ]
  3. Angiographic no-reflow [ Time Frame: during PCI ]
  4. All death [ Time Frame: at 30 days and 1 year ]
  5. Stent thrombosis [ Time Frame: at 30 days and 1 year ]
  6. Cardiac death [ Time Frame: at 30 days and 1 year ]
  7. Myocardial infarction [ Time Frame: at 30 days and 1 year ]
  8. Severe heart failure [ Time Frame: at 30 days and 1 year ]
    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.

  9. Target vessel revascularization (TVR) [ Time Frame: at 30 days and 1 year ]
  10. Composite of death, MI, severe heart failure, or stent thrombosis [ Time Frame: at 30 days and 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00942500

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center Identifier: NCT00942500     History of Changes
Other Study ID Numbers: 2009-02-007
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
ST-elevation myocardial infarction
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases