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Effects of Postconditioning On Myocardial Reperfusion (POST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00942500
First received: July 13, 2009
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Myocardial Reperfusion
Myocardial Infarction
 Procedure: Post-conditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The dichotomous rate of complete ST-segment resolution (STR) [ Time Frame: at 30 minutes after final contrast injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial blush grade [ Time Frame: within 10 minutes after PCI ] [ Designated as safety issue: No ]
  • Thrombolysis in Myocardial Infarction (TIMI) flow grade [ Time Frame: within 10 minutes after PCI ] [ Designated as safety issue: No ]
  • Angiographic no-reflow [ Time Frame: during PCI ] [ Designated as safety issue: No ]
  • All death [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Severe heart failure [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: No ]
    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) [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: No ]
  • Composite of death, MI, severe heart failure, or stent thrombosis [ Time Frame: at 30 days and 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 700
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942500

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

No publications provided

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00942500     History of Changes
Other Study ID Numbers: 2009-02-007
Study First Received: July 13, 2009
Last Updated: October 31, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Post-conditioning
ST-elevation myocardial infarction
Angioplasty, Transluminal, Percutaneous Coronary

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

ClinicalTrials.gov processed this record on June 18, 2013