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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 22, 2014