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

July 13, 2009
October 31, 2012
July 2009
August 2012   (final data collection date for primary outcome measure)
The dichotomous rate of complete ST-segment resolution (STR) [ Time Frame: at 30 minutes after final contrast injection ] [ Designated as safety issue: No ]
The dichotomous rate of complete ST-segment resolution (STR) [ Time Frame: at 30 minutes after last contrast injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942500 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Left ventricular ejection fraction on echocardiography [ Time Frame: at 6 months after index PCI ] [ Designated as safety issue: No ]
  • All Death, Cardiac death, Myocardial infarction (MI), Target vessel revascularization (TVR), Target lesion revascularization (TLR), and composite of death, MI, and TVR [ 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 ]
Not Provided
Not Provided
 
Effects of Postconditioning On Myocardial Reperfusion
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myocardial Reperfusion
  • Myocardial Infarction
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.
  • Experimental: Post-conditioning
    Intervention: Procedure: Post-conditioning
  • No Intervention: Conventional primary PCI
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00942500
2009-02-007
Yes
Hyeon-Cheol Gwon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
Samsung Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP