Clinical trial NCT00942500: Effects of Postconditioning On Myocardial Reperfusion
Official title: Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Reperfusion
Myocardial Infarction
Keywords: Post-conditioning
ST-elevation myocardial infarction
Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

  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

Primary outcomes:
measure: The dichotomous rate of complete ST-segment resolution (STR)
timeFrame: at 30 minutes after final contrast injection
Secondary outcomes:
measure: Myocardial blush grade
timeFrame: within 10 minutes after PCI
measure: Thrombolysis in Myocardial Infarction (TIMI) flow grade
timeFrame: within 10 minutes after PCI
measure: Angiographic no-reflow
timeFrame: during PCI
measure: All death
timeFrame: at 30 days and 1 year
measure: Stent thrombosis
timeFrame: at 30 days and 1 year
measure: Cardiac death
timeFrame: at 30 days and 1 year
measure: Myocardial infarction
timeFrame: at 30 days and 1 year
measure: Severe heart failure
timeFrame: at 30 days and 1 year
measure: Target vessel revascularization (TVR)
timeFrame: at 30 days and 1 year
measure: Composite of death, MI, severe heart failure, or stent thrombosis
timeFrame: at 30 days and 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.