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Completed

NCT Number: NCT00942500

Effects of Postconditioning On Myocardial Reperfusion

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

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Key information

Conditions

Myocardial Reperfusion Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
  • 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

Treatment and study plan

Post-conditioning

Procedure

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.

Primary outcomes

  1. The dichotomous rate of complete ST-segment resolution (STR)

    Time frame: at 30 minutes after final contrast injection

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction

Acronym: POST

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2009
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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