Effects of Postconditioning On Myocardial Reperfusion

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

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

Conditions
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Myocardial Reperfusion, Myocardial Infarction

Intervention / Treatment
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* Procedure: Post-conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-conditioning<br> | Procedure: Post-conditioning<br>* 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.<br>|
| No Intervention: Conventional primary PCI<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dichotomous rate of complete ST-segment resolution (STR) |  | at 30 minutes after final contrast injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial blush grade |  | within 10 minutes after PCI | 
| Thrombolysis in Myocardial Infarction (TIMI) flow grade |  | within 10 minutes after PCI | 
| Angiographic no-reflow |  | during PCI | 
| All death |  | at 30 days and 1 year | 
| Stent thrombosis |  | at 30 days and 1 year | 
| Cardiac death |  | at 30 days and 1 year | 
| Myocardial infarction |  | at 30 days and 1 year | 
| Severe heart failure | 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. | at 30 days and 1 year | 
| Target vessel revascularization (TVR) |  | at 30 days and 1 year | 
| Composite of death, MI, severe heart failure, or stent thrombosis |  | at 30 days and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary