Myocardial Infarction, Myocardial Reperfusion
Conditions
Keywords
Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary
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.
Interventions
PROCEDUREPost-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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dichotomous rate of complete ST-segment resolution (STR) | at 30 minutes after final contrast injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Myocardial blush grade | within 10 minutes after PCI | — |
| Myocardial infarction | at 30 days and 1 year | — |
| Severe heart failure | 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. |
| 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 | — |
| Cardiac death | at 30 days and 1 year | — |
Countries
South Korea
Outcome results
None listed