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To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoCr-EES, 2-week OCT follow-up | Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI. |
| |
| CoCr-EES, 3-month OCT follow-up | Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cobalt-chromium everolimus-eluting stent (CoCr-EES) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of stent strut coverage by OCT | To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-months arm will also be evaluated in a complementary manner, separately from the 2-weeks arm. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding | 1 year | |
| Any Target Lesion Revascularization (TLR) | 1 year | |
| Clinically-driven TLR |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Aggregation Test | (1) at the time of PCI, (2) at the time of OCT at 2 weeks or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event. | At the time of OCT follow-up (2 weeks or 3 months) and 12 month s |
Inclusion Criteria:
- AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundlebranch block (LBBB).
Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Identification of an intracoronary thrombus by angiography or autopsy Of the AMI patients who met the above definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new ST elevation at the J point in at least 2 contiguous leads of equal or greater than2 mm (0.2 mV) in men equal or greater than1.5 mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
Exclusion Criteria:
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primary care clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iwate Medical University Hospital | Morioka | 020-8505 | Japan |
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| 1 year |
| Any Target Vessel Revascularization (TVR) | 1 year |
| Coronary-artery bypass surgery (CABG) | 1 year |
| Any revascularization | 1 year |
| Angiographic binary restenosis | 1 year |
| Patient-oriented composite | Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke | 1 year |
| OCT Endpoint |
| 2 weeks and 3 months |
| Angiographic Quantitative analysis |
| 12 month |
| Angiographic Qualitative analysis |
| 12 month |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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