Iwate Medical University Hospital
Morioka, 020-8505, Japan
NCT Number: NCT02014753
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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Notify Me20 year and older
All sexes
Observational
Morioka, 020-8505, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Other names: XIENCE PRIME, XIENCE Xpedition
Time frame: 2 weeks
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.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke
Time frame: 2 weeks and 3 months
Time frame: 12 month
Time frame: 12 month
Time frame: At the time of OCT follow-up (2 weeks or 3 months) and 12 month s
(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.
Iwate Medical University
Other
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial Infarction: MECHANISM-AMI
Acronym: MECHANISM-AMI
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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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