Coronary Artery Disease Clinical Trial
Official title:
Evaluation of Delayed Plaque Morphology by Optical Coherence Tomography (OCT) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI) After Thrombus Aspiration During Primary Percutaneous Intervention (PCI)
The purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy.
Current guideline for treating acute STEMI is primarily PCI and stent placement in the
infarct-related coronary artery. But, the underlying plaque morphology is not routinely
identified due to the limited resolution of conventional imagine modalities. However,
autopsy studies have shown that there are different atherosclerotic plaque morphologies
involving in acute thrombotic occlusion of coronary arteries other than atherosclerotic
plaque rupture, such as plaque erosion, calcified nodule, etc. Some studies have suggested
that PCI and stenting might not always be necessary in about 30 - 40% of ACS patients, and
an alternative treatment strategy is needed for these patients based on the characteristics
of plaque morphology.
100 subjects who meet the inclusion/exclusion criteria will undergo emergent angiography and
followings: If no thrombus was observed, OCT examination will be performed in the target
vessel;
If thrombosis was confirmed, the subject will undergo manual aspiration thrombectomy and
antiplatelet therapy, and TIMI flow will be assessed:
If TIMI flow grade < 3, the subject will receive stent implantation as the standard of care
followed by OCT examination; If TIMI flow grade of 3, the subject will not receive stent
implantation but will be sent to CCU for monitoring and antiplatelet treatment, and have a
repeat angiography and OCT examination at Day 7; within the 7days post STEMI,
ischemia-driven angiography and/or PCI are allowed, and an OCT examination will be performed
in these subject before PCI.
Patients without undergoing initial stent implantation will have scheduled 30-day and
12-month follow-ups for clinical outcomes.
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Observational Model: Cohort, Time Perspective: Prospective
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