Coronary Artery Disease, Myocardial Infarction
Conditions
Brief summary
The purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy.
Detailed description
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.
Interventions
angiography, manual aspiration thrombectomy and antiplatelet therapy
Sponsors
Study design
Eligibility
Inclusion criteria
1. Clinical inclusion criteria: * Age \> 18 years * Onset of STEMI \> 30 minutes, but \< 12 hours * ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG * Willing and able to provide informed consent 2. Angiographic inclusion criteria: * Having at least one infarct-related coronary artery, of which * The Culprit lesion is suitable for stenting; * The reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm; * The TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing * No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Exclusion criteria
1\. Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plaque morphology by OCT | at the 7th day post PCI/aspiration thrombectomy |
Secondary
| Measure | Time frame |
|---|---|
| Re-hospitalization due to cardiac symptoms | 30 days & 12 months |
| Myocardial infarction related to the target vessel | 30 days & 12 months |