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Delayed Plaque Morphology in Patients With STEMI After Thrombus Aspiration During Primary PCI

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02384824
Acronym
STEMI-OCT
Enrollment
100
Registered
2015-03-10
Start date
2015-04-30
Completion date
2017-10-31
Last updated
2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction

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

Jian'an Wang,MD,PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
plaque morphology by OCTat the 7th day post PCI/aspiration thrombectomy

Secondary

MeasureTime frame
Re-hospitalization due to cardiac symptoms30 days & 12 months
Myocardial infarction related to the target vessel30 days & 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026