Thrombus aspiration and OCT comparison in acute coronary syndromes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort compares the microscopic makeup of thrombus material aspirated during PCI with pre-PCI optical coherence tomography (OCT) images of the culprit plaque in patients presenting with STEMI or NSTEMI. Thrombus is collected during aspiration and processed for blinded pathology review, while OCT images are read independently to classify plaques as ruptured fibrous cap, intact fibrous cap (erosion), or calcified nodule. The primary aim is to determine whether aspirated material from OCT-defined ruptures contains plaque components (cholesterol clefts, foam cells, cap fragments, calcifications) while aspirates from erosions contain only thrombus. Secondary aims include characterizing M1/M2 macrophage presence in samples with plaque material and comparing short- and long-term clinical outcomes by imaging and pathology categories.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with ACS showing ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) are studied.
2. Only native coronary artery lesions are included in the study.
3. Optical coherence tomography (OCT) was performed prospectively to compare OCT culprit lesions characteristics with histological analysis of athero-thrombotic aspirated material of the culprit lesion. For this purpose, only lesions with both athero-thrombotic aspirated material and OCT observations are included in the study.
4. All patients provided written informed consent for the index procedure, follow-up, and anonymous data management.

Exclusion Criteria:

1. Patients are excluded from the study when they had cardiogenic shock and contraindications to anticoagulation and anti-platelet therapy.
2. Lesions located in tortuous vessels, in ostial segment and in the left main stem are excluded from the study due to the difficulty in performing high-quality intracoronary imaging.

Where it's running

• Fujita Health University
  Toyoake, Aichi-ken, Japan Recruiting

Study contacts

• Principal investigator: YUKIO OZAKI, MD, PhD — Fujita Health University, Aichi, Japan
• Study coordinator: Yukio Ozaki, MD, PhD
• Email: ozakiyuk@fujita-hu.ac.jp
• Phone: +1 9492996512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.