NCT07151976 Thrombus Aspiration and Pathology and OCT Study
| NCT ID | NCT07151976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujita Health University |
| Condition | Acute Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2016-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2016-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Most acute coronary syndromes (ACS) are caused by plaque complications triggering thrombotic events in the culprit plaques. Plaque complications include plaque rupture (Ruptured Fibrous Cap-RFC) with exposure of highly thrombogenic substrate to the flow and plaque erosion (Intact Fibrous Cap-IFC) a condition characterized by endothelial/intimal damage occurring over non-ruptured plaques. Far less commonly (\<5%), calcified nodules (CN) may trigger acute coronary thrombosis. Plaque rupture accounts for 75% of fatal AMI in autopsy series, while erosion is found in about 25% of cases. These proportions have been supported by in vivo invasive studies (OCT) and OCT-pathology correlation studies. However, it remains unclear whether OCT findings consistently align with in vivo pathology-based evidence of RFC in ACS. Guidelines addressing treatments of ACS unanimously indicate percutaneous coronary intervention (PCI) to restore the coronary flow. Pre-PCI thrombus aspiration is not currently indicated by most guidelines, with the exception of cases with very high thrombus burden. The samples retrieved from thrombus aspiration can be suitable for pathology investigation and aim to evaluate the presence of plaque components in the context of the thrombotic material, a finding that demonstrates plaque rupture as the substrate for the acute coronary event. These studies are uniquely qualified to provide information on the correct OCT-based interpretation of plaque complications in ACS and require OCT imaging quality suitable to classify RFC, IFC, and CN. Therefore, a prospective OCT-pathology study was designed using the pre-PCI aspirated material from patients with high thrombus burden, to explore the contribution of pathology study in OCT-based classification of plaque complications.
Eligibility Criteria
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.
Contact & Investigator
YUKIO OZAKI, MD, PhD
PRINCIPAL INVESTIGATOR
Fujita Health University, Aichi, Japan
Frequently Asked Questions
Who can join the NCT07151976 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07151976 currently recruiting?
Yes, NCT07151976 is actively recruiting participants. Contact the research team at ozakiyuk@fujita-hu.ac.jp for enrollment information.
Where is the NCT07151976 trial being conducted?
This trial is being conducted at Toyoake, Japan.
Who is sponsoring the NCT07151976 clinical trial?
NCT07151976 is sponsored by Fujita Health University. The principal investigator is YUKIO OZAKI, MD, PhD at Fujita Health University, Aichi, Japan. The trial plans to enroll 200 participants.