Thrombus Aspiration and Pathology and OCT Study

NCT07151976 | Recruiting

• 1 other identifier: HM22-157
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Concordance between pathology based and optical coherence tomography (OCT) verified diagnosis of plaque rupture

  TAPOS is an observational prospective study that aims to investigate the concordance between pathology versus OCT-verified features of plaque rupture in patients with STEMI and NSTEMI undergoing PCI and athero-thombus aspiration from the culprit coronary plaque. Pathology measured features are assessed in the aspirated material retrieved from the target coronary plaque and include the presence of foam or iron-loaded macrophages, cholesterol clefts, fragments of fibrous tissue, and calcifications assessed as single or combined features. OCT-based features of plaque include coronary thrombi, fibrous cap discontinuity or plaque ulceration (contraposed to non-ruptured, continuous fibrous cap with over-imposed thrombus).

  From 2016 to 2027

Secondary Outcomes (5)

• Concordance between pathology-based and optical coherence tomography (OCT) verified detection of macrophages

  From 2016 to 2027

• The incidence rate of major adverse cardiac events (MACE)

  From 2016 to 2027

• The incidence rate of major adverse cardiac and cerebrovascular events (MACCE)

  From 2016 to 2027

• The incidence rate of major adverse cardiac and fatal events

  From 2016 to 2027

• The incidence rate of major cardiac, cerebrovascular, and fatal events

  From 2016 to 2027

Interventions

PCI DEVICE

PCI with athero-thrombotic aspiration and subsequent pathological analysis: Pathologic Characteristics of Athero-Thrombotic AsPirated Material of OCT-Verified Culprit Lesion in Acute Coronary Syndrome

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Between July 2016 and December 2024, 200 consecutive patients with ACS having large angiographic thrombus burden who assumed to have a merit of thrombotic aspiration and who consented to OCT guided PCI procedures with athero-thrombotic aspiration were enrolled in the study.

You may qualify if:

• Patients with ACS showing ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) are studied.
• Only native coronary artery lesions are included in the study.
• 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.
• All patients provided written informed consent for the index procedure, follow-up, and anonymous data management.

You may not qualify if:

• Patients are excluded from the study when they had cardiogenic shock and contraindications to anticoagulation and anti-platelet therapy.
• 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.

Sponsors & Collaborators

• Fujita Health University: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human atherosclerotic material

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• YUKIO OZAKI, MD, PhD

  Fujita Health University, Aichi, Japan

  PRINCIPAL INVESTIGATOR

• Eloisa Arbustini, MD

  IRCCS Foundation Policlinico San Matteo, Pavia, Italy

  STUDY CHAIR

Central Study Contacts

Yukio Ozaki, MD, PhD

CONTACT

+1 9492996512; ozakiyuk@fujita-hu.ac.jp

Reina Ozaki, MD

CONTACT

+1 9492996512; yukio.ozaki7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: September 3, 2025
• Study Start: July 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

JP (1)