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NCT04701385: PEPSii

Plaque Erosion Prospective Study ii

Completed Last updated 18 December 2023
What this trial tests

trial testing Optical Coherence Tomography (OCT) in Atheroma; Myocardial in 33 participants. Completed in 31 January 2023.

Timeline
15 October 2020
Primary endpoint
31 January 2022
31 January 2023

Quick facts

Lead sponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date15 October 2020
Primary completion31 January 2022
Estimated completion31 January 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Who can join

Adults 18 to 75, any sex, with Atheroma; Myocardial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Plaque erosion is associated with myocardial infarction (MI) in about 30% of cases and may require a different management approach to plaque rupture. The investigators hypothesise that plaque erosion leads to higher levels of apoptotic circulating endothelial cells (CECs) compared to plaque rupture. Aims: To compare associations between plaque erosion and plaque rupture with numbers and types of apoptotic CECs in patients with non-ST elevation MI (NSTEMI) and stable coronary artery disease controls (CAD). Additional aims are to explore signals of cellular stress (mitochondrial dsDNA), sub-populations of activated neutrophils, circulating endothelial progenitor cells and erosion-specific plasma biomarkers. Methods: Prospective observational study of 80 patients with NSTEMI and 40 patients with stable CAD. Plaque erosion or rupture will be identified by intracoronary Optical Coherence Tomography (OCT). CECs and neutrophils will be quantified and characterised using flow cytometry looking at markers of cell death and neutrophil activation. Plasma will be analysed by proteomic methods (Olink) and for mitochondrial dsDNA. Potential importance of findings: This study will provide evidence for the hypothesised mechanism of plaque erosion and clarify if biomarker analysis in NSTEMI patients provides a basis for non-invasive diagnosis of plaque erosion versus rupture.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Precision Medicine in Acute Coronary Syndromes.
    Caffè A, Animati FM, Iannaccone G, Rinaldi R, et al · · 2024 · cited 3× · PMID 39124834 · DOI 10.3390/jcm13154569

Verify or expand the search:

Other trials of Optical Coherence Tomography (OCT)

Trials testing the same drug.

Other Norfolk and Norwich University Hospitals NHS Foundation Trust trials

Trials by the same sponsor.

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Data sources for this page

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