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NCT04701385: PEPSii
Plaque Erosion Prospective Study ii
trial testing Optical Coherence Tomography (OCT) in Atheroma; Myocardial in 33 participants. Completed in 31 January 2023.
31 January 2022
Quick facts
| Lead sponsor | Norfolk and Norwich University Hospitals NHS Foundation Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 33 |
| Start date | 15 October 2020 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 January 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Optical Coherence Tomography (OCT)
Conditions studied
- Atheroma; Myocardial — all drugs for Atheroma; Myocardial →
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):
-
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:
- PubMed search for NCT04701385
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Norfolk and Norwich University Hospitals NHS Foundation Trust trials
Trials by the same sponsor.
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- NCT06856122 — Pharmacogenomics to Improve Supportive Care Symptoms. · enrolling by invitation
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04701385 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Norfolk and Norwich University Hospitals NHS Foundation Trust
- Last refreshed: 18 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04701385.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing