Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression

NCT05436977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-20

No results posted yet for this study

Summary

Data from human autopsy studies have showed that thrombosis of a ruptured plaque with a large necrotic core, inflammatory cells and a thin fibrous cap, the so-called thin cap fibroatheroma (TCFA), represents the main mechanism for acute coronary syndrome (ACS). Optical coherence tomography (OCT) is an imaging technique that provides high-resolution, cross-sectional images of tissue in situ. The resolution of OCT (10 um) is appropriate for measuring a cap thickness less than65 μm, and even the plaque macrophage density. 68Ga-DOTA-(Tyr3)-octreotate/NaI3-octreotide(68Ga-DOTA-TATE/NOC) Positron Emission Tomography (PET)/Computed Tomography coronary angiography (CTCA), targeting the somatostatin receptor subtype-2 selectively expressed by M1 macrophages may show coronary inflammation. The SHORE protocol aims at evaluating the synergy between OCT and 68Ga-DOTA-TATE/NOC in predicting coronary plaque progression as assessed by CTCA

Conditions

Interventions

DIAGNOSTIC_TEST

coronary OCT

Intermediate coronary lesions will be evaluated by OCT

DIAGNOSTIC_TEST

68GaDOTATATE PET/CTCA

Intermediate coronary lesions will be evaluated by68GaDOTATATE PET/CTCA

Sponsors & Collaborators

  • University of Cambridge

    collaborator OTHER
  • Centro per la Lotta Contro l'Infarto - Fondazione Onlus

    collaborator OTHER
  • University of Bologna

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2024-06-21
Completion
2024-06-21

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436977 on ClinicalTrials.gov