NCT05436977Completed
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
Source: ClinicalTrials.gov · Last updated 20 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 1 Jun 2022
- Start date
- 21 Jun 2021
- Primary completion date
- 21 Jun 2024
- Lead sponsor
- University of Bologna
- Diseases
- Coronary artery disease
- NCT number
- NCT05436977
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 21 Jun 2021 to the primary completion date, 21 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of systemic corticosteroids
- Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
Other illness
- Contrast allergy or contrast-nephropathy
- Uncontrolled chronic inflammatory disorder
- History of recent malignancy deemed relevant to the study by the investigator
- Severe valvular heart disease
- Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study.
Lab values
- Chronic kidney disease (eGFR \<30 l/min/1.73m2)
Other
- Women of child bearing potential not using adequate contraception
- Uncontrolled atrial fibrillation
- Contraindication to coronary angiography
- Requires CABG or staged non-culprit artery PCI
- Coronary vessels that could not be adequately imaged
Who the study is looking for
- Male or female participants \> 50 years old
- Able to give written, informed consent and to lie flat
- Presentation of ACS within \~2 weeks
- At least 1 intermediate (30-80% diameter stenosis) non-culprit coronary artery lesion on angiography, managed medically as clinically indicated (i.e.: negative FFR/iFR)
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bologna IRCCS Policlinico di St. Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.