Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression (SHORE)
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|ClinicalTrials.gov Identifier: NCT05436977|
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Atherosclerosis Inflammation Coronary Artery Disease||Diagnostic Test: coronary OCT Diagnostic Test: 68GaDOTATATE PET/CTCA||Not Applicable|
ACS are the leading cause of mortality and morbidity in the western world. Despite recommended therapies, after experiencing an ACS episode patients still have an increased cardiovascular risk during follow up. In the CLIMA study OCT criteria of plaque vulnerability at non-culprit sites such as minimum luminal area <3.5mm2, fibrous cap thickness <75 µm, lipid arc extension >180° and macrophage infiltration was associated with an increased risk of cardiac death and myocardial infarction (HR 7.54, 95%CI 3.1-18.6).
Of the 36 OCT defined vulnerable plaques only 7 were associated with events showing a very low positive predictive value (19%). Yet, among the 577 plaques with macrophages accumulation only the 5.2% was associated with the endpoint. The lack of reliable information on plaque inflammation could represent the miss point to better link high risk plaques to plaque progression and/or rupture. Recent studies showed that inflammation in coronary plaques may be measured by means 68Ga-DOTATATE/PET targeting the somatostatin receptor subtype-2 selectively expressed by M1 macrophages.
Thus the investigators aim to evaluate the in vivo natural history of coronary plaques characterized from both the morphological (OCT) and inflammatory (68Ga-DOTATATE PET/CTCA) point of view in patients with ACS and at least 1 intermediated coronary lesion as assessed by FFR/iFR
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
The coronary OCT images acquired will be analyzed off-line by an independent imaging core laboratory (Euroimage Research, Rome, Italy), using validated review stations. OCT-defined plaque classification was performed according to an international consensus statement and validated criteria.
PET-CT and CT coronary angiography images will be analyzed off-line in an experienced imaging laboratory by our collaborators at the University of Cambridge.
|Official Title:||Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||June 21, 2024|
|Estimated Study Completion Date :||June 21, 2024|
- 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
- Coronary Plaque Progression [ Time Frame: 2 years ]Comparison of baseline non culprit OCT imaging and baseline 68Ga-DOTANOC tissue-to-blood ratio in patients with significant plaque progression measured by CTCA (defined by changes in low attenuation plaque volume and total atheroma volume), versus those without
- Coronary Plaque Progression [ Time Frame: 2 years ]Comparison of baseline non culprit OCT imaging and 12 weeks 68Ga-DOTANOC tissue-to-blood ratio in patients with significant plaque progression measured at 2 years follow up by CTCA (defined by change in low attenuation plaque volume and total atheroma volume), versus those without
- Relationship between OCT and PET findings [ Time Frame: baseline ]Comparison of 68Ga-DOTANOC imaging to OCT assessed plaque morphology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436977
|Contact: Nevio Taglieri, MDemail@example.com|
|University of Bologna IRCCS Policlinico di St. Orsola||Recruiting|
|Contact: Nevio Taglieri, MD|
|Principal Investigator: Nevio Taglieri, MD|