Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05436977
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2022-06-01
Brief Title:
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHORE
Brief 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-octreotateNaI3-octreotide68Ga-DOTA-TATENOC Positron Emission Tomography PETComputed 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-TATENOC in predicting coronary plaque progression as assessed by CTCA
Detailed Description:
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 35mm2 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 754 95CI 31-186
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 52 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 andor rupture Recent studies showed that inflammation in coronary plaques may be measured by means 68Ga-DOTATATEPET 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 PETCTCA point of view in patients with ACS and at least 1 intermediated coronary lesion as assessed by FFRiFR
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 52 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 andor rupture Recent studies showed that inflammation in coronary plaques may be measured by means 68Ga-DOTATATEPET 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 PETCTCA point of view in patients with ACS and at least 1 intermediated coronary lesion as assessed by FFRiFR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None