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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
Sponsor:
Collaborators:
University of Cambridge
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Information provided by (Responsible Party):
Nevio Taglieri, University of Bologna

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)-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

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

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 <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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Relationship between OCT and PET findings [ Time Frame: baseline ]
    Comparison of 68Ga-DOTANOC imaging to OCT assessed plaque morphology



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Women of child bearing potential not using adequate contraception
  • Contrast allergy or contrast-nephropathy
  • Uncontrolled atrial fibrillation
  • Chronic kidney disease (eGFR <30 l/min/1.73m2)
  • Uncontrolled chronic inflammatory disorder
  • History of recent malignancy deemed relevant to the study by the investigator
  • Current use of systemic corticosteroids
  • Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
  • Contraindication to coronary angiography
  • Requires CABG or staged non-culprit artery PCI
  • Coronary vessels that could not be adequately imaged
  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nevio Taglieri, MD +390512144475 nevio.taglieri@unibo.it

Locations
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Italy
University of Bologna IRCCS Policlinico di St. Orsola Recruiting
Bologna, Italy
Contact: Nevio Taglieri, MD         
Principal Investigator: Nevio Taglieri, MD         
Sponsors and Collaborators
University of Bologna
University of Cambridge
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Publications of Results:
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Responsible Party: Nevio Taglieri, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT05436977    
Other Study ID Numbers: SHORE_Bo_2020
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This protocol has been designed in collaboration with researchers in the United Kingdom, with the intention of combining data from the SHORE study with the Residual Inflammation and Plaque Progression Long-term Evaluation (RIPPLE; NCT04073810) study that is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Trust, UK.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available after the recruiting phase and till the end of the study
Access Criteria: Only investigators of the Ripple study will have access to the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Atherosclerosis
Inflammation
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases