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

NCT05436977 | Completed

• 1 other identifier: SHORE_Bo_2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndrome; Atherosclerosis; Inflammation; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Coronary Plaque Progression

  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

  2 years

Secondary Outcomes (1)

• Coronary Plaque Progression

  2 years

Other Outcomes (1)

• Relationship between OCT and PET findings

  baseline

Interventions

coronary OCT DIAGNOSTIC_TEST

Intermediate coronary lesions will be evaluated by OCT

68GaDOTATATE PET/CTCA DIAGNOSTIC_TEST

Intermediate coronary lesions will be evaluated by68GaDOTATATE PET/CTCA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead
• University of Cambridge: collaborator
• Centro per la Lotta Contro l'Infarto - Fondazione Onlus: collaborator

Study Sites (1)

University of Bologna IRCCS Policlinico di St. Orsola

Bologna, Italy

Location

Related Publications (2)

• Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.

  PMID: 31504405 RESULT

• Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.

  PMID: 28385306 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Atherosclerosis; Inflammation; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 29, 2022
• Study Start: June 21, 2021
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: May 20, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

IT (1)