Acute Coronary SyndromeSHORENCT05436977
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
A study testing coronary OCT and 68GaDOTATATE PET/CTCA in people with Acute Coronary Syndrome and Atherosclerosis, run by University of Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Atherosclerosis, Inflammation
- What is being tested?
- coronary OCT and 68GaDOTATATE PET/CTCA
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2021to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- coronary OCT, 68GaDOTATATE PET/CTCA
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis, Inflammation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary OCTDiagnostic test
Intermediate coronary lesions will be evaluated by OCT
68GaDOTATATE PET/CTCADiagnostic test
Intermediate coronary lesions will be evaluated by68GaDOTATATE PET/CTCA
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Coronary Plaque Progression
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start21 Jun 2021
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Centro per la Lotta Contro l'Infarto - Fondazione Onlus
- Responsible party
- Principal investigator, Nevio Taglieri, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436977
- Sponsor's protocol ID
- SHORE_Bo_2020
- Acronym
- SHORE
- Status last verified
- May 2024
- First submitted
- 1 Jun 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31504405Tarkin 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.
PubMed 28385306
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
- ClinicalTrials.gov ID
- NCT05436977
- Acronym / sponsor ID
- SHORE / SHORE_Bo_2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- University of Cambridge, Centro per la Lotta Contro l'Infarto - Fondazione Onlus
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary OCTIntermediate coronary lesions will be evaluated by OCT | Diagnostic test | – |
| 68GaDOTATATE PET/CTCAIntermediate coronary lesions will be evaluated by68GaDOTATATE PET/CTCA | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Coronary Plaque Progression
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Results publication: PubMed 31504405Prati 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.
- Results publication: PubMed 28385306Tarkin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary OCT and 68GaDOTATATE PET/CTCA in people with Acute Coronary Syndrome and Atherosclerosis, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Plaque Progression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.