AtherosclerosisSPECTRENCT06013722
Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease
A study testing 18F-Na PET Scan in people with Atherosclerosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
Trial summary
Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- 18F-Na PET Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMonaco
- Study dates
- 18 Mar 2024to 24 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with no coronary history presenting to the emergency room, to the assessment unit or having consulted in the cardiology department for suspicious chest pain that does not allow an acute coronary syndrome or angina to be excluded and:
- in whom the diagnosis of acute coronary syndrome has been ruled out on the basis of clinical, electrocardiographic, biological monitoring, or even by imaging (including coronary angiography), in accordance with recommendations and good practices
- in whom effort myocardial ischemia is rendered unlikely on the basis of a clinical and paraclinical evaluation (either ergometric or by functional imaging: scintigraphy, echography or stress MRI)
- wishing diagnostic care and primary prevention of coronary disease.
- Age above or equal to 18 and strictly below 80 years old
- Having given informed consent
Who cannot join
- Pregnant woman
- Patient with cognitive disorders
- Claustrophobic patient, or refusing radiological examinations
- Patient refusing cardiological follow-up and/or treatment of his risk factors or refusing to participate in the study
- Patient with contraindications or intolerances to HMG-CoA reductase inhibitors (statins) and/or Ezetimibe
- Patient with liver failure
Show all 16Show fewer
- Patient with myopathy or with a history of (rhabdo)myolysis
- Marked arrhythmia and in particular supraventricular or ventricular hyperexcitability, or chronic or paroxysmal atrial fibrillation not controlled by antiarrhythmic treatment
- Patients with a history of sternotomy or valve replacement or metallic intracardiac probes, generators of scanner artefacts
- Calcium score corresponding to the percentiles of groups I and II
- For patients in groups III and IV:
- renal insufficiency with glomerular filtration rate estimated by the MDRD and/or CKD-EPI formula less than or equal to 55 ml/min/1.73 m2,
- known intolerance to radiological contrast products, or in whom an injected CT scan has already been performed in the 6 months preceding inclusion
- Person participating in another biomedical research
- Person under judicial protection (guardianship, curatorship...)
- Person deprived of liberty by a judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategy for Unstable Coronary Plaque in Patients Presenting to the Emergency Department for Chest Pain Suspected of Coronary Artery Disease. A Trial in Primary Prevention and Cardiovascular Risks Evaluation
Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing plaque, asymptomatic before the event since without significant reduction in coronary flow, particularly during a stress test or during stress imaging.
Study purpose is to set up, in medical emergency department, check-up unit and cardiology department, a primary prevention strategy articulated around a routine examination: calcium scoring. The latter makes it possible to categorize patients according to their risk of generating atheromatous plaques and to classify them into several risk levels (groups) according to their score: low (<40th percentile), intermediate (between the 40th percentile and the 65th percentile: group III) or high risk (>65th percentile, group IV). 18F-Na PET scan can mark unstable coronary plaques. For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.
Read the detailed description
The purpose of this protocol is to determine the frequency and the mapping of unstable coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well as their evolution under treatment.
Aside from traditional risk factors collection and related biological assessments, risk establishment is based on calcium score, a simple non-injected and very little irradiating scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity, therefore makes it possible to assign a percentile within the distribution of all the patients and to classify patients in:
- Group I: "absence of atheromatous plaques": Score 0
- Group II: patients generating few plaques (low risk): calcium score above zero and classifying the patient below the 40th percentile of a similar population;
- Group III: patients generating moderate plaques (intermediate risk) with a calcium score classifying the patient equal or above the 40th percentile and less than the 65th percentile;
- Group IV: patients generating a lot of plaques (high risk): calcium score classifying the patient equal or above the 65th percentile. These are more likely to be patients who will come from the cardiology / check-up sector because of a higher probability of symptoms or of already being treated for primary prevention.
Study assumptions are:
- apart from any hemodynamically significant coronary stenosis, the instability of a plaque can lead to symptomatic but transient micro-thrombotic phenomena which are spontaneously (or under the effect of an anti-aggregation/anticoagulation) resorbable. Regardless of this plaque fate (most frequently scarring, with calcifications, or much more rarely inaugural acute coronary syndrome and therefore infarction), it is a major coronary event which must switch the patient from primary prevention to secondary prevention;
- on painful thoracic syndromes that are sufficiently suggestive to require immediately to rule out an acute coronary syndrome or secondarily myocardial ischemia (angina), identifying a rapid progression of the coronary involvement (on the basis of calcium score) or the direct demonstration of plaque instability (by 18F-Na coupled with a CT scan) is a major cardiovascular prevention endpoint;
- in patients consulting for this clinical presentation, determining the frequency of those with rapid coronary evolution and/or instability of coronary plaque(s) represents a fundamental preliminary epidemiological study to modify prevention approach of primary coronary artery disease;
- the evaluation by non-invasive coronary imaging of secondary prevention treatment impact on these same patients initially diagnosed as "rapidly progressive" and/or unstable would make it possible to consolidate this strategy if it proves to be effective on the basis of plaque images and clinical follow-up (in terms of events).
- Conditions
- Atherosclerosis
- Being tested
- 18F-Na PET Scan
- Keywords
- Atherosclerotic plaques, Acute coronary syndrome, 18F-Na PET, Coronary Artery Calcification Score
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Na PET ScanDiagnostic test
For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.
| Study group | Role | What they receive |
|---|---|---|
| Patients of groups III and IV | Experimental | Patients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: >65th percentile). Receives: Diagnostic Test: 18F-Na PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstable coronary plaque evolution description through calcium score variation
Unstable coronary plaque evolution will be described through calcium score variation calculation.
Measured: 8 months
Unstable coronary plaque evolution description through coro-scanner plaque size variations
Unstable coronary plaque evolution will be described through coro-scanner plaque size variations measurement
Measured: 8 months
Unstable coronary plaque evolution description through coro-scanner plaque density variations
Unstable coronary plaque evolution will be described through coro-scanner plaque density variations measurement
Measured: 8 months
Unstable coronary plaque evolution description through coro-scanner morphological aspect variations
Unstable coronary plaque evolution will be described through coro-scanner morphological aspect variations
Measured: 8 months
Unstable coronary plaque evolution description through coro-scanner variations in terms of stenosis diameter
Unstable coronary plaque evolution will be described through coro-scanner variations in terms of stenosis diameter
Measured: 8 months
Unstable coronary plaque evolution description through 18F-Na PET scan target binding variations
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (number of targets).
Measured: 8 months
Unstable coronary plaque evolution description through 18F-Na PET scan binding intensity variations
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (SUVmax for each target).
Measured: 8 months
Secondary outcomes (3)
Effectiveness of primary cardiovascular prevention strategy initiation by the care team
Evaluation at study end of the number of patients having entered the monitoring system, the number of patients with signs of coronary involvement and percentage of patients with coronary progression criteria.
Measured: 24 months
Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a "secondary prevention type" treatment
The number of persistent symptoms increasing and leading to the prescription of new tests (based on clinical management and good practices) and the number of symptoms having completely disappeared will be compared between the study cohort and the local historical one.
Measured: 24 months
Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest
Number of following cardiovascular events will be presented:
- angina proved by biology, ECG and functional and/or anatomical imaging,
- coronary revascularization in the territory of the unstable plaque if it is individualized or any revascularization (angioplasty or bypass),
- myocardial infarction,
- occurrence of a ventricular arrhythmia,
- cardiovascular death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start18 Mar 2024
- Primary completion24 Jul 2025
- Study completion24 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Monaco Scientific center
- Responsible party
- Sponsor
- Investigators
- Yann-Erick CLAESSENS, MD-PhD, Study director, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013722
- Sponsor's protocol ID
- 2023-CHITS-007
- Acronym
- SPECTRE
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Unstable Coronary Plaque in Patients Presenting to the Emergency Department for Chest Pain Suspected of Coronary Artery Disease. A Trial in Primary Prevention and Cardiovascular Risks Evaluation
- ClinicalTrials.gov ID
- NCT06013722
- Acronym / sponsor ID
- SPECTRE / 2023-CHITS-007
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerotic plaques, Acute coronary syndrome, 18F-Na PET, Coronary Artery Calcification Score
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Monaco Scientific center
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 28 Aug 2023 (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.
Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing plaque, asymptomatic before the event since without significant reduction in coronary flow, particularly during a stress test or during stress imaging.
Study purpose is to set up, in medical emergency department, check-up unit and cardiology department, a primary prevention strategy articulated around a routine examination: calcium scoring. The latter makes it possible to categorize patients according to their risk of generating atheromatous plaques and to classify them into several risk levels (groups) according to their score: low (<40th percentile), intermediate (between the 40th percentile and the 65th percentile: group III) or high risk (>65th percentile, group IV). 18F-Na PET scan can mark unstable coronary plaques. For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.
Detailed description
The purpose of this protocol is to determine the frequency and the mapping of unstable coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well as their evolution under treatment.
Aside from traditional risk factors collection and related biological assessments, risk establishment is based on calcium score, a simple non-injected and very little irradiating scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity, therefore makes it possible to assign a percentile within the distribution of all the patients and to classify patients in:
- Group I: "absence of atheromatous plaques": Score 0
- Group II: patients generating few plaques (low risk): calcium score above zero and classifying the patient below the 40th percentile of a similar population;
- Group III: patients generating moderate plaques (intermediate risk) with a calcium score classifying the patient equal or above the 40th percentile and less than the 65th percentile;
- Group IV: patients generating a lot of plaques (high risk): calcium score classifying the patient equal or above the 65th percentile. These are more likely to be patients who will come from the cardiology / check-up sector because of a higher probability of symptoms or of already being treated for primary prevention.
Study assumptions are:
- apart from any hemodynamically significant coronary stenosis, the instability of a plaque can lead to symptomatic but transient micro-thrombotic phenomena which are spontaneously (or under the effect of an anti-aggregation/anticoagulation) resorbable. Regardless of this plaque fate (most frequently scarring, with calcifications, or much more rarely inaugural acute coronary syndrome and therefore infarction), it is a major coronary event which must switch the patient from primary prevention to secondary prevention;
- on painful thoracic syndromes that are sufficiently suggestive to require immediately to rule out an acute coronary syndrome or secondarily myocardial ischemia (angina), identifying a rapid progression of the coronary involvement (on the basis of calcium score) or the direct demonstration of plaque instability (by 18F-Na coupled with a CT scan) is a major cardiovascular prevention endpoint;
- in patients consulting for this clinical presentation, determining the frequency of those with rapid coronary evolution and/or instability of coronary plaque(s) represents a fundamental preliminary epidemiological study to modify prevention approach of primary coronary artery disease;
- the evaluation by non-invasive coronary imaging of secondary prevention treatment impact on these same patients initially diagnosed as "rapidly progressive" and/or unstable would make it possible to consolidate this strategy if it proves to be effective on the basis of plaque images and clinical follow-up (in terms of events).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of groups III and IV | Experimental | Diagnostic Test: 18F-Na PET ScanPatients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: >65th percentile). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with no coronary history presenting to the emergency room, to the assessment unit or having consulted in the cardiology department for suspicious chest pain that does not allow an acute coronary syndrome or angina to be excluded and:
- Age above or equal to 18 and strictly below 80 years old
- Having given informed consent
Key exclusion criteria (16 listed)
- Pregnant woman
- Patient with cognitive disorders
- Claustrophobic patient, or refusing radiological examinations
- Patient refusing cardiological follow-up and/or treatment of his risk factors or refusing to participate in the study
- Patient with contraindications or intolerances to HMG-CoA reductase inhibitors (statins) and/or Ezetimibe
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 |
|---|---|---|
| 18F-Na PET ScanFor the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination. | Diagnostic test | Patients of groups III and IV |
Primary outcome
Unstable coronary plaque evolution description through calcium score variation
Time frame: 8 months
Unstable coronary plaque evolution will be described through calcium score variation calculation.
Unstable coronary plaque evolution description through coro-scanner plaque size variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner plaque size variations measurement
Unstable coronary plaque evolution description through coro-scanner plaque density variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner plaque density variations measurement
Unstable coronary plaque evolution description through coro-scanner morphological aspect variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner morphological aspect variations
Unstable coronary plaque evolution description through coro-scanner variations in terms of stenosis diameter
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner variations in terms of stenosis diameter
Unstable coronary plaque evolution description through 18F-Na PET scan target binding variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (number of targets).
Unstable coronary plaque evolution description through 18F-Na PET scan binding intensity variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (SUVmax for each target).
3 secondary outcomes
Effectiveness of primary cardiovascular prevention strategy initiation by the care team
Time frame: 24 months
Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a "secondary prevention type" treatment
Time frame: 24 months
Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Atherosclerosis
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Qatar Cardiometabolic Cohort
Cardiometabolic Diseases
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
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.
Yann-Erick CLAESSENS, MD-PhD study director
Centre Hospitalier Princesse Grace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Na PET Scan in people with Atherosclerosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. 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 Monaco. 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?
This study is still under way. Results are not available in the source record yet.
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?
Unstable coronary plaque evolution description through calcium score variation (time frame: 8 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.