Myocardial InfarctionIDEA-CVRNCT07252830
Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm. (IDEA-CVR)
An observational study of Myocardial Infarction and Atheroma, run by Elsan at 1 site in France.
Trial summary
To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Myocardial Infarction, Atheroma, Cholesterol
- What is being tested?
- SCORE2
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2021to 20 Jan 2026
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology team of the Poitiers polyclinic (France)
Who may be able to join
- Age > 40 years and < 80 years referred to general cardiology consultation
- LDL-C level > 1.6 g/L, or LDL-C level > 1.3 g/L with at least one associated major cardiovascular (CV) risk factor (RCF) (smoking, hypertension, diabetes).
- Coronary artery reserve assessment and EDTSA performed in a day hospital
Who cannot join
- Known or suspected carotid atherosclerotic disease
- Significant ischemic heart disease known or suspected at the time of the initial consultation
- Protected adult patient (patient under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision)
- Opposition expressed by the patient to the use of their health data.
- Patient may have limited understanding of the information sheet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurelia Cassany, Dr contact
France1 site, 1 recruiting
- Recruiting
Polyclinqiue de Poitiers
Poitiers, 86000
Barnabas Gellen, Dr, +33 5 49 61 71 99
About this study
Official title: Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm.
To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their progression constitute the most promising primary prevention strategy. In younger subjects, the main modifiable pro-atheromatous factors are smoking and an excessively high LDL-C level, partly genetically predetermined, but also favored by a diet too rich in saturated fats and a lack of physical activity. In the French national MI registry, the average age of patients is 62 years (Arch Cardiovasc Dis 2021 Oct;114(10):647-655). Half of MIs therefore occur at working age due to rupture of atheromatous plaques, which had developed during the months/years preceding the acute event.
According to the latest recommendations of the European Society of Cardiology (ESC) on CV prevention published in August 2021, the visualization of coronary or carotid atheromatous plaques justifies considering the patient as having atherosclerotic cardiovascular disease (ASCVD), and automatically places them in the "very high CV risk" category, with an LDL-cholesterol target of <0.55 g/L. However, these recommendations do not clearly define the criteria justifying the use of imaging in asymptomatic patients.
Read more
In current practice, CV risk stratification for asymptomatic patients with no prior CV disease is currently based on risk calculation using the European "SCORE 2" algorithm, available online. It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years.
The main objective of this study is to describe patients reclassified as "very high CV risk" following the detection of atheroma plaques formed in relation to their risk level estimated by SCORE2.
Read the detailed description
It is a national, single-center, retrospective and prospective study on the collection of routine care data.
- Conditions
- Myocardial Infarction, Atheroma, Cholesterol, Cardiovascular (CV) Risk
- Being tested
- SCORE2
- Medical subject headings
- Myocardial Infarction, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCORE2Other
the European algorithm "SCORE 2", available online (figure 1). It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients, in screening / primary prevention | Not described Receives: Other: SCORE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very high risk cardiovascular (yes/no)
Patients reclassified as "very high CV risk" (Yes/No) compared to the risk level estimated by SCORE2.
SCORE2 is determined by an online calculator from the European Society of Cardiology (ESC).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start12 Sep 2021
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- Polyclinique Poitiers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252830
- Sponsor's protocol ID
- IDEA-CVR
- Acronym
- IDEA-CVR
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm.
- ClinicalTrials.gov ID
- NCT07252830
- Acronym / sponsor ID
- IDEA-CVR / IDEA-CVR
- Conditions
- Myocardial Infarction, Atheroma, Cholesterol, Cardiovascular (CV) Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- Polyclinique Poitiers
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their progression constitute the most promising primary prevention strategy. In younger subjects, the main modifiable pro-atheromatous factors are smoking and an excessively high LDL-C level, partly genetically predetermined, but also favored by a diet too rich in saturated fats and a lack of physical activity. In the French national MI registry, the average age of patients is 62 years (Arch Cardiovasc Dis 2021 Oct;114(10):647-655). Half of MIs therefore occur at working age due to rupture of atheromatous plaques, which had developed during the months/years preceding the acute event.
According to the latest recommendations of the European Society of Cardiology (ESC) on CV prevention published in August 2021, the visualization of coronary or carotid atheromatous plaques justifies considering the patient as having atherosclerotic cardiovascular disease (ASCVD), and automatically places them in the "very high CV risk" category, with an LDL-cholesterol target of <0.55 g/L. However, these recommendations do not clearly define the criteria justifying the use of imaging in asymptomatic patients.
In current practice, CV risk stratification for asymptomatic patients with no prior CV disease is currently based on risk calculation using the European "SCORE 2" algorithm, available online. It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years.
The main objective of this study is to describe patients reclassified as "very high CV risk" following the detection of atheroma plaques formed in relation to their risk level estimated by SCORE2.
Detailed description
It is a national, single-center, retrospective and prospective study on the collection of routine care data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients, in screening / primary prevention | – | Other: SCORE2 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology team of the Poitiers polyclinic (France)
Key inclusion criteria (3 listed)
- Age > 40 years and < 80 years referred to general cardiology consultation
- LDL-C level > 1.6 g/L, or LDL-C level > 1.3 g/L with at least one associated major cardiovascular (CV) risk factor (RCF) (smoking, hypertension, diabetes).
- Coronary artery reserve assessment and EDTSA performed in a day hospital
Key exclusion criteria (5 listed)
- Known or suspected carotid atherosclerotic disease
- Significant ischemic heart disease known or suspected at the time of the initial consultation
- Protected adult patient (patient under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision)
- Opposition expressed by the patient to the use of their health data.
- Patient may have limited understanding of the information sheet
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 |
|---|---|---|
| SCORE2the European algorithm "SCORE 2", available online (figure 1). It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years. | Other | Asymptomatic patients, in screening / primary prevention |
Primary outcome
Very high risk cardiovascular (yes/no)
Time frame: 12 months
Patients reclassified as "very high CV risk" (Yes/No) compared to the risk level estimated by SCORE2. SCORE2 is determined by an online calculator from the European Society of Cardiology (ESC).
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 28 Nov 2025.
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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.
Aurelia Cassany, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Atheroma, run by Elsan at 1 site in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Nov 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 France. 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?
Contact Aurelia Cassany, Dr (cassany@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Very high risk cardiovascular (yes/no) (time frame: 12 months). 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 28 Nov 2025.