Diabetes MellitusTOSCANANCT05314140
Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study
An observational study of Diabetes Mellitus and Cardiovascular Diseases, run by French Cardiology Society at 9 sites in France.
Trial summary
There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Coronary artery calcium score evaluation
- How many people
- 0 participants
- Where
- 9 sitesFrance
- Study dates
- Jan 2025to 1 Jan 2028
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The centers participating in this study undertake to consecutively include all diabetic patients meeting the selection criteria and having a CT scan for evaluation of coronary artery calcium score. The indication for the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in accordance with the recommendations. This is a standard practice study. The patient will be informed of the possibility to participate to the study and his consent will be obtained by the cardiologist/diabetologist when it will be decided to perform a chest CT scan to estimate the coronary artery calcium score. All scanner prescriptions will be carried out according to clinical indications in standard practice.
Who may be able to join
- Coronary asymptomatic patient
- Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes for more than 10 years and aged 18 to 50 or - Patient with type 1 diabetes for more than 20 years and aged > 35
- Coronary artery calcium score evaluation planned
Who cannot join
- Patients who already have a clinical history of coronary disease
- Patients with other peripheral arterial disease
- Patients with clinical suspicion of coronary artery disease
- Patients with progressive cancer
- Patients with serious chronic conditions with an estimated life expectancy < 3 years.
- Pregnant, lactating, or pre-menopausal women without a recent negative pregnancy test available.
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- Patients under guardianship or curator or placed under justice safeguard
- Patients who do not benefit from the social security scheme, or any equivalent scheme
- Patients refusing or being linguistically or psychologically unable to sign the informed consent form
- Participation in another biomedical research protocol is permitted
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Bordeaux
Bordeaux, 33000
CHU de Limoges
Limoges, 87000
CHU de Nice
Nice, 06000
Hôpital Lariboisière, APHP
Paris, 75010
Hopital Saint Antoine
Paris, 75012
CHU de Poitiers
Poitiers, 86000
CHU de la Réunion
Saint-Denis, 97400
Centre de Cardiologie de Thionville
Thionville, 57100
CHU de Tours
Tours, 37000
About this study
There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.
Read the detailed description
The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients.
The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors.
The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk.
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Coronary artery calcium score evaluation
- Keywords
- Coronary artery calcium score, Heart failure risk factors, Prevention, Guidelines
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery calcium score evaluationDiagnostic test
The evaluation of the coronary artery calcium score will be performed with chest CT scan
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery calcium score evaluation | Patients with diabetes and having a CT scan for evaluation of their coronary artery calcium score will be consecutively include. The indication of the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in compliance with the recommendations Receives: Diagnostic Test: Coronary artery calcium score evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of diabetic patients with high coronary artery calcium score
Number of patient with diabetes having a coronary artery calcium score higher than 400
Measured: day 1
Secondary outcomes (3)
Proportion of patients having a coronary exploration
Number of patient with high coronary artery calcium (>400) score having a coronary exploration compared with patient with low coronary artery calcium score (<400)
Measured: 6 months
Proportion of patients having a myocardial revascularization
Number of patient with high coronary artery calcium score (>400) having a myocardial revascularization compared with patient with low coronary artery calcium score (<400)
Measured: 3 months
Description of adverse events regarding to the coronary artery calcium score
Calculation of number and type of cardiovascular adverse event within patient with high coronary artery calcium score (>400) or low coronary artery calcium score (<400)
Measured: 6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study startJan 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, CEBIMER
- Responsible party
- Sponsor
- Investigators
- Victor ABOYANS, MD, Principal investigator, University Hospital, LimogesTessa BERGOT, Study director, Société Française de la Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314140
- Sponsor's protocol ID
- 2021-01
- Acronym
- TOSCANA
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2022
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study
- ClinicalTrials.gov ID
- NCT05314140
- Acronym / sponsor ID
- TOSCANA / 2021-01
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Coronary artery calcium score, Heart failure risk factors, Prevention, Guidelines
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, CEBIMER
- Study start
- Jan 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Apr 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.
There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.
Detailed description
The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients.
The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors.
The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery calcium score evaluation | – | Diagnostic Test: Coronary artery calcium score evaluationPatients with diabetes and having a CT scan for evaluation of their coronary artery calcium score will be consecutively include. The indication of the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in compliance with the recommendations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The centers participating in this study undertake to consecutively include all diabetic patients meeting the selection criteria and having a CT scan for evaluation of coronary artery calcium score. The indication for the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in accordance with the recommendations. This is a standard practice study. The patient will be informed of the possibility to participate to the study and his consent will be obtained by the cardiologist/diabetologist when it will be decided to perform a chest CT scan to estimate the coronary artery calcium score. All scanner prescriptions will be carried out according to clinical indications in standard practice.
Key inclusion criteria (3 listed)
- Coronary asymptomatic patient
- Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes for more than 10 years and aged 18 to 50 or - Patient with type 1 diabetes for more than 20 years and aged > 35
- Coronary artery calcium score evaluation planned
Key exclusion criteria (10 listed)
- Patients who already have a clinical history of coronary disease
- Patients with other peripheral arterial disease
- Patients with clinical suspicion of coronary artery disease
- Patients with progressive cancer
- Patients with serious chronic conditions with an estimated life expectancy < 3 years.
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 artery calcium score evaluationThe evaluation of the coronary artery calcium score will be performed with chest CT scan | Diagnostic test | Coronary artery calcium score evaluation |
Primary outcome
Proportions of diabetic patients with high coronary artery calcium score
Time frame: day 1
Number of patient with diabetes having a coronary artery calcium score higher than 400
3 secondary outcomes
Proportion of patients having a coronary exploration
Time frame: 6 months
Proportion of patients having a myocardial revascularization
Time frame: 3 months
Description of adverse events regarding to the coronary artery calcium score
Time frame: 6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
Victor ABOYANS, MD principal investigator
University Hospital, Limoges
Tessa BERGOT study director
Société Française de la Cardiologie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Cardiovascular Diseases, run by French Cardiology Society at 9 sites 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 10 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: withdrawn, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportions of diabetic patients with high coronary artery calcium score (time frame: day 1). 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 17 Feb 2026.