Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study (TOSCANA)

February 12, 2026 updated by: French Cardiology Society
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Limoges, France, 87000
        • CHU de Limoges
      • Nice, France, 06000
        • Chu de Nice
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75010
        • Hôpital Lariboisière, APHP
      • Poitiers, France, 86000
        • CHU De Poitiers
      • Saint-Denis, France, 97400
        • CHU de la réunion
      • Thionville, France, 57100
        • Centre de Cardiologie de Thionville
      • Tours, France, 37000
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Coronary artery calcium score evaluation
The evaluation of the coronary artery calcium score will be performed with chest CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients having a coronary exploration
Time Frame: 6 months
Number of patient with high coronary artery calcium (>400) score having a coronary exploration compared with patient with low coronary artery calcium score (<400)
6 months
Proportion of patients having a myocardial revascularization
Time Frame: 3 months
Number of patient with high coronary artery calcium score (>400) having a myocardial revascularization compared with patient with low coronary artery calcium score (<400)
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
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)
6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Novo Nordisk A/S
CEBIMER

Investigators

  • Principal Investigator: Victor ABOYANS, MD, University Hospital, Limoges
  • Study Director: Tessa BERGOT, Société Française de la Cardiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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