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

NCT05314140 | Withdrawn

• 1 other identifier: 2021-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Keywords

Coronary artery calcium score; Heart failure risk factors; Prevention; Guidelines

Outcome Measures

Primary Outcomes (1)

• Proportions of diabetic patients with high coronary artery calcium score

  Number of patient with diabetes having a coronary artery calcium score higher than 400

  day 1

Secondary Outcomes (3)

• Proportion of patients having a coronary exploration

  6 months

• Proportion of patients having a myocardial revascularization

  3 months

• Description of adverse events regarding to the coronary artery calcium score

  6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months

Study Arms (1)

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

Interventions

Coronary artery calcium score evaluation DIAGNOSTIC_TEST

The evaluation of the coronary artery calcium score will be performed with chest CT scan

Coronary artery calcium score evaluation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: collaborator
• CEBIMER: collaborator
• French Cardiology Society: lead

Study Sites (9)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Limoges

Limoges, 87000, France

Location

CHU de Nice

Nice, 06000, France

Location

Hôpital Lariboisière, APHP

Paris, 75010, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU de la Réunion

Saint-Denis, 97400, France

Location

Centre de Cardiologie de Thionville

Thionville, 57100, France

Location

CHU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Victor ABOYANS, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

• Tessa BERGOT

  Société Française de la Cardiologie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (9)