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

French Cardiology Society

Status: Not yet enrolling

Conditions: Diabetes Mellitus; Cardiovascular Diseases

Treatments: Diagnostic Test: Coronary artery calcium score evaluation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05314140

2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Coronary artery calcium score evaluation

Description:

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

Treatment:

Diagnostic Test: Coronary artery calcium score evaluation