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

Cardiovascular Diseases Clinical Trial

— TOSCANA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05314140
• Other study ID #: 2021-01
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2022
• Source: French Cardiology Society
• Contact: Victor ABOYANS, MD
• Phone: +33 5 55 05 89 53
• Email: vaboyans[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Coronary artery calcium score evaluation
The evaluation of the coronary artery calcium score will be performed with chest CT scan

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Limoges	Limoges
France	CHU de Nice	Nice
France	Hôpital Lariboisière, APHP	Paris
France	Hopital Saint Antoine	Paris
France	CHU de Poitiers	Poitiers
France	CHU de la Réunion	Saint-Denis
France	Centre de Cardiologie de Thionville	Thionville
France	CHU de Tours	Tours

Sponsors (3)

Lead Sponsor	Collaborator
French Cardiology Society	CEBIMER, Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	6 months
Secondary	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)	3 months
Secondary	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)	6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months