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

Not yet recruiting

• Conditions: Cardiovascular Diseases; Diabetes Mellitus
• Interventions: Diagnostic Test: Coronary artery calcium score evaluation

• Registration Number: NCT05314140
• Lead Sponsor: French Cardiology Society

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.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Study Start: 2022-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary artery calcium score evaluation	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

Primary Outcome Measures

Name	Time	Method
Proportions of diabetic patients with high coronary artery calcium score	day 1	Number of patient with diabetes having a coronary artery calcium score higher than 400

Secondary Outcome Measures

Name	Time	Method
Proportion of patients having a coronary exploration	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)
Proportion of patients having a myocardial revascularization	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)
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	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)

Trial Locations

Locations (9)

CHU de Nice; 🇫🇷 Nice, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hopital Saint Antoine; 🇫🇷 Paris, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de la Réunion; 🇫🇷 Saint-Denis, France

Centre de Cardiologie de Thionville; 🇫🇷 Thionville, France

CHU de Tours; 🇫🇷 Tours, France

Hôpital Lariboisière, APHP; 🇫🇷 Paris, France