Clinical trial NCT05314140: Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study
Official title: Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Keywords: Coronary artery calcium score
Heart failure risk factors
Prevention
Guidelines
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: CEBIMER
First posted: 2022-04-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportions of diabetic patients with high coronary artery calcium score
timeFrame: day 1
Secondary outcomes:
measure: Proportion of patients having a coronary exploration
timeFrame: 6 months
measure: Proportion of patients having a myocardial revascularization
timeFrame: 3 months
measure: Description of adverse events regarding to the coronary artery calcium score
timeFrame: 6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Limoges
country: France
facility: CHU de Limoges
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Lariboisière, APHP
city: Paris
country: France
facility: Hopital Saint Antoine
city: Poitiers
country: France
facility: CHU de Poitiers
city: Saint-Denis
country: France
facility: CHU de la Réunion
city: Thionville
country: France
facility: Centre de Cardiologie de Thionville
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital, Limoges
name: Victor ABOYANS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Société Française de la Cardiologie
name: Tessa BERGOT
role: STUDY_DIRECTOR
References: