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

NCT ID: NCT05314140

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-06-30

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Coronary artery calcium score evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Coronary artery calcium score evaluation

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

CEBIMER

UNKNOWN

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor ABOYANS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Tessa BERGOT

Role: STUDY_DIRECTOR

Société Française de la Cardiologie

Locations

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, , France

Countries

France

Central Contacts

Victor ABOYANS, MD

Role: CONTACT

vaboyans@live.fr

+33 5 55 05 89 53

Tessa BERGOT

Role: CONTACT

tessa.bergot@sfcardio.fr

+33 1 44 90 70 33

Facility Contacts

Thierry COUFFINHAL, MD

Role: primary

thierry.couffinhal@inserm.fr

Victor ABOYANS, MD

Role: primary

vaboyans@live.fr

Emile FERRARI, MD

Role: primary

ferrari.e@chu-nice.fr

Patrick HENRY, MD

Role: primary

patrick.henry@aphp.fr

Franck BOCCARA, MD

Role: primary

franck.boccara@aphp.fr

Luc CHRISTIAENS, MD

Role: primary

l.christiaens@chu-poitiers.fr

Jérôme CORRE, MD

Role: primary

jerome.corre@chu-reunion.fr

Serge KOWNATOR, MD

Role: primary

s.kownator@wanadoo.fr

Denis ANGOULVANT, MD

Role: primary

denis.angoulvant@univ-tours.fr

Other Identifiers

2021-01

Identifier Type: -

Identifier Source: org_study_id