Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

French Cardiology Society

Collaborating Sponsors:

Novo Nordisk A/S

CEBIMER

Conditions:

Diabetes Mellitus

Cardiovascular Diseases

Eligibility:

All Genders

18-70 years

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...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT05314140

Start Date

June 1 2022

End Date

June 30 2026

Last Update

April 6 2022

Active Locations (9)

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Page 1 of 3 (9 locations)

1

CHU de Bordeaux

Bordeaux, France, 33000

2

CHU de Limoges

Limoges, France, 87000

3

CHU de Nice

Nice, France, 06000

4

Hôpital Lariboisière, APHP

Paris, France, 75010