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

Last updated: March 29, 2022
Sponsor: French Cardiology Society
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Cardiovascular Disease

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05314140
2021-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Coronary asymptomatic patient
  • Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes formore 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

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 testavailable.
  • 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 theinformed consent form Participation in another biomedical research protocol is permitted

Study Design

Total Participants: 2000
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • CHU de Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • CHU de Limoges

    Limoges, 87000
    France

    Site Not Available

  • CHU de Nice

    Nice, 06000
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • Hôpital Lariboisière, APHP

    Paris, 75010
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86000
    France

    Site Not Available

  • CHU de la Réunion

    Saint-Denis, 97400
    France

    Site Not Available

  • Centre de Cardiologie de Thionville

    Thionville, 57100
    France

    Site Not Available

  • CHU de Tours

    Tours, 37000
    France

    Site Not Available

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