Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05314140

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
French Cardiology Society · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCoronary artery calcium score evaluationThe evaluation of the coronary artery calcium score will be performed with chest CT scan

Timeline

Start date
2025-01-01
Primary completion
2028-01-01
Completion
2028-01-01
First posted
2022-04-06
Last updated
2026-02-17

Locations

9 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05314140. Inclusion in this directory is not an endorsement.