NCT04534530

Does Screening of Coronary Artery Disease an Efficient Public Health Strategy in Patients With Type 2 DIABetes

Does Screening of Coronary Artery Disease an Efficient Public Health Strategy in Patients With Type 2 DIABetes at Very High Cardiovascular Risk: Target Trial Emulation From the National Healthcare System Claims Databases in France

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90,000 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of SCADIAB is to assess the real-life efficiency of systematic screening for ischemic heart disease in T2DM patients at very high cardiovascular risk, without known coronary heart disease, from the databases of the National Health Data System (SNDS).

Detailed description

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular and overall mortality. Cardiovascular disease is the leading cause of death, primarily ischemic heart disease, which is often early and can occur in asymptomatic diabetic patients, hence the potential benefit of routine screening to improve their cardiovascular prognosis. There is a notable disparity between the recommendations of the french High Authority of Health (HAS) and those of learned societies. The HAS does not recommend routine screening for silent ischemic heart disease in all asymptomatic T2DM patients without known coronary heart disease, apart from a resting electrocardiogram (ECG). Functional cardiovascular examinations should be reserved for situations of high cardiovascular risk, particularly the presence of history, clinical symptoms or ECG abnormalities in favor of cardiovascular disease. On the other hand, the main learned societies of diabetology and cardiology recommend systematic screening for silent ischemic heart disease in a larger T2DM population (age\> 60 years, duration of diabetes\> 10 years and at least 2 cardiovascular risk factors). In terms of current clinical practice, a majority of physicians prescribe screening for silent ischemic heart disease in diabetic patients by functional examinations (stress test, myocardial tomoscintigraphy coupled with a stress test, stress echocardiography) . The investigators carried out two surveys with fellow cardiologists and diabetologists in Bordeaux and at the national level which confirm this frequent practice of screening. The level of scientific evidence currently seems sufficient not to recommend systematic screening for silent ischemic heart disease in all diabetic patients. Four main randomized and controlled studies have not shown any benefit from this screening in terms of reducing major cardiovascular events in all T2DM patients. However, doubt remains in T2DM patients at very high cardiovascular risk, who may benefit from this strategy, but in whom no studies have been performed to date.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	Systematic screening for ischemic heart disease in type 2 diabetic patients	Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease.

Timeline

• Start date: 2023-06-05
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2020-09-01
• Last updated: 2026-01-15

Locations

1 site across 1 country: France