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: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• age greater than or equal to 40 years (on 2015/01/01),

• T2DM (ALD or hospitalization for T2DM or at least 3 deliveries of at least one oral or injectable anti-diabetic drug over a year (or 2 deliveries in the event of quarterly conditioning) without ALD or hospitalization for type 1 diabetes, secondary diabetes or diabetes gestational),

• Duration of diabetes greater than or equal to 7 years (the data available in the SNDS do not allow for an inclusion criterion of duration of diabetes\> 7 years) (identified in 2008),

• Patients with regular follow-up by a doctor (GP, cardiologist, endocrinologist) defined as having at least one contact per year (during the pre-selection period),

• Affiliated with the general health insurance scheme,

• With at least 2 cardiovascular risk factors: obesity (hospitalization for obesity or at least 3 deliveries of an anti-obesity drug over one year), high blood pressure (hospitalization for high blood pressure or at least 3 deliveries of at least one antihypertensive medication over one year), hypercholesterolemia (at least 3 prescriptions for statin and / or ezetimibe), or chronic obstructive pulmonary disease (used as an indicator of chronic tobacco poisoning; ALD or hospitalization for chronic obstructive pulmonary disease),

• And presenting at least one of the following organ damage (during the pre-selection period): a) Carotid stenosis (hospitalization for carotid stenosis or act of carotid revascularization); b) AIT (ALD or hospitalization for AIT); c) Stroke (ALD or hospitalization for stroke); d) Arteriopathy obliterating of the lower limbs (ALD or hospitalization for arteriopathy obliterating of the lower limbs); e) Chronic renal disease (ALD or hospitalization for diabetic nephropathy, chronic renal failure or recourse to a technique of replacement or renal transplantation); f) Severe diabetic retinopathy treated by laser photocoagulation (ALD or hospitalization for diabetic retinopathy associated with an act of laser photocoagulation); g) Peripheral or autonomic diabetic neuropathy (ALD or hospitalization for diabetic peripheral or autonomic neuropathy),

• Alive on 2015/01/01.

Locations
Other Locations
France
Hopital Haut-Leveque
RECRUITING
Pessac
Contact Information
Primary
Kamel MOHAMMEDI, Pr
kamel.mohammedi@chu-bordeaux.fr
5 57 65 60 78
Backup
Vincent RIGALLEAU, Pr
vincent.rigalleau@chu-bordeaux.fr
5 57 65 60 78
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2025-01
Participants
Target number of participants: 90000
Treatments
Experimental
The experimental group systematic screening for ischemic heart disease will be identified during the screening period by performing at least one systematic screening examination, regardless of the frequency, for ischemic heart disease in patients. diabetics at very high cardiovascular risk, without known coronary heart disease, by at least one non-invasive functional cardiovascular exploration outside the resting ECG.
Control
The control group Absence of systematic screening for ischemic heart disease will be identified during the pre-selection period by the absence of a non-invasive functional cardiovascular exploration (examinations mentioned above) in T2D with very high cardiovascular risk, with no known coronary heart disease, apart from performing a resting ECG
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov