Clinical trial NCT04534530: Does Screening of Coronary Artery Disease an Efficient Public Health Strategy in Patients With Type 2 DIABetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: cost / efficiency ratio
French health data base
Ischemic heart disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 90000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the 3.3 million people treated pharmacologically for diabetes mellitus in France, at least 3 million would be T2DM. It can be assumed that at least 2.4 million are free from coronary heart disease. This survey also shows that arterial hypertension and dyslipidemia (the two main cardiovascular risk factors) are present respectively in 58% and 57% of T2DM patients, and renal, neuropathic, or retinal complications are present respectively in 10%, 11% and 8% of them. Therefore, it can be estimated that at least 90,000 T2DM patients would be eligible (at least 2 cardiovascular risk factors and one other vascular disease) to be included in the study.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Gestational diabetes,
* Secondary diabetes,
* Presence of ischemic heart disease (history or current disease): acute coronary syndrome, angina pectoris, unstable angina, or coronary revascularization,
* Visit to an emergency department for chest pain followed by admission to an intensive care unit for cardiology,
* Patients who have undergone one or more systematic screening examinations during the pre-selection phase.

Primary outcomes:
measure: Cost-effectiveness analysis of routine screening for ischemic heart disease in T2DM patients
timeFrame: 4 years after inclusion
Secondary outcomes:
measure: Cost/consequence analysis for ischemic heart disease in T2DM patients.
timeFrame: 4 years after inclusion
measure: Budget impact analysis for Health Insurance of the most efficient strategy
timeFrame: 4 years after inclusion
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital Haut-Leveque
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien BEZIN, Dr
role: STUDY_CHAIR
affiliation: USMR
name: Antoine BENARD, Dr
role: STUDY_CHAIR
References:
citation: Mohammedi K, Preaubert N, Cariou T, Rigalleau V, Foussard N, Piazza L, Bairras-Martin C, Couffinhal T, Bezin J, Benard A. Cost-effectiveness of screening of coronary artery disease in patients with type 2 DIABetes at a very high cardiovascular risk (SCADIAB study) rational and design. Cardiovasc Diabetol. 2021 Mar 13;20(1):63. doi: 10.1186/s12933-021-01253-2.