Screening for heart disease 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
This study is testing if regular heart disease screening can help people with type 2 diabetes who are at high risk but don’t have any known heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT04534530 on ClinicalTrials.gov |
What this trial studies
This study assesses the efficiency of systematic screening for ischemic heart disease in patients with type 2 diabetes mellitus (T2DM) who are at very high cardiovascular risk but do not have known coronary heart disease. It utilizes data from the National Health Data System to evaluate the real-life implications of routine screening. The study aims to address the disparity between current health recommendations and clinical practices regarding screening for silent ischemic heart disease in asymptomatic diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 years and older with type 2 diabetes for at least 7 years and at least two cardiovascular risk factors.
Not a fit: Patients without type 2 diabetes or those who do not meet the age and risk factor criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients with type 2 diabetes by identifying heart disease earlier.
How similar studies have performed: Other studies have shown varying success with similar screening approaches, but this specific methodology is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pessac
- Hopital Haut-Leveque — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Kamel MOHAMMEDI, Pr
- Email: kamel.mohammedi@chu-bordeaux.fr
- Phone: 5 57 65 60 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.