Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations

Study Overview
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Brief Summary
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The aim of the study is to compare ESC recommendations on cardiovascular (CV) risk stratification with the achievement of a CAC (Coronary Artery Calcification). The development of a CAC, currently not systematically offered to these patients to refine CV risk, could make it possible to offer more intensive management of CV risk facors for patients who objectively have a high CV risk as evidenced by a high coronary calcium score. LDL target recommandations have become more aggressive with a very high level of evidence in type 2 diabetic patients but low in type 1 diabetic patients because there is no specific CV intervention study for T1D patients. These recommendations have far-reaching consequences because they would justify introducing in young type 1 diabetic patients, considered from the outset to be at moderate cardiovascular risk (young T1DM <35 years old) or even at high cardiovascular risk (duration of diabetes > 10 years) or very high cardiovascular risk (duration of diabetes > 20 years), treatment with statins or even aspirin, based only on the length of time they have had diabetes. The realization of a CAC, currently not systematically offered to these patients to refine CV risk, could make it possible to propose a more intensive management of CV risk factors for patients with objectively high CV risk attested by a high coronary calcium score. In this case the introduction of treatment with statins would be indicated.

Official Title
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Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations

Conditions
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Type 1 Diabetes, Coronary Artery Calcification

Intervention / Treatment
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* Diagnostic Test: Coronary Artery Calcification Realization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years and ≤ 35 years; Type 1 diabetic patient (defined by T1DM antibody positivity or onset in pediatric age); In primary cardiovascular prevention (with no CV events); Patient not treated by statins; Duration of diabetes > 5 years; Equipped with a continuous interstitial glucose measurement system for at least 14 days; No previous CAC performed Patient with social security or with third party coverage. Free subject, without guardianship or curatorship or subordination; Informed consent signed by the patient after clear and fair information about the study. Exclusion Criteria: Cardiovascular secondary prevention patients (with a previous CV event); ECG abnormality suggestive of coronary ischemia; Intolerance or contraindication to statins Person benefiting from reinforced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations; Pregnant and/or breastfeeding woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary Artery Calcification Evaluation<br> | Diagnostic Test: Coronary Artery Calcification Realization<br>* Coronary Artery Calcification Realization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin prescription indication based on the patient's LDL cholesterol value and the LDL cholesterol target determined according to the cardiovascular risk level calculated with the coronary calcium score | The prescription indication is LDL-cholesterol levels above the target level defined according to the level of cardiovascular risk: Moderate< 1 g/l- High< 0.7g/l-Very high< 0.55 g/l Coronary calcium score classified according to a consensus of the French Society of Cardiology and the French speaking Society of Diabetology 2020 : Moderate CAC ≤ 10- High 11 ≤ CAC ≤ 100- Very high CAC >100 | 1 day | 
| Statin prescription indication based on the patient's LDL cholesterol value and the LDL cholesterol target determined according to the cardiovascular risk level according to the ESC/ESA 2019 recommendations | The prescription indication is LDL-cholesterol levels above the target level defined according to the level of cardiovascular risk: Moderate< 1 g/l- High< 0.7g/l-Very high< 0.55 g/l ESC/ESA 2019 LDL target recommendations are cited in the summary | 1 day |