Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Coronary Artery Calcification Evaluation
|
Diagnostic Test: Coronary Artery Calcification Realization
Coronary Artery Calcification Realization
|
Outcome Measures
Primary Outcome Measures
- 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 [1 day]
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
- 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 [1 day]
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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CACD1