NCT05283538Completed
Cardiovascular Risk Stratification in Young People With Type 1 Diabetes
Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 4 Jan 2022
- Start date
- 28 Mar 2022
- Primary completion date
- 28 Mar 2025
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT05283538
What you commit to
- Study type: Interventional
- Participants enrolled: 91
- From 28 Mar 2022 to the primary completion date, 28 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C.H.U. de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.