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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283538
• Other study ID #: CACD1
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: October 28, 2024

Study information

• Verified date: March 2024
• Source: Poitiers University Hospital
• Contact: Xavier PIGUEL
• Phone: 05 49 44 39 00
• Email: xavier.piguel[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 28, 2024
• Est. primary completion date: September 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Calcification
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Diagnostic Test:
• Coronary Artery Calcification Realization
Coronary Artery Calcification Realization

Locations

Country	Name	City	State
France	C.H.U. de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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