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

Primary Purpose

Type 1 Diabetes, Coronary Artery Calcification

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coronary Artery Calcification Realization
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • C.H.U. de PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary Artery Calcification Evaluation

Arm Description

Outcomes

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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
October 10, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05283538
Brief Title
Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations
Official Title
Comparison of Cardiovascular Risk Stratification in Young People With Type 1 Diabetes by Coronary Calcium Score to ESC/ESA2019 Recommendations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Coronary Artery Calcification

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary Artery Calcification Evaluation
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary Artery Calcification Realization
Intervention Description
Coronary Artery Calcification Realization
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
1 day
Title
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
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier PIGUEL
Phone
05 49 44 39 00
Ext
+ 33
Email
xavier.piguel@chu-poitiers.fr
Facility Information:
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier PIGUEL, MD
Phone
+33 5 49 44 39 00
Email
xavier.piguel@chu-poitiers.fr

12. IPD Sharing Statement

Learn more about this trial

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

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