Type 1 DiabetesCACD1NCT05283538

Cardiovascular Risk Stratification in Young People With Type 1 Diabetes

A study testing Coronary Artery Calcification Realization in people with Type 1 Diabetes and Coronary Artery Calcification, run by Poitiers University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Type 1 Diabetes, Coronary Artery Calcification
What is being tested?: Coronary Artery Calcification Realization
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteFrance
Study dates: 28 Mar 2022to 28 Mar 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

C.H.U. de Poitiers
Poitiers, 86000

Other trials in France

About this study

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

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.

Conditions: Type 1 Diabetes, Coronary Artery Calcification
Being tested: Coronary Artery Calcification Realization
Keywords: cardio-vascular, c reactive protein
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronary Artery Calcification RealizationDiagnostic test
Coronary Artery Calcification Realization

Study groups in NCT05283538
Study group	Role	What they receive
Coronary Artery Calcification Evaluation	Experimental	Not described Receives: Diagnostic Test: Coronary Artery Calcification Realization

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Statin Prescription Indication Between Consensus of the French Society of Cardiology and the French Speaking Society of Diabetology 2020 and the ESC/EASD Consensus
Patients for whom the indication for prescribing statins for primary prevention would change if the CAC score were used as a diagnostic tool for cardiovascular risk instead of the 2019 ESC/EASD guidelines in patients with type 1 diabetes aged 18 to 35.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202228 Mar 2025

First posted17 Mar 2022
Study start28 Mar 2022
Primary completion28 Mar 2025
Study completion28 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05283538
Sponsor's protocol ID: CACD1
Acronym: CACD1
Status last verified: Jun 2026
First submitted: 4 Jan 2022
Last updated: 22 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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