Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino
About this trial
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of type 1 diabetes mellitus.
Age ≥ 18 years.
Signed Informed consent
Disqualifiers
Age < 18 years.
Pregnancy in progress.
Type 2 diabetes mellitus.
Secondary diabetes
Trial design
Design model
Single group
Treatments tested in this trial
Standard of care plus additional examinations
Other interventionThe patient will undergo good clinical practice examinations according to guidelines plus The patient will undergo to the evaluation of endothelial dysfunction with ENDOPAT 2000 and whole blood sampling for future omics studies
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Single arm studyOther 1 intervention
Trial outcomes
Primary outcomes
1
Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration
Time frame
5 years2
Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).
Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm
Time frame
5 years3
Prevalence of cardiovascular disease in type 1 diabetes patients
Prevalence of cardiovascular disease in T1DM cohort defined as one of the following: * acute mycardial infarction * ischemic stroke * peripheral artery disease * coronary, carotid or peripheral artery revascularization * presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.
Time frame
5 yearsSecondary outcomes
1
Prevalence of diabetic retinopathy
Prevalence of diabetic retinopathy
Time frame
5 years2
Prevalence of diabetic nephropathy
Prevalence of diabetic nephropathy
Time frame
5 years3
Prevalence of diabetic neuropathy
Prevalence of diabetic neuropathy
Time frame
5 years4
CT-derived calcium score
CT-derived calcium score
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov