Assessing cardiovascular risk in Italian patients with type 1 diabetes
Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
This study is testing how to better understand heart disease risk in people with type 1 diabetes by looking at their overall health and eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Trial ID | NCT06290544 on ClinicalTrials.gov |
What this trial studies
This study involves a multicenter prospective collection of data to evaluate cardiovascular risk in patients with type 1 diabetes mellitus using the ESC/EASD guidelines and The Steno Type 1 Risk Engine algorithm. It aims to correlate cardiovascular disease risk with atherosclerosis and microvascular complications of diabetes, including retinopathy, nephropathy, and neuropathy. Participants will undergo various diagnostic procedures, including coronary CT scans and noninvasive ultrasonography, to assess cardiovascular health and risk factors. Additionally, nutritional habits will be evaluated through a Food Frequency Questionnaire and interviews with a nutritionist.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with type 1 diabetes mellitus.
Not a fit: Patients with type 2 diabetes mellitus, secondary diabetes, or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular risk assessment and management for patients with type 1 diabetes, potentially reducing their risk of cardiovascular diseases.
How similar studies have performed: Other studies have shown success in using similar cardiovascular risk assessment approaches in diabetic populations, indicating potential for meaningful insights in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus. * Age ≥ 18 years. * Signed Informed consent Exclusion Criteria: * Age \< 18 years. * Pregnancy in progress. * Type 2 diabetes mellitus. * Secondary diabetes
Where this trial is running
Milan and 1 other locations
- IRCCS Centro Cardiologico Monzino — Milan, Italy (Recruiting)
- Policlinico di Monza — Monza, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Stefano Genovese, MD — IRCCS Centro Cardiologico Monzino
- Study coordinator: Stefano Genovese, MD
- Email: stefano.genovese@cardiologicomonzino.it
- Phone: +390258002327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.