Assessing heart-related risks in patients with type 2 diabetes
Prospective Observational Study on the Predictive Value of Cardiac Damage Markers High-sensitivity Cardiac Troponin I (Hs-cTnI), N-terminal Pro-B-natriuretic Peptide (NT-proBNP) and Soluble Suppression of Tumorigenesis-2 (sST2) for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV).
Istituto Nazionale di Ricovero e Cura per Anziani · NCT06902857
This study is trying to see if certain heart-related blood tests can help predict health risks for people with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1002 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani (other) |
| Locations | 1 site (Ancona) |
| Trial ID | NCT06902857 on ClinicalTrials.gov |
What this trial studies
The Diabetes-CV study is an observational study that evaluates the prognostic value of specific serum cardiac markers, including high-sensitivity cardiac troponin I, N-terminal pro-B-natriuretic peptide, and soluble suppression of tumorigenesis-2, in predicting mortality and cardiovascular events in patients with type 2 diabetes. Conducted at the IRCCS INRCA Hospital in Ancona, Italy, this single-center study will analyze clinical and laboratory data from patients attending the Diabetology Unit. The aim is to identify potential risk factors that could help in managing and preventing complications associated with diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with type 2 diabetes who are attending outpatient services.
Not a fit: Patients with type 1 diabetes, active cancer, or those who have had cancer in remission for less than 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict cardiovascular risks in patients with type 2 diabetes, leading to better management and prevention strategies.
How similar studies have performed: Other studies have shown promise in using cardiac markers to predict cardiovascular risks in diabetic populations, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * type 2 diabetes * patients attending the outpatient services Exclusion Criteria: * type 1 diabetes * patients with active cancer or cancer in remission for less than 5 years * any medical or other reason that leads the investigator to consider the subject ineligible for the study.
Where this trial is running
Ancona
- IRCCS INRCA Hospital — Ancona, Italy (RECRUITING)
Study contacts
- Principal investigator: Elena Tortato, MD — IRCCS INRCA, Ancona, Italy
- Study coordinator: Anna Rita Bonfigli, PhD
- Email: a.bonfigli@inrca.it
- Phone: 0718003719
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.
Conditions: Type 2 Diabetes, Cardiovascular Complication, type 2 diabetes, high-sensitivity cardiac troponin I, N-terminal pro-B-natriuretic peptide, soluble suppression of tumorigenesis-2, mortality risk, diabetes complications