Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)

Istituto Nazionale di Ricovero e Cura per Anziani1,002 enrolled

Overview

The Diabetes-CV study is an observational study designed to assess the prognostic value of serum 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) in predicting mortality, major adverse cardiovascular events, and diabetic complications in patients with type 2 diabetes.

This single-center, investigator-initiated, prospective observational study aims to evaluate the prognostic value of serum cardiac damage markers such as high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP) and soluble suppression of tumorigenesis-2 (sST2) in subjects with type 2 diabetes. The study will utilize clinical and laboratory data from patients attending the Diabetology Unit at the IRCCS INRCA Hospital in Ancona (Italy), including both study-specific data and information extracted from routine outpatient medical records.

Study Type

OBSERVATIONAL

Enrollment

1,002

Conditions

Type 2 Diabetes Cardiovascular Complication

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The occurrence of all-cause mortality

Death from any cause

Time frame: From date of enrollment up to 36 months

Secondary Outcomes

Change in high-sensitivity cardiac troponin I levels

The levels of high-sensitivity cardiac troponin I will be analyzed.

Time frame: At enrollment and 36 months later

The occurence of cardiovascular events

Non-fatal cardiovascular events

Time frame: From date of enrollment up to 36 months

The Incidence of new diabetic complications

The onset of new micro and macrovascular complications of diabetes will be recorded

Time frame: From date of enrollment up to 36 months

Change in soluble suppression of tumorigenesis-2 levels

The levels of soluble suppression of tumorigenesis-2 will be analyzed.

Time frame: From date of enrollment up to 36 months

Change in N-terminal pro-B-natriuretic peptide levels

The levels of N-terminal pro-B-natriuretic peptide will be analyzed.

Time frame: From date of enrollment up to 36 months

Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts