Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity

Completed

• Conditions: Non-cardiac Disease
• Interventions: Diagnostic Test: Analysis of hs-cTnT serum concentration at hospitalization; Diagnostic Test: Analysis of hs-cTnT serum concentration after discharge

• Registration Number: NCT04963400
• Lead Sponsor: University of Leipzig

Brief Summary

We aim to examine, whether hospitalization is associated with higher high-sensitivity cardiac troponin T (hs-cTnT) serum concentrations in patients without a cardiac disease.

Detailed Description

High-sensitivity cardiac troponin T (hs-cTnT) values will be obtained in hospitalized patients a) without a diagnosed or suspected cardiac disease, and b) with an acute medical condition that is not commonly associated with an increase of hs-cTnT concentrations. As a reference, a second sampling of blood for an analysis of the hs-cTnT serum concentration will be obtained in the same patients after discharge (60 days after hospitalization).

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study Start: 2021-07-14
• Study First Posted: 2021-07-15
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• hospitalization due to a non-cardiac disease
• age ≥ 50 years

Exclusion Criteria

• diagnosed or suspected cardiac disease
• acute medical conditions commonly associated with a myocardial injury (e.g. circulatory shock, sepsis, pulmonary embolism, cerebral infarction, acute renal failure)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with high disease severity	Analysis of hs-cTnT serum concentration after discharge	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of high severity (e.g. patients with a proximal femoral fracture)
Patients with medium disease severity	Analysis of hs-cTnT serum concentration at hospitalization	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of medium severity (e.g. patients with an uncomplicated acute pancreatitis oder an acute exacerbation of a chronic inflammatory bowel disease)
Patients with medium disease severity	Analysis of hs-cTnT serum concentration after discharge	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of medium severity (e.g. patients with an uncomplicated acute pancreatitis oder an acute exacerbation of a chronic inflammatory bowel disease)
Patients with low disease severity	Analysis of hs-cTnT serum concentration at hospitalization	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of low severity (e.g. patients with retinal detachment)
Patients with low disease severity	Analysis of hs-cTnT serum concentration after discharge	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of low severity (e.g. patients with retinal detachment)
Patients with high disease severity	Analysis of hs-cTnT serum concentration at hospitalization	Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of high severity (e.g. patients with a proximal femoral fracture)

Primary Outcome Measures

Name	Time	Method
Difference of the hs-cTnT concentration at hospitalization and after discharge	60 days

Secondary Outcome Measures

Name	Time	Method
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of low severity	60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of medium severity	60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of high severity	60 days
Prediction of 1-year-mortality by hs-cTnT concentration	1 year
Prediction of 1-year-hospitalization rate due to a cardiovascular disease by hs-cTnT concentration	1 year

Trial Locations

Locations (1)

University of Leipzig Medical Center; 🇩🇪 Leipzig, Germany