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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-cardiac Disease
• Intervention / Treatment: Diagnostic test: Analysis of hs-cTnT serum concentration at hospitalization; Diagnostic test: Analysis of hs-cTnT serum concentration after discharge

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 Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

• Study Contact: Name: Rolf Wachter, MD; Phone Number: +493419711376; Email: rolf.wachter@medizin.uni-leipzig.de
• Study Contact Backup: Name: Romy Langhammer, MD; Phone Number: +493419711376; Email: romy.langhammer@medizin.uni-leipzig.de

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • University of Leipzig Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

312 patients with an acute, non-cardiac medical condition of low, medium or high severity (104 patients per group)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with low disease severity; Hospitalized patients without a diagnosed or suspected cardiac disease and with an acute medical condition of low severity (e.g. patients with retinal detachment)	Diagnostic test: Analysis of hs-cTnT serum concentration at hospitalization; Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization; Diagnostic test: Analysis of hs-cTnT serum concentration after discharge; Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)
Patients with medium disease severity; 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)	Diagnostic test: Analysis of hs-cTnT serum concentration at hospitalization; Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization; Diagnostic test: Analysis of hs-cTnT serum concentration after discharge; Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)
Patients with high disease severity; 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)	Diagnostic test: Analysis of hs-cTnT serum concentration at hospitalization; Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization; Diagnostic test: Analysis of hs-cTnT serum concentration after discharge; Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference of the hs-cTnT concentration at hospitalization and after discharge	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: RL_2021_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable scientific request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No