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CompletedNCT04963400Updated Apr 3, 2024

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

An observational study in Non-cardiac Disease, sponsored by University of Leipzig. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by University of Leipzig · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
177
Ages
50 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Non-cardiac Disease

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 177 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
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)

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
177 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Analysis of hs-cTnT serum concentration after discharge

  • 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 · Diagnostic Test: Analysis of hs-cTnT serum concentration after discharge

  • 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 · Diagnostic Test: Analysis of hs-cTnT serum concentration after discharge

Interventions

  • Diagnostic testAnalysis of hs-cTnT serum concentration at hospitalization

    Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization

  • Diagnostic testAnalysis of hs-cTnT serum concentration after discharge

    Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)

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What researchers measure

Primary outcomes

  1. Difference of the hs-cTnT concentration at hospitalization and after discharge

    Time frame: 60 days

Secondary outcomes

  1. Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of low severity

    Time frame: 60 days

  2. Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of medium severity

    Time frame: 60 days

  3. Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of high severity

    Time frame: 60 days

  4. Prediction of 1-year-mortality by hs-cTnT concentration

    Time frame: 1 year

  5. Prediction of 1-year-hospitalization rate due to a cardiovascular disease by hs-cTnT concentration

    Time frame: 1 year

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Study locations

1 site
  • University of Leipzig Medical Center
    Leipzig, 04103, Germany
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References and documents

Individual participant data

Plan to share: Undecided — Available upon reasonable scientific request

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04963400
Lead sponsor
University of Leipzig
Responsible party
Rolf Wachter (Professor MD, University of Leipzig) — Principal investigator
First posted
Jul 15, 2021
Start date
Jul 14, 2021
Primary completion
Jan 17, 2024
Completion
Jan 17, 2024
Last update
Apr 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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