Non-cardiac DiseaseNCT04963400
Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity
An observational study of Non-cardiac Disease, run by University of Leipzig at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Non-cardiac Disease
- What is being tested?
- Analysis of hs-cTnT serum concentration at hospitalization and Analysis of hs-cTnT serum concentration after discharge
- How many people
- 177 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2021to 17 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 312 patients with an acute, non-cardiac medical condition of low, medium or high severity (104 patients per group)
Who may be able to join
- hospitalization due to a non-cardiac disease
- age ≥ 50 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
- Conditions
- Non-cardiac Disease
- Being tested
- Analysis of hs-cTnT serum concentration at hospitalization, Analysis of hs-cTnT serum concentration after discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of hs-cTnT serum concentration at hospitalizationDiagnostic test
Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization
Analysis of hs-cTnT serum concentration after dischargeDiagnostic test
Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Diagnostic Test: Analysis of hs-cTnT serum concentration at hospitalization; Diagnostic Test: Analysis of hs-cTnT serum concentration after discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the hs-cTnT concentration at hospitalization and after discharge
Measured: 60 days
Secondary outcomes (5)
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of low severity
Measured: 60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of medium severity
Measured: 60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of high severity
Measured: 60 days
Prediction of 1-year-mortality by hs-cTnT concentration
Measured: 1 year
Prediction of 1-year-hospitalization rate due to a cardiovascular disease by hs-cTnT concentration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start14 Jul 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Wachter, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963400
- Sponsor's protocol ID
- RL_2021_1
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable scientific request
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hospitalization on High-sensitivity Cardiac Troponin T Concentrations Depending on Disease Severity (Inpatient Troponin T)
- ClinicalTrials.gov ID
- NCT04963400
- Acronym / sponsor ID
- RL_2021_1
- Conditions
- Non-cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with low disease severity | – | Diagnostic Test: Analysis of hs-cTnT serum concentration at hospitalization, Diagnostic Test: Analysis of hs-cTnT serum concentration after dischargeHospitalized 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 medium disease severity | – | Diagnostic Test: Analysis of hs-cTnT serum concentration at hospitalization, Diagnostic Test: Analysis of hs-cTnT serum concentration after dischargeHospitalized 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 high disease severity | – | Diagnostic Test: Analysis of hs-cTnT serum concentration at hospitalization, Diagnostic Test: Analysis of hs-cTnT serum concentration after dischargeHospitalized 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 312 patients with an acute, non-cardiac medical condition of low, medium or high severity (104 patients per group)
Key inclusion criteria (2 listed)
- hospitalization due to a non-cardiac disease
- age ≥ 50 years
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of hs-cTnT serum concentration at hospitalizationAnalysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization | Diagnostic test | Patients with high disease severity, Patients with low disease severity, Patients with medium disease severity |
| Analysis of hs-cTnT serum concentration after dischargeAnalysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization) | Diagnostic test | Patients with high disease severity, Patients with low disease severity, Patients with medium disease severity |
Primary outcome
Difference of the hs-cTnT concentration at hospitalization and after discharge
Time frame: 60 days
5 secondary outcomes
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of low severity
Time frame: 60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of medium severity
Time frame: 60 days
Difference of the hs-cTnT concentration at hospitalization and after discharge in acute medical conditions of high severity
Time frame: 60 days
Prediction of 1-year-mortality by hs-cTnT concentration
Time frame: 1 year
Prediction of 1-year-hospitalization rate due to a cardiovascular disease by hs-cTnT concentration
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided. Available upon reasonable scientific request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cardiac Disease, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the hs-cTnT concentration at hospitalization and after discharge (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.