Atrial FibrillationTropo-AFNCT03683836
Minor Troponin Elevations in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation and Myocardial Ischemia, run by University of Turku.
Trial summary
This study aims at identifying the etiology of troponin-T elevations in patients with atrial fibrillation visiting the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Myocardial Ischemia
- How many people
- 3,394 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation admitted to Turku University Hospital emergency department
Who may be able to join
- two troponin T tests within 72 hours of ED admission
- Prior diagnosis of AF or AF at admission
Who cannot join
- Age < 18 years
About this study
Official title: Etiology of Minor Troponin Elevations in Patients With Atrial Fibrillation Visiting Emergency Department
This study aims at identifying the etiology of troponin-T elevations in patients with atrial fibrillation visiting the emergency department.
Read the detailed description
The aim of this study is to identify the factors associated with minor cardiac troponin-T elevations in patients presenting in emergency department (ED) with atrial fibrillation (AF) diagnosis , and the possible implications it has on the patients prognosis. Data on 3394 patients from the Turku university hospital catchment area with diagnosis of AF on admission to ED and minor troponin-T elevation were analyzed. Patients were classified into three groups according to the troponin-T value: troponin <15ng/l, 15-50ng/l and 51-100ng/l. Individual patient records were reviewed.
- Conditions
- Atrial Fibrillation, Myocardial Ischemia
- Being tested
- No intervention
- Medical subject headings
- Atrial Fibrillation, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality, myocardial infarction, ischemic stroke
Major adverse cardiac or cerebrovascular event within one year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jun 2016
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Retrospective
- Enrolment
- 3,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683836
- Sponsor's protocol ID
- T125/2016
- Acronym
- Tropo-AF
- Status last verified
- May 2024
- First submitted
- 22 Sep 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Minor Troponin Elevations in Patients With Atrial Fibrillation Visiting Emergency Department
- ClinicalTrials.gov ID
- NCT03683836
- Acronym / sponsor ID
- Tropo-AF / T125/2016
- Conditions
- Atrial Fibrillation, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,394 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 25 Sep 2018 (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.
This study aims at identifying the etiology of troponin-T elevations in patients with atrial fibrillation visiting the emergency department.
Detailed description
The aim of this study is to identify the factors associated with minor cardiac troponin-T elevations in patients presenting in emergency department (ED) with atrial fibrillation (AF) diagnosis , and the possible implications it has on the patients prognosis. Data on 3394 patients from the Turku university hospital catchment area with diagnosis of AF on admission to ED and minor troponin-T elevation were analyzed. Patients were classified into three groups according to the troponin-T value: troponin <15ng/l, 15-50ng/l and 51-100ng/l. Individual patient records were reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation admitted to Turku University Hospital emergency department
Key inclusion criteria (2 listed)
- two troponin T tests within 72 hours of ED admission
- Prior diagnosis of AF or AF at admission
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Study Group |
Primary outcome
All-cause mortality, myocardial infarction, ischemic stroke
Time frame: 12 months
Major adverse cardiac or cerebrovascular event within one 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 8 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Myocardial Ischemia, run by University of Turku.
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 1 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
All-cause mortality, myocardial infarction, ischemic stroke (time frame: 12 months). 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 8 May 2024.