Atrial FibrillationNCT02542189
High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)
An observational study of Atrial Fibrillation, run by University Hospital Heidelberg.
Trial summary
The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 3,037 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A cohort of approximately 3,500 consecutive patients presenting to the emergency department of the University Clinic Heidelberg between June 2009 and March 2013.
Who may be able to join
- documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission.
Who cannot join
- no patients are excluded.
About this study
The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular and non-vascular death
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
Measured: up to 60 months
nonfatal myocardial infarction
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
Measured: up to 60 months
stroke/transitory ischemic attack (TIA)
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 3,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hugo Katus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542189
- Sponsor's protocol ID
- S-377-2013
- Status last verified
- Sep 2015
- First submitted
- 6 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoyanov KM, Giannitsis E, Biener M, Mueller-Hennessen M, Arens K, Katus HA, Vafaie M. Prognostic value of elevated high-sensitivity cardiac troponin T in patients admitted to an emergency department with atrial fibrillation. Europace. 2018 Apr 1;20(4):582-588. doi: 10.1093/europace/eux063.
PubMed 28460039
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT02542189
- Acronym / sponsor ID
- S-377-2013
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,037 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of approximately 3,500 consecutive patients presenting to the emergency department of the University Clinic Heidelberg between June 2009 and March 2013.
Key inclusion criteria (1 listed)
- documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission.
Key exclusion criteria (1 listed)
- no patients are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular and non-vascular death
Time frame: up to 60 months
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
nonfatal myocardial infarction
Time frame: up to 60 months
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
stroke/transitory ischemic attack (TIA)
Time frame: up to 60 months
Assessment via review of inpatient- and outpatient visit reports, patient phone calls, postal queries with standardised questionnaires, contact with primary care physicians and resident registration office inquiries.
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 4 Sep 2015.
- Derived from this study: PubMed 28460039Stoyanov KM, Giannitsis E, Biener M, Mueller-Hennessen M, Arens K, Katus HA, Vafaie M. Prognostic value of elevated high-sensitivity cardiac troponin T in patients admitted to an emergency department with atrial fibrillation. Europace. 2018 Apr 1;20(4):582-588. doi: 10.1093/europace/eux063.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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, run by University Hospital Heidelberg.
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 1 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 4 Sep 2015. 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?
vascular and non-vascular death (time frame: up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542189, which also lists 1 linked publication.
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 4 Sep 2015.