CClinicalTrials.gg
Sign In
Status unknownNCT03344237HERA-FIBUpdated Sep 27, 2019

hsTnT in Patients Admitted to the ED With Atrial Fibrillation in the Era of NOACs - Heidelberg Registry of Atrial Fibrillation

An observational study in Atrial Fibrillation, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by University Hospital Heidelberg · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
5,000
Sex
All
01

Study summary

The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is 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 in the era of novel oral anticoagulants (NOACs).

02

Conditions studied

  • Atrial Fibrillation

Browse trials for

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017

Inclusion criteria

  • documented atrial fibrillation
  • availability of at least one hsTnT measurement

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
5,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Vascular and non-vascular death

    Time frame: Follow up after at least 6 months

  2. Nonfatal myocardial infarction

    Time frame: Follow up after at least 6 months

  3. Stroke/systemic embolism

    Time frame: Follow up after at least 6 months

Secondary outcomes

  1. Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism

    Time frame: Follow up after at least 6 months

Other outcomes

  1. Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)

    Time frame: Follow up after at least 6 months

06

Study locations

1 of 1 sites recruiting
  • Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital
    Heidelberg, Baden-Württemberg 69120, Germany
    • Mehrshad Vafaie, Dr.med.Dr.med.univ. · Contact
    • Kiril M Stoyanov, Dr.med. · Sub investigator
    • Hugo A Katus, Prof.Dr.med. · Sub investigator
    • Evangelos Giannitsis, Prof.Dr.med. · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03344237
Lead sponsor
University Hospital Heidelberg
Responsible party
Dr.med. Dr.med.univ. Mehrshad VAFAIE (Cardiologist, University Hospital Heidelberg) — Principal investigator
First posted
Nov 17, 2017
Start date
Sep 14, 2017
Primary completion
Nov 1, 2019 (estimated)
Completion
Mar 2020 (estimated)
Last update
Sep 27, 2019

Study contacts

Mehrshad Vafaie, Dr.med.Dr.med.univ.
Contact
mehrshad.vafaie@med.uni-heidelberg.de
00496221/56-8676
Mehrshad Vafaie, Dr.med.Dr.med.univ.
principal investigator · University Hospital Heidelberg

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 status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrial Fibrillation→

Other studies from this sponsor

University Hospital Heidelberg

Start the discussion