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

Atrial Fibrillation Clinical Trial

— HERA-FIB  

Official title:

High-Sensitivity Cardiac Troponin T in Patients Admitted to the Emergency Department With Atrial Fibrillation in the Era of Novel Oral Anticoagulants - Heidelberg Registry of Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03344237
• Other study ID #: HERA-FIB
• Status: Recruiting
• Start date: September 14, 2017
• Est. completion date: March 2020

Study information

• Verified date: September 2019
• Source: University Hospital Heidelberg
• Contact: Mehrshad Vafaie, Dr.med.Dr.med.univ.
• Phone: 00496221/56-8676
• Email: mehrshad.vafaie[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 2020
• Est. primary completion date: November 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• documented atrial fibrillation

• availability of at least one hsTnT measurement

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)		Follow up after at least 6 months
Primary	Vascular and non-vascular death		Follow up after at least 6 months
Primary	Nonfatal myocardial infarction		Follow up after at least 6 months
Primary	Stroke/systemic embolism		Follow up after at least 6 months
Secondary	Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism		Follow up after at least 6 months