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

September 26, 2019 updated by: Dr.med. Dr.med.univ. Mehrshad VAFAIE, University Hospital Heidelberg

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

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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular and non-vascular death
Time Frame: Follow up after at least 6 months
Follow up after at least 6 months
Nonfatal myocardial infarction
Time Frame: Follow up after at least 6 months
Follow up after at least 6 months
Stroke/systemic embolism
Time Frame: Follow up after at least 6 months
Follow up after at least 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Follow up after at least 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)
Time Frame: Follow up after at least 6 months
Follow up after at least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Investigators

  • Principal Investigator: Mehrshad Vafaie, Dr.med.Dr.med.univ., University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

November 11, 2017

First Submitted That Met QC Criteria

November 11, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERA-FIB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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