NCT02542189

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,037

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

6.1 years

First QC Date

August 6, 2015

Last Update Submit

September 2, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    up to 60 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission.

You may not qualify if:

  • no patients are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28460039DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC; FACC

Study Record Dates

First Submitted

August 6, 2015

First Posted

September 4, 2015

Study Start

June 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09