NCT02641678

Brief Summary

Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies:

  1. 1.How many stroke patients with atrial fibrillation are missed by standard stroke unit 24h- electrocardiography, and
  2. 2.what is the effectiveness of the extended invasive and non-invasive ECG analysis tools to detect atrial fibrillation in stroke patients?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration 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

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

December 22, 2015

Last Update Submit

January 20, 2016

Conditions

Atrial FibrillationStroke

Keywords

Atrial Fibrillationstrokeimplantable cardiac monitorautomated ECG analysis

Outcome Measures

Primary Outcomes (1)

  • To determine the prevalence of undiagnosed AF in stroke patients undergoing the diagnostic standard (24h-ECG)

    Based on the obtained data, the prevalence (in percent) of undiagnosed AF in stroke patients whom AF is missed by the standard diagnostic procedure (24h-ECG) will be determined by different extensive non-invasive and invasive ECG monitoring tools

    7.5 months

Secondary Outcomes (1)

  • Diagnostic accuracy of the automated software based ECG analysis in comparison to the "gold-standard" the implanted cardiac monitor

    7.5 months

Other Outcomes (2)

  • Diagnostic accuracy of the automated software based ECG analysis in comparison to the standard methods (routine ECG, 24h longterm ECG)

    7.5 months

  • Cost efficacy of the different methods (automated software based ECG analysis and implantable cardiac monitor)

    7.5 months

Interventions

Implantation of cardiac monitorDEVICE

In patients with kryptogenic stroke, a cardiac monitor was implanted to detect atrial fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stroke of unknown etiology

You may qualify if:

  • Patients years with acute ischemic stroke of unknown cause, monitored on a stroke unit undergoing routine diagnostic procedures (conventional 12-lead-ECG, 24h-ECG, echocardiography, cCT or cMRI, Transcranial Doppler and carotid duplex ultrasound, long-term blood pressure monitoring, standard laboratory investigations)

You may not qualify if:

  • Stroke with known etiology, Stroke caused by intracranial hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bettin M, Dechering D, Kochhauser S, Bode N, Eckardt L, Frommeyer G, Reinke F. Extended ECG monitoring with an implantable loop recorder in patients with cryptogenic stroke: time schedule, reasons for explantation and incidental findings (results from the TRACK-AF trial). Clin Res Cardiol. 2019 Mar;108(3):309-314. doi: 10.1007/s00392-018-1358-4. Epub 2018 Aug 22.

    PMID: 30167809DERIVED

  • Reinke F, Bettin M, Ross LS, Kochhauser S, Kleffner I, Ritter M, Minnerup J, Dechering D, Eckardt L, Dittrich R. Refinement of detecting atrial fibrillation in stroke patients: results from the TRACK-AF Study. Eur J Neurol. 2018 Apr;25(4):631-636. doi: 10.1111/ene.13538. Epub 2018 Feb 13.

    PMID: 29205690DERIVED

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Dittrich Ralf, MD

    Department of Neurology, University of Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 29, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share