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CompletedNCT02610803Updated Nov 20, 2015

Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke

An observational study in Ischemic Stroke, Paroxysmal Atrial Fibrillation and Premature Atrial Complexes, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by Odense University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
863
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.

Read the detailed description

Stroke is the second leading cause of death worldwide and it is well known that atrial fibrillation(AF) is a major risk factor for ischemic stroke. Paroxysmal AF can be difficult to detect because many cases are asymptomatic. In recent years prolonged cardiac rhythm monitoring of patients with ischemic stroke has showed an underestimated prevalence of AF. However, no optimal monitoring strategy is implemented in the clinic yet. This is the reason why research currently is focused on finding predictive risk markers of AF. Cohort studies of healthy individuals and stroke patients have shown that excessive premature atrial complexes (PACs) and brief runs of PACs are an emerging risk marker in helping to identifying patients in risk of having or developing AF. Despite this brief runs of PACs less than 30 s are today in everyday clinical practice perceived to be of no clinical significance.

The study population of ischemic stroke patients have all without known AF underwent ECG and 48 hours' inpatient cardiac telemetry as a clinical routine. In the medical record it is registered if patients had runs of PACs or new diagnosed AF.

All patients are registered in the Danish Stroke Registry, and all the baseline data on patients will be obtained from the registry.

The follow-up end August 2015 and information on AF, recurrent stroke and death will be obtained from medical records and the Funen Patient Administrative System, which is linked to the national Civil Registration System.

The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of PACs and new diagnosed AF. Furthermore to evaluate the prognostic significance of brief runs of PACs in relation to develop AF and the prognostic significance of brief runs of PACs and AF in relation to recurrent stroke and death.

02

Conditions studied

  • Ischemic Stroke
  • Paroxysmal Atrial Fibrillation
  • Premature Atrial Complexes

Keywords

  • stroke
  • ischemic stroke
  • recurrent stroke
  • atrial fibrillation
  • premature atrial complexes
  • heart rhythm monitoring
  • cardiac telemetry
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 863 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute ischemic stroke, admitted to our hospital between August 2008-April 2011

Inclusion criteria

  • admitted with ischemic stroke from August 2008-April 2011
  • Registered in the Danish Stroke Registry

Exclusion criteria

Exclusion Criteria:

  • Hemorrhagic stroke
  • No Danish civil registration
  • no permanent address in Denmark during follow-up.
  • patients with lack of telemetry data
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
863 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with ischemic stroke

    Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined).

06

What researchers measure

Primary outcomes

  1. Time to death or recurrent stroke

    Time frame: Up to 4 years

Secondary outcomes

  1. Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry

    Time frame: up to 2 days

  2. Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry

    Time frame: up to 2 days

  3. Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.

    Time frame: Up to 4 years

  4. Number of patients with atrial fibrillation having oral anticoagulant treatment at discharge. Data will be extracted from the Danish Stroke Registry.

    Time frame: to the day of discharge (up to 4 weeks)

07

Study locations

1 site
  • Department of Medical Research, OUH, Svendborg
    Svendborg, Funen 5700, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02610803
Lead sponsor
Odense University Hospital
Responsible party
Kristina Hoeg Vinther (Medical Doctor, Odense University Hospital) — Principal investigator
First posted
Nov 20, 2015
Start date
Sep 2014
Primary completion
Sep 2015
Completion
Oct 2015
Last update
Nov 20, 2015

Study contacts

Kristina H Vinther, MD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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