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Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02610803
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Kristina Hoeg Vinther, Odense University Hospital

November 13, 2015
November 20, 2015
November 20, 2015
September 2014
September 2015   (Final data collection date for primary outcome measure)
Time to death or recurrent stroke [ Time Frame: Up to 4 years ]
Same as current
No Changes Posted
  • Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry [ Time Frame: up to 2 days ]
  • Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry [ Time Frame: up to 2 days ]
  • 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 ]
  • 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) ]
Same as current
Not Provided
Not Provided
 
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients with acute ischemic stroke, admitted to our hospital between August 2008-April 2011
  • Ischemic Stroke
  • Paroxysmal Atrial Fibrillation
  • Premature Atrial Complexes
Not Provided
Patients with ischemic stroke
Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
863
Same as current
October 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Hemorrhagic stroke
  • No Danish civil registration
  • no permanent address in Denmark during follow-up.
  • patients with lack of telemetry data
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT02610803
HISPACs
No
Not Provided
Not Provided
Kristina Hoeg Vinther, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Kristina H Vinther, MD
Odense University Hospital
November 2015