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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

Brief 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.

Condition or disease
Ischemic Stroke Paroxysmal Atrial Fibrillation Premature Atrial Complexes

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.


Study Type : Observational
Actual Enrollment : 863 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Time to death or recurrent stroke [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610803


Locations
Denmark
Department of Medical Research, OUH, Svendborg
Svendborg, Funen, Denmark, 5700
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Kristina H Vinther, MD

Responsible Party: Kristina Hoeg Vinther, Medical Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02610803     History of Changes
Other Study ID Numbers: HISPACs
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Kristina Hoeg Vinther, Odense University Hospital:
stroke
ischemic stroke
recurrent stroke
atrial fibrillation
premature atrial complexes
heart rhythm monitoring
cardiac telemetry

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Ischemia
Premature Birth
Cerebral Infarction
Atrial Premature Complexes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Brain Infarction
Brain Ischemia
Cardiac Complexes, Premature