Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02610803
Collaborator
(none)
863
1
13
66.5

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Sep 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Oct 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with ischemic stroke

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

    Outcome Measures

    Primary Outcome Measures

    1. Time to death or recurrent stroke [Up to 4 years]

    Secondary Outcome Measures

    1. Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry [up to 2 days]

    2. Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry [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. [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. [to the day of discharge (up to 4 weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medical Research, OUH, Svendborg Svendborg Funen Denmark 5700

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Kristina H Vinther, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristina Hoeg Vinther, Medical Doctor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT02610803
    Other Study ID Numbers:
    • HISPACs
    First Posted:
    Nov 20, 2015
    Last Update Posted:
    Nov 20, 2015
    Last Verified:
    Nov 1, 2015

    Study Results

    No Results Posted as of Nov 20, 2015