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Completed

NCT Number: NCT02610803

Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Arrhythmias, Cardiac Atrial Fibrillation Atrial Premature Complexes Brain Diseases Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Atrial Complexes Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medical Research, OUH, Svendborg

Svendborg, Funen, 5700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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