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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 863

Contacts and Locations

Study Locations

• Denmark
  • Funen
    • Svendborg, Funen, Denmark, 5700
      • Department of Medical Research, OUH, Svendborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to death or recurrent stroke	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry	up to 2 days
Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry	up to 2 days
Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.	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.	to the day of discharge (up to 4 weeks)

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; ischemic stroke; recurrent stroke; premature atrial complexes; heart rhythm monitoring; cardiac telemetry
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Brain Ischemia; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infarction; Brain Infarction; Cardiac Complexes, Premature; Stroke; Ischemic Stroke; Ischemia; Atrial Fibrillation; Premature Birth; Cerebral Infarction; Atrial Premature Complexes
• Other Study ID Numbers: HISPACs