Clinical trial NCT02610803: Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
Official title: Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Paroxysmal Atrial Fibrillation
Premature Atrial Complexes
Keywords: stroke
ischemic stroke
recurrent stroke
atrial fibrillation
premature atrial complexes
heart rhythm monitoring
cardiac telemetry
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke, admitted to our hospital between August 2008-April 2011

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to death or recurrent stroke
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry
timeFrame: up to 2 days
measure: Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry
timeFrame: up to 2 days
measure: Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.
timeFrame: Up to 4 years
measure: Number of patients with atrial fibrillation having oral anticoagulant treatment at discharge. Data will be extracted from the Danish Stroke Registry.
timeFrame: to the day of discharge (up to 4 weeks)
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Department of Medical Research, OUH, Svendborg
state: Funen
Study officials:
name: Kristina H Vinther, MD
role: PRINCIPAL_INVESTIGATOR
References: