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
|Condition or disease|
|Ischemic Stroke Paroxysmal Atrial Fibrillation Premature Atrial Complexes|
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|
|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|
Patients with ischemic stroke
Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined).
- Time to death or recurrent stroke [ Time Frame: Up to 4 years ]
- Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry [ Time Frame: up to 2 days ]
- Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry [ Time Frame: up to 2 days ]
- 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 ]
- 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) ]
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
|Department of Medical Research, OUH, Svendborg|
|Svendborg, Funen, Denmark, 5700|
|Principal Investigator:||Kristina H Vinther, MD|