Pacific: Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02180542

Collaborator

University of Southern Denmark (Other)

264

Enrollment

Location

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to improve secondary prevention of ischemic stroke patients by

Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
Characterize ischemic stroke patients by
Echocardiographic characteristics
Biochemical markers
Plaque composition in the carotid arteries

in order to improve risk stratification.

Condition or Disease	Intervention/Treatment	Phase
Stroke Atrial Fibrillation Premature Atrial Complexes

Detailed Description

Patients with atrial fibrillation (AF) have a five-fold increased risk of ischemic stroke compared to the general population. Identifying AF can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of AF. Therefore it is important to identify predictors of AF to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. Few former studies have shown an association between excessive numbers of premature atrial complexes (PACs) and AF.

The study population of ischemic stroke patients will at admission undergo following examinations:

ECG
48 hours inpatient cardiac telemetry (If not known AF)
24 hours holter monitoring (if not known AF)
echocardiogram
blood sample
CT scan of carotid arteries with contrast made on Dual Energy CT scan.

In the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) It will be noticed if patients have any recurrent events, die og developing AF.

The study population will be divided into four groups as follows:

patients with new AF at admission
patients with known AF
patients with frequent PACs
patients without frequent PACs. These groups will be compared on baseline characteristics and on outcome as mentioned.

The overall perspective is to make better strategies for detecting occult AF after ischemic stroke to improve secondary stroke prevention care.

Study Design

Study Type:

Observational

Actual Enrollment :

264 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke: Prevalence, Characteristics and Prognosis

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Ischemic stroke patients Patients admitted with ischemic stroke from march 2012 to april 2014

Outcome Measures

Primary Outcome Measures

time to death and recurrent stroke [Up to 4 years]

Secondary Outcome Measures

Time to death, recurrent stroke and atrial fibrillation [Up to 4 years]
Left atrial volume and function estimated by echocardiography [baseline]
descriptive comparison in between groups.

Other Outcome Measures

biochemical markers [baseline]
descriptive comparison in between groups
Plaque analysis i the carotid arteries on CT [baseline]
descriptive comparison in between groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

admitted with ischemic stroke at a single center
time from diagnose to inclusion maximum 7 days.
written informed consent or surrogate informed consent eligible
age > 18 years.

Exclusion Criteria:

hemorrhagic stroke
terminal illness and expected lifespan of less than 6 months.
any physical or mental condition which make the patients unsuitable for participation in the study.
known with a pacemaker
anticoagulation treatment of other reasons than atrial fibrillation.