Clinical trial NCT02180542: Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.
Official title: Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke: Prevalence, Characteristics and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Premature Atrial Complexes
Keywords: stroke
Ischemic stroke
Cerebral infarction
recurrent stroke
atrial fibrillation
premature atrial complexes
heart rhythm monitoring
left atrial function
carotid artery
plaque morphology
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2014-07-02
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic stroke patients admitted to the hospital

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

1. Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
2. Characterize ischemic stroke patients by

   1. Echocardiographic characteristics
   2. Biochemical markers
   3. Plaque composition in the carotid arteries

      * in order to improve risk stratification.

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:

1. ECG
2. 48 hours inpatient cardiac telemetry (If not known AF)
3. 24 hours holter monitoring (if not known AF)
4. echocardiogram
5. blood sample
6. 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:

1. patients with new AF at admission
2. patients with known AF
3. patients with frequent PACs
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: time to death and recurrent stroke
timeFrame: Up to 4 years
Secondary outcomes:
measure: Time to death, recurrent stroke and atrial fibrillation
timeFrame: Up to 4 years
measure: Left atrial volume and function estimated by echocardiography
timeFrame: baseline
Other outcomes:
measure: biochemical markers
timeFrame: baseline
measure: Plaque analysis i the carotid arteries on CT
timeFrame: baseline
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: