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

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

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.

Study Overview

• Status: Completed
• Conditions: 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:

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.

• Study Type: Observational
• Enrollment (Actual): 264

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: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ischemic stroke patients admitted to the hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ischemic stroke patients; Patients admitted with ischemic stroke from march 2012 to april 2014

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to death and recurrent stroke	Up to 4 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical markers	descriptive comparison in between groups	baseline
Plaque analysis i the carotid arteries on CT	descriptive comparison in between groups.	baseline

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (ESTIMATE): July 2, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; Ischemic stroke; left atrial function; carotid artery; Cerebral infarction; recurrent stroke; premature atrial complexes; heart rhythm monitoring; plaque morphology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Stroke; Ischemic Stroke; Atrial Fibrillation; Premature Birth; Atrial Premature Complexes
• Other Study ID Numbers: PACIFIC