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Completed

NCT Number: NCT02180542

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. time to death and recurrent stroke

    Time frame: Up to 4 years

Secondary outcomes

  1. Time to death, recurrent stroke and atrial fibrillation

    Time frame: Up to 4 years

  2. Left atrial volume and function estimated by echocardiography

    Time frame: baseline

    descriptive comparison in between groups.

Other outcomes

  1. biochemical markers

    Time frame: baseline

    descriptive comparison in between groups

  2. Plaque analysis i the carotid arteries on CT

    Time frame: baseline

    descriptive comparison in between groups.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Acronym: Pacific

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 2, 2014
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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