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

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ClinicalTrials.gov Identifier: NCT02180542
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Kristina Hoeg Vinther, Odense University 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.

Condition or disease
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
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 : March 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. time to death and recurrent stroke [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ischemic stroke patients admitted to the hospital
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.

Information from the National Library of Medicine

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): NCT02180542


Locations
Denmark
Department of Medical Research, OUH, Svendborg
Svendborg, Funen, Denmark, 5700
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Kristina H Vinther, MD

Responsible Party: Kristina Hoeg Vinther, Medical Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02180542     History of Changes
Other Study ID Numbers: Pacific
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Kristina Hoeg Vinther, Odense University Hospital:
stroke
Ischemic stroke
Cerebral infarction
recurrent stroke
atrial fibrillation
premature atrial complexes
heart rhythm monitoring
left atrial function
carotid artery
plaque morphology

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Premature Birth
Atrial Premature Complexes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature