NCT02610803

Brief Summary

The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
863

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 13, 2015

Last Update Submit

November 19, 2015

Conditions

Keywords

strokeischemic strokerecurrent strokeatrial fibrillationpremature atrial complexesheart rhythm monitoringcardiac telemetry

Outcome Measures

Primary Outcomes (1)

  • Time to death or recurrent stroke

    Up to 4 years

Secondary Outcomes (4)

  • Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry

    up to 2 days

  • Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry

    up to 2 days

  • Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.

    Up to 4 years

  • Number of patients with atrial fibrillation having oral anticoagulant treatment at discharge. Data will be extracted from the Danish Stroke Registry.

    to the day of discharge (up to 4 weeks)

Study Arms (1)

Patients with ischemic stroke

Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke, admitted to our hospital between August 2008-April 2011

You may qualify if:

  • admitted with ischemic stroke from August 2008-April 2011
  • Registered in the Danish Stroke Registry

You may not qualify if:

  • Hemorrhagic stroke
  • No Danish civil registration
  • no permanent address in Denmark during follow-up.
  • patients with lack of telemetry data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, OUH, Svendborg

Svendborg, Funen, 5700, Denmark

Location

MeSH Terms

Conditions

Ischemic StrokeAtrial FibrillationAtrial Premature ComplexesStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Complexes, PrematureCardiac Conduction System Disease

Study Officials

  • Kristina H Vinther, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 20, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations