NCT02180542

Brief Summary

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

  1. 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. 2.Characterize ischemic stroke patients by
  3. 3.Echocardiographic characteristics
  4. 4.Biochemical markers
  5. 5.Plaque composition in the carotid arteries
  6. 6.in order to improve risk stratification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

July 1, 2014

Last Update Submit

October 10, 2017

Conditions

Keywords

strokeIschemic strokeCerebral infarctionrecurrent strokeatrial fibrillationpremature atrial complexesheart rhythm monitoringleft atrial functioncarotid arteryplaque morphology

Outcome Measures

Primary Outcomes (1)

  • time to death and recurrent stroke

    Up to 4 years

Secondary Outcomes (2)

  • Time to death, recurrent stroke and atrial fibrillation

    Up to 4 years

  • Left atrial volume and function estimated by echocardiography

    baseline

Other Outcomes (2)

  • biochemical markers

    baseline

  • Plaque analysis i the carotid arteries on CT

    baseline

Study Arms (1)

Ischemic stroke patients

Patients admitted with ischemic stroke from march 2012 to april 2014

Eligibility Criteria

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

Ischemic stroke patients admitted to the hospital

You may qualify if:

  • admitted with ischemic stroke at a single center
  • written informed consent or surrogate informed consent eligible
  • age \> 18 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, OUH, Svendborg

Svendborg, Funen, 5700, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

StrokeAtrial FibrillationAtrial Premature ComplexesIschemic StrokeCerebral Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kristina H Vinther, MD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 2, 2014

Study Start

March 1, 2012

Primary Completion

August 1, 2015

Study Completion

October 1, 2016

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations