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Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.

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ClinicalTrials.gov Identifier: NCT02351076
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years).

Condition or disease
Foramen Ovale Patent

Detailed Description:
The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years). Flow detection systém is a new method for right to left shunt detection comfortable for patients, not dependent on experienced examinator and only one method with exact valsalve maneuver measurement. Right to left shunt could be important etiology of cardioembolization in young stroke patient population, therefore screening for this condition is recommended in all young patient after ischemic stroke especially with unclear etiology. Flow detection systes seams to be ideal screening method for this patients.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient. Pilot Study.
Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016



Primary Outcome Measures :
  1. detection of right-to-left shunt [ Time Frame: 1 week ]
    Correletation of right-to-left shunt detection by 3 methods: transesophageal echocardiography, transcranial Doppler with contrast agent (microbubbles) and Flow detection system (Cardiox TM)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient after ischemic stroke including TIA, age 18-55 year
Criteria

Inclusion Criteria:ischemic stroke / TIA, signed informed consent -

Exclusion Criteria:imposibillity to undergo transesophageal echo, transcranial doppler with contrast or Cardiox flow detection system

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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): NCT02351076


Locations
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Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 70200
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Martin Kuliha, MD University Hospital Ostrava
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02351076    
Other Study ID Numbers: RVO-FNOs/2014
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities