- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351076
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
September 7, 2016 updated by: University Hospital Ostrava
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient. Pilot Study.
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ostrava, Czech Republic, 70200
- University Hospital Ostrava
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patient after ischemic stroke including TIA, age 18-55 year
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection of right-to-left shunt
Time Frame: 1 week
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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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1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Kuliha, MD, University Hospital Ostrava
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
November 23, 2014
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 30, 2015
Study Record Updates
Last Update Posted (Estimate)
September 8, 2016
Last Update Submitted That Met QC Criteria
September 7, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RVO-FNOs/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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