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

Foramen Ovale Patent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351076
• Other study ID #: RVO-FNOs/2014
• Status: Completed
• Phase: N/A
• First received: November 23, 2014
• Last updated: September 7, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Foramen Ovale Patent
• Foramen Ovale, Patent

Locations

Country	Name	City	State
Czech Republic	University Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of right-to-left shunt	Correletation of right-to-left shunt detection by 3 methods: transesophageal echocardiography, transcranial Doppler with contrast agent (microbubbles) and Flow detection system (Cardiox TM)	1 week	No