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Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02383836
Recruitment Status : Unknown
Verified March 2015 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.

Condition or disease
Patent Foramen Ovale

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : August 2016



Primary Outcome Measures :
  1. Bubble Detection [ Time Frame: 3 minutes ]
    The amount of time until bubbles are detected will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for a TEE with bubble injection to rule out a cardiac source of brain emboli following an acute neurological embolic event.
Criteria

Inclusion Criteria:

  • Patients needing a TEE evaluation to rule out a cardiac source of brain emboli

Exclusion Criteria:

  • Patients unable to comply with protocol requirements
  • Patients unable or unwilling to sign informed consent

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): NCT02383836


Contacts
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Contact: David S Blondheim, MD 972-463-04488 davidb@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: David S Blondheim, MD    972-4-630-4488    davidb@hy.health.gov.il   
Principal Investigator: David S Blondheim, MD         
Sub-Investigator: Sergiu Shabbtai, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02383836    
Other Study ID Numbers: 0005-X14-HYMC
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015
Keywords provided by Hillel Yaffe Medical Center:
Patent Foramen Ovale
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