NCT02383836

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 23, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 23, 2015

Last Update Submit

March 3, 2015

Conditions

Patent Foramen Ovale

Keywords

Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

  • Bubble Detection

    The amount of time until bubbles are detected will be measured

    3 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

David S Blondheim, MD

CONTACT

972-463-04488davidb@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 9, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

IL(1)