Focused Cardiac Ultrasound
Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
1 other identifier
interventional
47
1 country
1
Brief Summary
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedResults Posted
Study results publicly available
June 16, 2020
CompletedJune 16, 2020
May 1, 2020
2 months
March 21, 2019
May 30, 2020
May 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
Day 1
Study Arms (1)
treatment group
EXPERIMENTALAll participants to receive standard transthoracic echocardiogram and hand held echocardiogram
Interventions
Portable hand-held ultrasound device
Eligibility Criteria
You may qualify if:
- Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
- Willing and able to provide informed consent or assent.
- In clinically stable condition as assessed by the principal investigator..
- With adequate echocardiographic windows.
You may not qualify if:
- Patients with poor echocardiographic windows.
- Patients who refuse informed consent.
- Pregnant women.
- Prisoners.
- Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jackson Memorial Hospital
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Sokoloski
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Sokoloski, M.D.
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 22, 2019
Study Start
April 1, 2019
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
June 16, 2020
Results First Posted
June 16, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share