Assessment of LVOT VTI in Healthy Volunteers
Reproducibility, Intra- and Inter-Observer Variability of Bedside Cardiac Ultrasound Measurements in the Assessment of Hemodynamic Parameters in Healthy Volunteers
1 other identifier
observational
30
1 country
1
Brief Summary
Healthy subjects will have transthoracic echocardiography evaluation of Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) performed by operators after brief training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2026
Shorter than P25 for all trials
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
May 6, 2026
CompletedStudy Start
First participant enrolled
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 22, 2026
May 1, 2026
8 months
May 6, 2026
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement between VTI measurements obtained by study participants and those obtained by an experienced operator.
Assessment using correlation coefficient, the intraclass correlation coefficient (ICC), and Bland-Altman analysis.
Day 2
Secondary Outcomes (3)
Assessment of inter-observer variability (inter-operator variability) of VTI measurements performed by fellows.
Day 2
Assessment of intra-observer variability (intra-operator variability) of VTI measurements.
Day 2
Assessment of time required to obtain a VTI measurement by participants.
Day 2
Study Arms (1)
Operator without experience in cardiac ultrasound examinations
Medical student at Medical University of Warsaw or licensed physician
Interventions
After brief training, operators will measure Velocity-Time Integral (in cm) of Left Ventricular Outflow Tract Obstruction in healthy volunteers.
Eligibility Criteria
Healthy volunteers without known structural heart disease, no history of atrial fibrillation, no aortic valve disease, and not pregnant.
You may qualify if:
- Age \> 18 years,
- Medical student at Medical University of Warsaw or licensed physician.
You may not qualify if:
- Age \< 18 years,
- Prior experience in performing cardiac ultrasound examinations, including acquisition of apical five- and three-chamber views and Doppler measurements of LVOT VTI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Warsaw
Warsaw, Poland
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Trzebicka, MD
Medical University of Warsaw
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
May 22, 2026
Study Start
May 11, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05