NCT06211946

Brief Summary

The goal of this observational study is to compare the measurements of abdominal aorta width via palpation and point of care ultrasound imaging in healthy individuals. The main question\[s\] it aims to answer are:

  • Is there a measurement difference in abdominal aorta width in healthy individuals as measured by palpation and point of care ultrasound imaging?
  • Are palpation measurements and point of care ultrasound imaging measurements reliable when performed by physical therapy researchers? Participants will be asked to have their abdominal area be palpated around the umbilicus and will have ultrasound imaging performed over their abdominal aorta area. It is anticipated participation in the study will take less than 15 minutes. Subjects will be asked to return for a repeat visit within 1 month to determine reliability of measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 9, 2024

Last Update Submit

April 15, 2024

Conditions

Keywords

Physical TherapyAbdominal ScreeningUltrasound Imaging

Outcome Measures

Primary Outcomes (2)

  • Palpation Measurement

    Palpated width of abdominal aorta will be measured using a tape measure.

    at baseline and within 1 month later

  • Ultrasound Measurement

    Width of abdominal aorta will be measured using point of care ultrasound.

    at baseline and within 1 month later

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults over the age of 18

You may qualify if:

  • \- Healthy adults \> 18 years of age

You may not qualify if:

  • History of abdominal aortic aneurysm.
  • Individuals that are pregnant or trying to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55904, United States

Location

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Darren Calley, P.T., DScPT, OCS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 18, 2024

Study Start

January 25, 2024

Primary Completion

March 21, 2024

Study Completion

April 3, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations