NCT03479164

Brief Summary

The primary objective of this research project is development and validation of a new, non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic aneurysm in the chest and abdomen in at risk patients. This study would initially be performed in patients with a known aneurysm and done in addition to their indicated surveillance CT scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 30, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

March 7, 2018

Last Update Submit

July 15, 2019

Conditions

Aortic Aneurysm, ThoracicAortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of Ultra Low-Dose CT

    To assess the sensitivity of NCGA for aortic aneurysm in the thoracic or abdominal aorta

    Day of Scan

Secondary Outcomes (1)

  • Radiation Exposure of Ultra Low-Dose CT

    Day of Scan

Other Outcomes (2)

  • Assess Findings of Ultra Low-Dose CT

    Day of Scan

  • Optimize Automation of Ultra Low-Dose CT

    Day of Scan

Study Arms (1)

Ultra Low-Dose CT

EXPERIMENTAL

One non-contrast gated aortic (NCGA) computer tomography scan, a low radiation, non-contrast, low cost CT based study

Other: Ultra Low-Dose CT

Interventions

Ultra Low-Dose CTOTHER

Ultra Low-Dose CT

Ultra Low-Dose CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who carry the diagnosis of thoracic aortic aneurysm, aortic dissection, or abdominal aortic aneurysm and require CT imaging to evaluate the pathology

You may not qualify if:

  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota - Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Rumi Faizer, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 27, 2018

Study Start

March 30, 2016

Primary Completion

June 30, 2018

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)