NCT02273245

Brief Summary

Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest pain. There are several possible underlying causes, which cannot be distinguished from one another at the bedside. Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after. With the advancement of CT scanner technology, improvements in software interpretation and screen resolution, the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

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

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

October 21, 2014

Last Update Submit

November 4, 2015

Conditions

Acute Aortic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Blinded review

    2 experienced reporters are asked to blind view, in random order, either a contrast scan only, or a pair of pre- and post-contrast scans and report on an Excel spreadsheet.

    3 months

Study Arms (1)

thoracic aortgram CTs

A retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age\>18) patients presenting with symptoms of AAS.

Radiation: Thoracic aortogram CT

Interventions

Thoracic aortogram CTRADIATION

With and without contrast dye

thoracic aortgram CTs

Eligibility Criteria

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

A retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age\>18) patients presenting with symptoms of AAS.

You may qualify if:

  • male and female adult (age\>18) patients presenting with symptoms of AAS who had thoracic aortogram CTs.

You may not qualify if:

  • age\<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

MeSH Terms

Conditions

Acute Aortic Syndrome

Condition Hierarchy (Ancestors)

Aortic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Carl Roobottom, MBChB FRCP

    Plymouth Hospital NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

GB(1)