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Completed

NCT Number: NCT02273245

Is a Pre-contrast Scan Necesary to Diagnose Acute Aortic Syndrome?

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

About this study

AAS include: a tear in the wall of the main artery from the heart, bleeding directly into this wall, an ulcer in the wall, and excess dilatation and rupture of the main artery wall. These are also treated differently according to where they are in the length of the aorta. It is therefore important to identify precisely the subtype of AAS and its location to allow the clinician to manage the patient appropriately.

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. The one before the contrast is used to determine if there is bleeding within the wall, which would show up as white on this scan. It is currently accepted that the contrast in the artery itself would hide the presence of bleeding within the wall. The other causes are seen primarily on the contrast scan only. Every patient proceeds from the pre-contrast scan to the contrast scan, unless there is a contraindication to the intravenous dye.

The investigators own database search has shown that radiologists protocol the scans according to their own preference and experience (i.e. some do both scans, others the contrast scan only). There is conflicting advice from international professional bodies as to whether to perform the non-contrast scan every time.

Some studies have shown that although the pre-contrast scan is sensitive to picking up bleeding within the wall, it adds nothing more over an increased radiation dose to the patient.

The investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans to look for all 4 of these entities that make up AAS. The investigators also propose that not requiring the pre-contrast scan would have significant savings in patient radiation dose, scanner time, network resources and radiologist time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age<18

Treatment and study plan

Thoracic aortogram CT

Radiation

With and without contrast dye

Primary outcomes

  1. Blinded review

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2014
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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