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

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ClinicalTrials.gov Identifier: NCT02273245
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

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


Condition or disease Intervention/treatment
Acute Aortic Syndrome Radiation: Thoracic aortogram CT

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is a Pre-contrast Scan Necesary to Diagnose Acute Aortic Syndrome?
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Group/Cohort Intervention/treatment
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
With and without contrast dye




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age<18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273245


Locations
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United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom, PL6 8BX
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
Investigators
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Study Director: Carl Roobottom, MBChB FRCP Plymouth Hospital NHS Trust

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Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT02273245     History of Changes
Other Study ID Numbers: 14/P/155
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes