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Completed

NCT Number: NCT05716568

Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.

For this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.

An in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.

A total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients requiring CT-angiography of the aorta as requested by clinician
  • For aneurysm detection or follow-up
  • Or for dissection follow-up
  • Thoraco-abdominal aorta or abdominal aorta

Exclusion criteria

  • Contra-indications for contrast administration (severe renal impairment or adverse reactions)
  • Previously endovascular repair of the aorta
  • Only thoracic aorta
  • No informed consent
  • Contrast injection at 4cc/second not possible

Treatment and study plan

Contrast dose reduction, CT-angiography

Other

Contrast dose reduction for CT-angiography in pre-operative aorta

Primary outcomes

  1. Reduction in contrast dose

    Time frame: Through study completion, an average of 1 year

    Reduction in contrast dose while maintaining image quality

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta: A Prospective Study Based on Patient Heart Rate and Body Surface Area Differences

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

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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