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CompletedNCT05716568Updated Feb 8, 2023

Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

An interventional study of Contrast dose reduction, CT-angiography in Aortic Aneurysm, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Aortic Aneurysm

Keywords

  • CT-angiography
  • Aortic aneurysm
  • Aortic dissection
  • Pre-operative
  • Contrast dose reduction
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Standard contrast dose

    Standard contrast dose administration

    Other: Contrast dose reduction, CT-angiography

  • Active comparator
    Calculated contrast dose

    Contrast dose by calculation

    Other: Contrast dose reduction, CT-angiography

  • Active comparator
    Calculated contrast dose -50%

    Contrast dose by calculation, with extra dilution by 50%.

    Other: Contrast dose reduction, CT-angiography

Interventions

  • OtherContrast dose reduction, CT-angiography

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

06

What researchers measure

Primary outcomes

  1. Reduction in contrast dose

    Reduction in contrast dose while maintaining image quality

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05716568
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Apr 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 8, 2023

Study contacts

Geert Maleux, Prof Dr
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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