NCT05716568

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

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

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
7.2 years until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

December 15, 2015

Last Update Submit

January 27, 2023

Conditions

Aortic Aneurysm

Keywords

CT-angiographyAortic aneurysmAortic dissectionPre-operativeContrast dose reduction

Outcome Measures

Primary Outcomes (1)

  • Reduction in contrast dose

    Reduction in contrast dose while maintaining image quality

    Through study completion, an average of 1 year

Study Arms (3)

Standard contrast dose

ACTIVE COMPARATOR

Standard contrast dose administration

Other: Contrast dose reduction, CT-angiography

Calculated contrast dose

ACTIVE COMPARATOR

Contrast dose by calculation

Other: Contrast dose reduction, CT-angiography

Calculated contrast dose -50%

ACTIVE COMPARATOR

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

Other: Contrast dose reduction, CT-angiography

Interventions

Contrast dose reduction, CT-angiographyOTHER

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

Calculated contrast doseCalculated contrast dose -50%Standard contrast dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic AneurysmAortic Dissection

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Study Officials

  • Geert Maleux, Prof Dr

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

February 8, 2023

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 8, 2023

Record last verified: 2015-12