Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

January 27, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard contrast dose
Standard contrast dose administration
Other: Contrast dose reduction, CT-angiography
Contrast dose reduction for CT-angiography in pre-operative aorta
ACTIVE_COMPARATOR: Calculated contrast dose
Contrast dose by calculation
Other: Contrast dose reduction, CT-angiography
Contrast dose reduction for CT-angiography in pre-operative aorta
ACTIVE_COMPARATOR: Calculated contrast dose -50%
Contrast dose by calculation, with extra dilution by 50%.
Other: Contrast dose reduction, CT-angiography
Contrast dose reduction for CT-angiography in pre-operative aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in contrast dose
Time Frame: Through study completion, an average of 1 year
Reduction in contrast dose while maintaining image quality
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Geert Maleux, Prof Dr, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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