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Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contrast dose reduction, CT-angiography
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm focused on measuring CT-angiography, Aortic aneurysm, Aortic dissection, Pre-operative, Contrast dose reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Standard contrast dose

    Calculated contrast dose

    Calculated contrast dose -50%

    Arm Description

    Standard contrast dose administration

    Contrast dose by calculation

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

    Outcomes

    Primary Outcome Measures

    Reduction in contrast dose
    Reduction in contrast dose while maintaining image quality

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2015
    Last Updated
    January 27, 2023
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05716568
    Brief Title
    Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Aneurysm
    Keywords
    CT-angiography, Aortic aneurysm, Aortic dissection, Pre-operative, Contrast dose reduction

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard contrast dose
    Arm Type
    Active Comparator
    Arm Description
    Standard contrast dose administration
    Arm Title
    Calculated contrast dose
    Arm Type
    Active Comparator
    Arm Description
    Contrast dose by calculation
    Arm Title
    Calculated contrast dose -50%
    Arm Type
    Active Comparator
    Arm Description
    Contrast dose by calculation, with extra dilution by 50%.
    Intervention Type
    Other
    Intervention Name(s)
    Contrast dose reduction, CT-angiography
    Intervention Description
    Contrast dose reduction for CT-angiography in pre-operative aorta
    Primary Outcome Measure Information:
    Title
    Reduction in contrast dose
    Description
    Reduction in contrast dose while maintaining image quality
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Geert Maleux, Prof Dr
    Organizational Affiliation
    Universitaire Ziekenhuizen KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

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