Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

NCT ID: NCT05716568

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard contrast dose

Standard contrast dose administration

Group Type ACTIVE_COMPARATOR

Contrast dose reduction, CT-angiography

Intervention Type OTHER

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

Calculated contrast dose

Contrast dose by calculation

Group Type ACTIVE_COMPARATOR

Contrast dose reduction, CT-angiography

Intervention Type OTHER

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

Calculated contrast dose -50%

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

Group Type ACTIVE_COMPARATOR

Contrast dose reduction, CT-angiography

Intervention Type OTHER

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

Interventions

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Contrast dose reduction, CT-angiography

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geert Maleux, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Other Identifiers

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S58042

Identifier Type: -

Identifier Source: org_study_id

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