CT TAVR Abdomen Study

ConditionTranscatheter Aortic Valve Replacement

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-88

SponsorUniversity of Maryland, Baltimore

About this trial

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

scheduled to receive TAVR abdominal CT

Disqualifiers

cannot undergo CT scan

Allergy to intravenous contrast not controlled by steroids or benadryl

GFR<30

Trial design

Design model

Single group

Treatments tested in this trial

Iodinated Contrast Agent (Omnipaque)
Combination product
Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.
Dual Energy CT
Device
Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Treatment groups

164 Participants

are divided into 2 treatment groups

Group A: Cohort 1Experimental treatment 2 interventions

Group B: Cohort 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Diagnostic Quality of Images

5-point Likert Scale

Time frame

18-24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

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