CT TAVR Abdomen Study

Study Overview
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Brief Summary
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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.

Official Title
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Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

Conditions
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Transcatheter Aortic Valve Replacement

Intervention / Treatment
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* Combination Product: Iodinated Contrast Agent (Omnipaque)
* Device: Dual Energy CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled to receive TAVR abdominal CT Exclusion Criteria: cannot undergo CT scan Allergy to intravenous contrast not controlled by steroids or benadryl GFR<30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml). | Combination Product: Iodinated Contrast Agent (Omnipaque)<br>* Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.<br>Device: Dual Energy CT<br>* Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.<br>|
| Experimental: Cohort 2<br>If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml. | Combination Product: Iodinated Contrast Agent (Omnipaque)<br>* Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.<br>Device: Dual Energy CT<br>* Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Quality of Images | 5-point Likert Scale | 18-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual energy CT