CT TAVR Abdomen Study

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 4

Conditions: Transcatheter Aortic Valve Replacement

Treatments: Device: Dual Energy CT; Combination Product: Iodinated Contrast Agent (Omnipaque)

Study type: Interventional

Funder types: Other

Identifiers

NCT05758701

HP-00104800

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Cohort 1

Experimental group

Description:

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

Treatment:

Combination Product: Iodinated Contrast Agent (Omnipaque)

Device: Dual Energy CT

Cohort 2

Experimental group

Description:

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.

Treatment:

Combination Product: Iodinated Contrast Agent (Omnipaque)

Device: Dual Energy CT