University of Maryland, Baltimore

CT TAVR Abdomen Study

Purpose

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.

Condition

Transcatheter Aortic Valve Replacement

Eligibility

Eligible Ages: Between 18 Years and 88 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1	A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).	Combination Product: Iodinated Contrast Agent (Omnipaque) Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage. Device: Dual Energy CT Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.
Experimental Cohort 2	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) Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage. Device: Dual Energy CT Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201

Contact:
Vikas Kundra, MD PhD
vkundra@som.umaryland.edu

More Details

Status: Recruiting
Sponsor: University of Maryland, Baltimore

Study Contact

Vikas Kundra, M.D., Ph.D
410-328-3477
vkundra@som.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.