ClinicalTrials.Veeva

Menu

CT TAVR Abdomen Study

University of Maryland Baltimore (UMB) logo

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)

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

Trial contacts and locations

1

Loading...

Central trial contact

Rosy Njonkou, M.S.; Vikas Kundra, M.D., Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems