CT TAVR Abdomen Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05758701
Phase
PHASE4
Status
Recruiting
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Conditions

  • Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 19, 2023
Status verified
Apr 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Diagnostic Quality of Images [ Time Frame: 18-24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Vikas Kundra, MD PhD
[email protected]
Rosy Njonkou
[email protected]
410-706-0943

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