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CT TAVR Abdomen Study

NCT05758701 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758701 on ClinicalTrials.gov