NCT05758701

CT TAVR Abdomen Study

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-09-19
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-03-07
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study