CT TAVR Abdomen Study

Phase 4

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement
• Interventions: Combination Product: Iodinated Contrast Agent (Omnipaque); Device: Dual Energy CT

• Registration Number: NCT05758701
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Study Start: 2023-09-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• scheduled to receive TAVR abdominal CT

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Exclusion Criteria

• cannot undergo CT scan
• Allergy to intravenous contrast not controlled by steroids or benadryl
• GFR<30

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Dual Energy CT	A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).
Cohort 1	Iodinated Contrast Agent (Omnipaque)	A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).
Cohort 2	Dual Energy CT	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.
Cohort 2	Iodinated Contrast Agent (Omnipaque)	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 Measures

Name	Time	Method
Diagnostic Quality of Images	18-24 months	5-point Likert Scale

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States