CT TAVR Abdomen Study (CT TAVR)

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Combination product: Iodinated Contrast Agent (Omnipaque); Device: Dual Energy CT

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vikas Kundra, M.D., Ph.D; Phone Number: 410-328-3477; Email: vkundra@som.umaryland.edu
• Study Contact Backup: Name: Nikita Rednam, B.S.; Phone Number: 410-706-5938; Email: nrednam@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
      • Contact: Vikas Kundra, MD PhD; Email: vkundra@som.umaryland.edu
      • Contact: Nikita Rednam; Phone Number: 8625961018; Email: nrednam@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Quality of Images	5-point Likert Scale	18-24 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Publications and helpful links

General Publications

• Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.
• Schoenhagen P, Hausleiter J, Achenbach S, Desai MY, Tuzcu EM. Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI). Cardiovasc Diagn Ther. 2011 Dec;1(1):44-56. doi: 10.3978/j.issn.2223-3652.2011.08.01.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dual energy CT
• Other Study ID Numbers: HP-00104800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No