CT TAVR Abdomen Study

Transcatheter Aortic Valve Replacement Clinical Trial

— CT TAVR  

Official title:

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758701
• Other study ID #: HP-00104800
• Status: Recruiting
• Phase: Phase 4
• Start date: September 19, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2023
• Source: University of Maryland, Baltimore
• Contact: Vikas Kundra, M.D., Ph.D
• Phone: 410-328-3477
• Email: vkundra[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Quality of Images	5-point Likert Scale	18-24 months