CT TAVR Abdomen Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iodinated Contrast Agent (Omnipaque), Dual Energy CT.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement. Basic parameters: 18 years — 88 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR
Overview
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.
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.
Primary outcome measures
- Diagnostic Quality of Images [Time frame: 18-24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Maryland Medical Center — Baltimore
Publications
- 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. PMID 24282684
- 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. PMID 21851878
Identifiers
NCT: NCT05758701 · HP-00104800