Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI).
Paul Schoenhagen, Jörg Hausleiter, Stephan Achenbach...
https://pubmed.ncbi.nlm.nih.gov/24282684/Actively Recruiting
Led by University of Maryland, Baltimore · Updated on 2026-07-01
164
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are exploring whether lowering the dose of iodinated intravenous contrast in CT scans can be effective for presurgical planning of transcatheter aortic valve replacement TAVR. This study addresses the challenge of global shortages of iodine-based contrast and aims to find ways to reduce contrast use while maintaining image quality. The potential benefits include cost savings for hospitals and a reduced risk of acute kidney injury, especially for patients with impaired kidney function. Participants will undergo CT imaging using dual energy CT scanners that allow monoenergetic image reconstruction, enhancing iodine contrast in images. The study involves two cohorts one receiving a reduced contrast dose of one-third the standard amount 33 ml, and if those images are satisfactory, a second cohort receiving one-fourth the standard dose 25 ml. If images with the lower dose are not satisfactory, the dose may be increased to 50 ml. During the study, participants will have their imaging assessed for diagnostic quality over an 18 to 24 month period. The study includes monitoring of image quality and safety, with the primary outcome focusing on the diagnostic quality of CT images. Participants will be followed through the imaging process, with no masking or randomization involved, and the entire study is planned to complete by March 2028.
CONDITIONS
CT TAVR Abdomen Study
V
Vikas Kundra, M.D., Ph.D
R
Rosy Njonkou, M.S.
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University of Maryland, Baltimore
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Reduced‑dose dual‑energy CT | Standard CT pathway |
|---|---|---|
| What the imaging approach is | CT using reduced-volume iodinated contrast and dual‑energy imaging reconstruction for abdominal assessment before TAVR | Traditional diagnostic CT pathway using full recommended iodinated contrast volume for pre‑TAVR planning |
| Primary clinical purpose | Provide diagnostic abdominal imaging for procedural planning with lower contrast load | Obtain full diagnostic detail for access and annular assessment during TAVR planning using standard contrast |
| How the imaging is performed | Single CT scan using lower-vol‑ume Omnipaque contrast with dual‑energy CT reconstruction | Conventional single‑phase contrast-enhanced CT using full standard contrast dose |
| Evidence on diagnostic image quality | Diagnostic quality maintained with reduced contrast via low‑dose or dual‑energy CT approaches | Proven standard protocol provides reliable diagnostic detail for valve and access evaluation |
| Important limitations | May require access to dual‑energy CT scanners and expertise; generalizability may be limited | Higher contrast volume may pose risk in patients with reduced renal function |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 to 24 months
Participants receive a reduced dose of iodinated contrast during CT imaging using dual energy CT scanners. The first cohort receives one-third the standard dose, and if images are satisfactory, a second cohort receives one-fourth the dose. Dose adjustments may be made based on image quality.
Imaging visits as scheduled
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Paul Schoenhagen, Jörg Hausleiter, Stephan Achenbach...
https://pubmed.ncbi.nlm.nih.gov/24282684/Hitinder S Gurm, Simon R Dixon, Dean E Smith...
https://pubmed.ncbi.nlm.nih.gov/21851878/University of Maryland, Baltimore
Lead Sponsor