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NCT Number: NCT05758701

CT TAVR Abdomen Study

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.

Recruiting

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Key information

Conditions

Transcatheter Aortic Valve Replacement

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodinated Contrast Agent (Omnipaque)

Combination Product

Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.

Dual Energy CT

Device

Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Primary outcomes

  1. Diagnostic Quality of Images

    Time frame: 18-24 months

    5-point Likert Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Rosy Njonkou, M.S.

CONTACT

[email protected]

410-706-0943

Vikas Kundra, M.D., Ph.D

CONTACT

[email protected]

410-328-3477

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

Acronym: CT TAVR

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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