CT TAVR Abdomen Study

NCT ID: NCT05758701

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort 1

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

Group Type EXPERIMENTAL

Iodinated Contrast Agent (Omnipaque)

Intervention Type COMBINATION_PRODUCT

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

Dual Energy CT

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Iodinated Contrast Agent (Omnipaque)

Intervention Type COMBINATION_PRODUCT

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

Dual Energy CT

Intervention Type DEVICE

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

Interventions

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Iodinated Contrast Agent (Omnipaque)

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

Intervention Type COMBINATION_PRODUCT

Dual Energy CT

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Vikas Kundra

Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vikas Kundra, M.D., Ph.D

Role: CONTACT

410-328-3477

Rosy Njonkou, M.S.

Role: CONTACT

410-706-0943

Facility Contacts

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Vikas Kundra, MD PhD

Role: primary

Rosy Njonkou

Role: backup

410-706-0943

References

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Lai MZ, Duzgunes N, Szoka FC. Effects of replacement of the hydroxyl group of cholesterol and tocopherol on the thermotropic behavior of phospholipid membranes. Biochemistry. 1985 Mar 26;24(7):1646-53. doi: 10.1021/bi00328a012.

Reference Type BACKGROUND
PMID: 3839132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21851878 (View on PubMed)

Other Identifiers

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HP-00104800

Identifier Type: -

Identifier Source: org_study_id

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