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Low-Dose Contrast CT for TAVR Planning (CT TAVR Trial)

Phase 4

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying if lower doses of contrast agent during CT scans can reduce kidney injury risk & supply shortage. It's also examining if low doses can be used for presurgical planning of TAVR procedures.

Who is the study for?

This trial is for patients scheduled to undergo a CT scan of the abdomen as part of planning for their transcatheter aortic valve replacement (TAVR) procedure. Participants must be able to have a CT scan and not have severely reduced kidney function (GFR<30) or an uncontrolled allergy to IV contrast, even with steroids or Benadryl.

What is being tested?

The study is testing if using a lower dose of iodinated contrast agent (Omnipaque) during dual-energy CT scans can still provide clear images for TAVR surgery planning. This could help conserve contrast material, reduce costs, and potentially decrease the risk of kidney injury in vulnerable patients.

What are the potential side effects?

Possible side effects may include allergic reactions to the Omnipaque contrast agent such as rash, itching, or more severe responses that are usually controllable with medications like steroids or Benadryl. There's also a potential risk of acute kidney injury from the contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic Quality of Images

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

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 II: Cohort 1Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dual Energy CT

2014

N/A

~100

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