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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
CT TAVR 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.Check my eligibility
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.See study design
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.
CT TAVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic Quality of Images
CT TAVR 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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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,492 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is low.I am scheduled for a CT scan before my heart valve replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do persons aged 85 and beyond have the option of participating in this trial?
"Subjects for this trial must be over 18 years old and below 88 to qualify."
Answered by AI
Has Cohort 1 received the necessary regulatory authorization from the Food and Drug Administration?
"According to our internal assessment, Cohort 1 has been granted a safety rating of 3 as it is currently on Phase 4. This denotes that the treatment has already received approval."
Answered by AI
Who are the participants this research requires?
"Eligibility for this medical research requires transcatheter aortic valve replacement and an age between 18 to 88 years old. Presently, 164 participants are being enrolled in the trial."
Answered by AI
Is there still room for participants in this clinical trial?
"The clinical trial website indicates that this study is no longer accepting enrollees. Initially posted on March 1st 2023 and revised February 24th 2023, patients are unable to participate in the program; however, 11 other trials remain open for registration at present."
Answered by AI
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