| NCT ID | NCT05758701 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Transcatheter Aortic Valve Replacement |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 164 participants in total. It began in 2023-09-19 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05758701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying Transcatheter Aortic Valve Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05758701 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05758701 currently recruiting?
Yes, NCT05758701 is actively recruiting participants. Contact the research team at vkundra@som.umaryland.edu for enrollment information.
Where is the NCT05758701 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05758701 clinical trial?
NCT05758701 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 164 participants.