| NCT ID | NCT04645862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Bicuspid |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-12-31 |
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
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2020-12-01 with a primary completion date of 2027-12-31.
⚠ 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
The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age * Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment * Participant must sign the informed consent form Exclusion Criteria: * Pregnancy (determined by point of care urine pregnancy test) * Renal failure (estimated Glomerular Filtration Rate (eGFR) \< 30), precluding them from receiving intravenous contrast) * Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care) * Previous aortic valve replacement
Frequently Asked Questions
Who can join the NCT04645862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bicuspid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04645862 currently recruiting?
Yes, NCT04645862 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Pennsylvania to inquire about joining.
Where is the NCT04645862 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04645862 clinical trial?
NCT04645862 is sponsored by University of Pennsylvania. The trial plans to enroll 60 participants.