Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03337594
Eligibility Criteria:
Inclusion Criteria:
* Female or male pediatric patient (patients aged newborn to 18 years old at the time of the MRI scan).
* Patients who require cardiac surgery for clinical purposes and meet one of the following three criteria:
1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
3. Patients who have not been exposed to gadolinium-based contrast agent administration
Exclusion Criteria:
* Patient with abnormal renal function (defined as eGFR MDRD\<30 ml/min/1.73m2).
* Patient previously exposed to any other type of MRI gadolinium based contrast agent either at MUSC or at an outside facility
* Pregnant or breast feeding female patient
* Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to standard practice at MUSC).
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03337594
Study Brief:
Protocol Section:
NCT03337594