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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01192360
Eligibility Criteria:
Inclusion Criteria:
Cardiac Patients:
1. Patients \> 6 years of age
2. Patients with suspected or confirmed congenital or acquired heart disease
3. Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
4. And receive gadolinium (= MRI contrast medium) as part of their clinical investigation
Pulmonary Patients:
1. Patients \> 6 years of age
2. Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.
Exclusion Criteria:
1. Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
2. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
3. Patients with a known allergy to gadolinium.
4. Patients with a history of allergic disposition or have anaphylactic reactions
5. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min)
6. Have Sickle Cell anemia
7. Known pregnancy, or breast feeding
8. Patient is uncooperative during a MRI without sedation or anesthesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01192360
Study Brief:
Protocol Section:
NCT01192360