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:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT02004756
Eligibility Criteria:
Inclusion Criteria:
Fontan Patients:
1. Patients who have had the Fontan cardiac procedure
2. 10-16 years of age
3. Written Informed Consent
Healthy Controls:
1. 10 - 16 years of age
2. Written Informed Consent
Exclusion Criteria:
Fontan Patients:
1. Contraindication to exercise
2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
4. Patients with a known allergy to gadolinium.
5. Patients with a history of allergic disposition or have anaphylactic reactions
6. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min)
7. Have Sickle Cell anemia
8. Known pregnancy, or breast feeding
9. Patient is uncooperative during a MRI without sedation or anesthesia
Healthy Controls:
1. Contraindication to exercise
2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
4. Patient is uncooperative during a MRI without sedation or anesthesia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT02004756
Study Brief:
Protocol Section:
NCT02004756