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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00543933
Eligibility Criteria:
Inclusion Criteria:
* Known pulmonary insufficiency status
* Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
* Clinically indicated cardiac magnetic resonance imaging study
Exclusion Criteria:
* Enrollment in another clinical trial
* Age less then 18 years
* Inability to provide informed consent
* Institutionalized individual
* Pregnant or lactating
* Serious claustrophobia
* Pacemaker/ICD
* Aneurysm clips
* Internal hardware
* Severe obesity (\>350lbs)
* Residual ventricular septal defect
* History of methemoglobinemia
* History of blood dyscrasias
* Acute pulmonary infection
* Pulmonary edema
* Hypersensitivity to nitric oxide or any of its components
* Left ventricle dysfunction (EF\<40%)
* Concurrent use of nitroglycerin or prilocaine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00543933
Study Brief:
Protocol Section:
NCT00543933