Pulmonary Regurgitation After Repair of Tetralogy of Fallot Clinical Trial
Official title:
MRI Assessment of Right Ventricular Function in Patients After Repair of Tetralogy of Fallot
Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old
will be recruited from the UCSF adult congenital heart disease clinic. Since there is no
data in the literature describing the prevalence of abnormal MRI volumetric and functional
parameters in asymptomatic patients with PR after ToF repair, a pilot study with 30 patients
will be conducted. Increase in sample size may be necessary in the future to accurately
interpret the data. After informed consent is obtained, clinical history and physical
examination as well as review of old charts will be performed to characterize these
patient's clinical status. All patients will undertake a graduated supine bicycle exercise
test with MVO2 measurement to assess exercise capacity.
MRI studies will be performed in a 1.5 tesla unit. SSFP cine images will be obtained in the
short-axis plane encompassing the entire heart. Velocity-encoded cine MR images will be
obtained perpendicular to the direction of blood flow in the main pulmonary artery.
Volumetric and flow analysis will be performed in a separate dedicated workstation by a
radiologist. End-diastolic volume, end-systolic volume, ejection fraction, total ejection
fraction and pulmonary regurgitant fraction will be calculated.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years and older |
| Eligibility |
Inclusion Criteria: Patients over 13 years of age with pulmonary regurgitation after surgical correction of tetralogy of Fallot. 1. Adult patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the adult congenital heart disease clinic at UCSF or 2. Pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the pediatric congenital heart disease clinic at UCSF and are referred for a clinically indicated cardiac MRI studies or 3. Adult and pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are referred for clinically indicated MRI studies at UCSF. Exclusion Criteria: Contraindication for MRI study. Claustrophobia. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| United States | UCSF Medical Center | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Francisco |
United States,
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