Expired Study
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San Francisco, California 94143


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00722826


Primary Contact:

Principal Investigator
Charles B Higgins, MD
UCSF Department of Radiology

Karen G Ordovas, MD
Phone: 415-476-4375
Email: karen.ordovas@radiology.ucsf.edu


Backup Contact:

Email: laura.moore@radiology.ucsf.edu
Laura J Moore, MA
Phone: 415-476-1397


Location Contact:

San Francisco, California 94143
United States

Karen G Ordovas, MD
Phone: 415-476-4375

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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