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Tetralogy of Fallot Seed Grant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, San Francisco.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00722826
First received: July 23, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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.


Condition
Pulmonary Regurgitation After Repair of Tetralogy of Fallot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: MRI Assessment of Right Ventricular Function in Patients After Repair of Tetralogy of Fallot

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a cross sectional study. Patients with pulmonary regurgitation after repair of tetralogy of Fallot assisted in the adult or pediatric congenital heart disease clinic or referred for clinical MRI studies at our institution will be invited to participate in the study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722826

Contacts
Contact: Karen G Ordovas, MD 415-476-4375 karen.ordovas@radiology.ucsf.edu
Contact: Laura J Moore, MA 415-476-1397 laura.moore@radiology.ucsf.edu

Locations
United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Karen G Ordovas, MD    415-476-4375      
Sub-Investigator: Karen G Ordovas, MD         
Sub-Investigator: Elyse Foster, MD         
Sub-Investigator: Katy Lease, MD         
Sub-Investigator: Jeremy Collins, MD         
Sub-Investigator: Alison K Meadows, MD         
Sub-Investigator: Valerie Bosco, RN         
Sub-Investigator: Maythem Saeed, DVM, PhD         
Sub-Investigator: Maureen Kohi, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Charles B Higgins, MD UCSF Department of Radiology
  More Information

Publications:
Araoz PA, Reddy GP, Higgins CB. Congenital heart disease. In: Higgins CB, de Roos A, eds. Cardiovascular MRI and MRA. 1 ed. Philadelphia: Lippincott Williams & Wilkins, 2003; 122-135.

Responsible Party: Charles B. Higgins, MD, UCSF Department of Radiology
ClinicalTrials.gov Identifier: NCT00722826     History of Changes
Other Study ID Numbers: H627-29142-02, UCSF Seed Grant FWA #00000068
Study First Received: July 23, 2008
Last Updated: July 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pulmonary Regurgitation
Tetralogy of Fallot

Additional relevant MeSH terms:
Pulmonary Valve Insufficiency
Tetralogy of Fallot
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 25, 2014