Tetralogy of Fallot Seed Grant - Full Text View

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional

Official Title:	MRI Assessment of Right Ventricular Function in Patients After Repair of Tetralogy of Fallot

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.

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
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
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

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:

Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol. 2004 Mar 17;43(6):1068-74.

Davlouros PA, Kilner PJ, Hornung TS, Li W, Francis JM, Moon JC, Smith GC, Tat T, Pennell DJ, Gatzoulis MA. Right ventricular function in adults with repaired tetralogy of Fallot assessed with cardiovascular magnetic resonance imaging: detrimental role of right ventricular outflow aneurysms or akinesia and adverse right-to-left ventricular interaction. J Am Coll Cardiol. 2002 Dec 4;40(11):2044-52.

Helbing WA, de Roos A. Clinical applications of cardiac magnetic resonance imaging after repair of tetralogy of Fallot. Pediatr Cardiol. 2000 Jan-Feb;21(1):70-9. Review.

Higgins CB, Caputo GR. Role of MR imaging in acquired and congenital cardiovascular disease. AJR Am J Roentgenol. 1993 Jul;161(1):13-22. Review.

van der Geest RJ, Reiber JH. Quantification in cardiac MRI. J Magn Reson Imaging. 1999 Nov;10(5):602-8. Review.

Higgins CB, Sakuma H. Heart disease: functional evaluation with MR imaging. Radiology. 1996 May;199(2):307-15. Review.

Pettigrew RI, Oshinski JN, Chatzimavroudis G, Dixon WT. MRI techniques for cardiovascular imaging. J Magn Reson Imaging. 1999 Nov;10(5):590-601. Review.

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

Keywords provided by University of California, San Francisco:

Pulmonary Regurgitation

Tetralogy of Fallot

Study placed in the following topic categories:

Pulmonary Valve Insufficiency

Heart Diseases

Cardiovascular Abnormalities

Tetralogy of Fallot

Fallot tetralogy

Congenital Abnormalities

Heart Defects, Congenital

Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00722826