- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00722826
Tetralogy of Fallot Seed Grant
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- UCSF Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Collaborators and Investigators
Investigators
- Principal Investigator: Charles B Higgins, MD, UCSF Department of Radiology
Publications and helpful links
General 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. doi: 10.1016/j.jacc.2003.10.045.
- 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. doi: 10.1016/s0735-1097(02)02566-4.
- 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. doi: 10.1007/s002469910009.
- 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.
- Higgins CB, Caputo GR. Role of MR imaging in acquired and congenital cardiovascular disease. AJR Am J Roentgenol. 1993 Jul;161(1):13-22. doi: 10.2214/ajr.161.1.8517291.
- van der Geest RJ, Reiber JH. Quantification in cardiac MRI. J Magn Reson Imaging. 1999 Nov;10(5):602-8. doi: 10.1002/(sici)1522-2586(199911)10:53.0.co;2-c.
- Higgins CB, Sakuma H. Heart disease: functional evaluation with MR imaging. Radiology. 1996 May;199(2):307-15. doi: 10.1148/radiology.199.2.8668769.
- Pettigrew RI, Oshinski JN, Chatzimavroudis G, Dixon WT. MRI techniques for cardiovascular imaging. J Magn Reson Imaging. 1999 Nov;10(5):590-601. doi: 10.1002/(sici)1522-2586(199911)10:53.0.co;2-s.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H627-29142-02
- UCSF Seed Grant FWA #00000068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Regurgitation After Repair of Tetralogy of Fallot
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Medtronic CardiovascularRecruitingCongenital Heart Disease | Pulmonary Regurgitation | Tetrology of Fallot | RVOT AnomalyUnited States
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Medtronic Heart ValvesActive, not recruitingCongenital Heart Disease | Pulmonary Regurgitation | Tetrology of Fallot | RVOT AnomalyUnited States, Canada, Japan
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Paris Cardiovascular Research Center (Inserm U970)European Georges Pompidou Hospital; Centre Chirurgical Marie Lannelongue; Hôpital... and other collaboratorsRecruitingCongenital Heart Disease | Ventricular Arrythmia | Pulmonary Valve Regurgitation | Fallot TetralogyFrance
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Rigshospitalet, DenmarkOdense University Hospital; Aarhus University HospitalRecruitingTetralogy of Fallot | Pulmonary RegurgitationDenmark
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Shanghai Zhongshan HospitalShanghai Children's Medical Center; Shanghai Chest Hospital; Fu Wai Hospital,... and other collaboratorsUnknownTetralogy of Fallot | Pulmonary RegurgitationChina
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Assistance Publique Hopitaux De MarseilleCompletedTetralogy of Fallot With Pulmonary StenosisFrance
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Shanghai Jiao Tong University School of MedicineCompletedCongenital Heart Defects | Tetralogy Of FallotChina
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Johns Hopkins UniversityMedtronicCompletedTetralogy of Fallot | Pulmonary Regurgitation | Pulmonary StenosisUnited States
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Aditya KazaNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingComplete Atrioventricular Canal | Ventricular Septal Defect | Tetralogy of Fallot With Pulmonary StenosisUnited States
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Meshalkin Research Institute of Pathology of CirculationCompletedPulmonary Atresia With Ventricular Septal Defect | Tetralogy of Fallot With Pulmonary AtresiaRussian Federation