Pulmonary Regurgitation After Repair of Tetralogy of FallotNCT00722826
Tetralogy of Fallot Seed Grant
An observational study of Pulmonary Regurgitation After Repair of Tetralogy of Fallot, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pulmonary Regurgitation After Repair of Tetralogy of Fallot
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Contraindication for MRI study. Claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94143
About this study
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.
- Keywords
- Pulmonary Regurgitation, Tetralogy of Fallot
- Medical subject headings
- Pulmonary Valve Insufficiency, Tetralogy of Fallot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Regurgitation After Repair of Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles B Higgins, MD, Principal investigator, UCSF Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722826
- Sponsor's protocol ID
- H627-29142-02
- Other IDs
- UCSF Seed Grant FWA #00000068
- Status last verified
- May 2015
- First submitted
- 23 Jul 2008
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15028368Davlouros 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.
PubMed 12475468Helbing 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.
PubMed 10672616Araoz 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.
PubMed 8517291van 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.
PubMed 10548768Higgins CB, Sakuma H. Heart disease: functional evaluation with MR imaging. Radiology. 1996 May;199(2):307-15. doi: 10.1148/radiology.199.2.8668769.
PubMed 8668769Pettigrew 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.
PubMed 10548767
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Assessment of Right Ventricular Function in Patients After Repair of Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT00722826
- Acronym / sponsor ID
- H627-29142-02
- Keywords
- Pulmonary Regurgitation, Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Contraindication for MRI study. Claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Background: PubMed 15028368Geva 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.
- Background: PubMed 12475468Davlouros 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.
- Background: PubMed 10672616Helbing 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.
- BackgroundAraoz 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.
- Background: PubMed 8517291Higgins 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.
- Background: PubMed 10548768van 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.
- Background: PubMed 8668769Higgins CB, Sakuma H. Heart disease: functional evaluation with MR imaging. Radiology. 1996 May;199(2):307-15. doi: 10.1148/radiology.199.2.8668769.
- Background: PubMed 10548767Pettigrew 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles B Higgins, MD principal investigator
UCSF Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Regurgitation After Repair of Tetralogy of Fallot, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00722826, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.