Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Recruitment status was Recruiting
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Purpose
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease.
The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor.
Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.
| Condition |
|---|
|
Fontan Procedure. Hypoplastic Left Heart Syndrome Tricuspid Atresia Double Inlet Left Ventricle. |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Single right ventricles |
| Single left ventricles |
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study subjects: Patients with univentricular hearts who have undergone a Fontan procedure will be recruited for participation in the study.
Inclusion Criteria:
- Anatomy: The investigators will enroll 10 patients with single right ventricles status post Fontan and 10 patients with single left ventricles status post Fontan.
- Age range: 5 patients in each group will be between the ages of 10-18 years of age and 5 patients in each group will be older than 18 years of age.
Exclusion Criteria:
- Study subjects will be excluded if there are any contraindications to MRI including permanent pacemaker, ICD, retained permanent wires, cerebral aneurysm clips, neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone growth/fusion stimulators, or cochlear implants.
- In addition, patients with implanted hardware that may lead to inadequate imaging, such as steel coils or ventricular septal defect occluder devices, will be excluded.
- Finally, patients with developmental delay or physical limitations precluding cooperation with the MRI or exercise test or patients with claustrophobia will be excluded. Patients will be asked if there is any chance that they are pregnant. If they are possibly pregnant, they will be excluded.
Contacts and Locations| United States, California | |
| University of California, San-Francisco | Recruiting |
| San-Francisco, California, United States, 94143 | |
| Contact: Alison Meadows, MD, PhD 415-353-2756 Alison.meadows@ucsf.edu | |
| Contact: Alexander Lowenthal, MD 415 476 1802 Alexander.lowenthal@ucsf.edu | |
| Principal Investigator: | Alexander Lowenthal, MD | University of California, San Francisco |
| Study Chair: | Alison Meadows, MD, PhD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | Alison Meadows, MD, PhD, University of California San Francisco |
| ClinicalTrials.gov Identifier: | NCT01107990 History of Changes |
| Other Study ID Numbers: | H64391-34645-01 |
| Study First Received: | April 20, 2010 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hypoplastic Left Heart Syndrome Tricuspid Atresia Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities Heart Valve Diseases |
ClinicalTrials.gov processed this record on May 21, 2013