Evaluation of Vascular Pathology With 3D, Time-Resolved Phase Contrast Magnetic Resonance Imaging (MRI)
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Purpose
Aortic coarctation is a relatively common cardiovascular condition with high associated mortality if not treated. Even with successful repair, however, close follow up is needed as late complications can result in significant cardiovascular morbidity. MRI, with is ability to provide both anatomic and hemodynamic information, is becoming the imaging option of choice for post-intervention surveillance. Time-resolved, three-dimensional phase contrast magnetic resonance velocity (4D Flow) profiling enables the acquisition of multidirectional blood velocity data. The technique is well suited for evaluation of blood flow patterns in the thoracic aorta. By comparing aortic flow patterns in patients status post coarctation repair with those of healthy volunteers using 4D Flow, this study intends to characterize abnormal flow patterns in these patients with the eventual goal of better understanding and predicting late complications so that preemptive intervention may be taken.
Given the potential use of 4D Flow for evaluation of other types of vascular pathology in the aorta and other vascular regions, we hope to investigate the use of the technique on a limited basis for a broader population of adult patients. Other research groups have had success evaluating peripheral stenoses, as well as intracardiac and intracranial blood flow patterns with 4D Flow.
| Condition |
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Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Evaluation of Vascular Pathology With 3D, Time-Resolved Phase Contrast MRI |
- predicting late complications in patients status post coarctation repair so that preemptive intervention may be taken [ Time Frame: For at least three years following the completion of the study, the database of patients will be updated for clinically relevant information ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
patients undergoing routine post-intervention surveillance of aortic coarctation
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2
Healthy volunteers
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Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients: primarily status post intervention for repair of aortic coarctation and undergoing routine MRI follow up, but also adult patients with other vascular pathologies undergoing routine MRI evaluation, who may be good candidates for 4D Flow blood flow analysis.
Healthy subjects: healthy members of the radiology residency program and staff at UCSF.
Inclusion Criteria:
Patients: primarily status post intervention for repair of aortic coarctation and undergoing routine MRI follow up, but also adult patients with other vascular pathologies undergoing routine MRI evaluation, who may be good candidates for 4D Flow blood flow analysis.
Healthy subjects: healthy members of the radiology residency program and staff at UCSF.
Exclusion Criteria:
Anyone else.
Contacts and Locations| United States, California | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Charles B Higgins, MD | UCSF Department of Radiology |
More Information
Publications:
| Responsible Party: | Charles B. Higgins, MD, UCSF Department of Radiology |
| ClinicalTrials.gov Identifier: | NCT00722904 History of Changes |
| Other Study ID Numbers: | H627-30777, H627-30777-01A |
| Study First Received: | July 24, 2008 |
| Last Updated: | July 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
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post-intervention surveillance of aortic coarctation MRA and 2D phase contrast imaging 4D Flow velocity mapping Patients undergoing routine post-intervention surveillance of aortic coarctation Healthy volunteers |
ClinicalTrials.gov processed this record on June 17, 2013