Evaluation of Vascular Pathology With 3D, Time-Resolved Phase Contrast Magnetic Resonance Imaging (MRI)

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00722904
Collaborator
(none)
40
1
39
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Vascular Pathology With 3D, Time-Resolved Phase Contrast MRI
    Study Start Date :
    Jun 1, 2007
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Sep 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients undergoing routine post-intervention surveillance of aortic coarctation

    2

    Healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. predicting late complications in patients status post coarctation repair so that preemptive intervention may be taken [For at least three years following the completion of the study, the database of patients will be updated for clinically relevant information]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 UCSF Medical Center San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Charles B Higgins, MD, UCSF Department of Radiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT00722904
    Other Study ID Numbers:
    • H627-30777
    • H627-30777-01A
    First Posted:
    Jul 28, 2008
    Last Update Posted:
    Oct 8, 2013
    Last Verified:
    Oct 1, 2013

    Study Results

    No Results Posted as of Oct 8, 2013