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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00722904
First received: July 24, 2008
Last updated: October 4, 2013
Last verified: October 2013
  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
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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
Study Completion Date: September 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients undergoing routine post-intervention surveillance of aortic coarctation
2
Healthy volunteers

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722904

Locations
United States, California
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
  More Information

Publications:
Hope MD, Levin JM, Markl M, Draney MT, Wilson N, Herfkens RJ. 4D Magnetic Resonance Velocity Mapping: Velocity Profile of Blood-Flow Through the Thoracic Aorta in 10 Healthy Volunteers. Abstract. ISMRM 12th Scientific Meeting, 2004
Hope MD, Levin JM, Markl M, Draney MT, Alley MT, Dunn WN, Pelc NJ, Herfkens RJ. Four-Dimensional Magnetic Resonance Velocity Mapping: Velocity Profile of Blood Flow Through the Thoracic Aorta in 10 Healthy Volunteers. Lauterbur Award. Young Investigator Research Abstract Awards, SCBT/MR, 2004.
Frydrychowicz A, Winterer JT, Zaitsev M, Jung B, Hennig J, Langer M, Markl M. Visualization of iliac and proximal femoral artery hemodynamics using time-resolved 3D phase contrast MRI at 3T. jMRI 2007 vol. 25 pp. 1085-92. 15. Bammer R, Hope TA, Aksoy M, Alley MT. Time-resolved 3D quantitative flow MRI of the major intracranial vessels: initial experience and comparative evaluation at 1.5T and 3.0T in combination with parallel imaging. MRM 2007: 57:127-40.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00722904     History of Changes
Other Study ID Numbers: H627-30777, H627-30777-01A
Study First Received: July 24, 2008
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
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 July 24, 2014