Recruiting

Stroke Prediction

Sponsor:

VPDiagnostics

Code:

NCT00860184

Conditions

Atherosclerotic Disease, Carotid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The purpose of this investigation is to determine the ability of the SmartRisk software module to predict stroke or stroke-related events due to carotid plaque within a high-risk population. The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid artery wall.

Conditions

Atherosclerotic Disease, Carotid

Study ID

NCT00860184

Start date

Nov, 2009

Status verified date

Apr, 2011

Completion date

Aug, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 50-79% stenosis of the carotid artery
  • age 18 or older
  • no ischemic neurovascular symptoms within preceding 6 months

Exclusion Criteria:

  • contraindication to MRI (e.g. weight > 130 kg, pregnancy)
  • prior or planned carotid endarterectomy or stenting
  • history of atrial fibrillation
  • prior neck irradiation

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

50-79% stenosis

Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older

Primary outcome measure

  • stroke or other cerebrovascular symptom (e.g. TIA) [ Time Frame: 18 month mean follow-up at 6 month intervals ]

Central Contacts and Locations

Locations

Carl T. Hayden Medical Research Foundation

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Raymond Q Migrino, MD

raymond.migrino@va.gov

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Prediman K Shah, MD

shahp@cshs.org

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

David Saloner, PhD

saloner@radiology.ucsf.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tatjana Rundek, MD

305-243-7847trundek@med.miami.edu

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Richard A Bernstein, MD

richard.bernstein4@gmail.com

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Kent Yucel, MD

kyucel@tuftsmedicalcenter.org

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Robert Greenman, PhD

rgreenma@caregroup.harvard.edu

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Kumar Rajamani, MD

krajaman@med.wayne.edu

Michigan State University

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

Kevin DeMarco, MD

J.DeMarco@radiology.msu.edu

Gotham Cardiovascular Research PC

Recruiting

New York, New York, United States, 10001

Contacts

Cezar S Stanilaoe, MD

Cezar.Stanilaoe@nyumc.org

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Thomas Riles, MD

Thomas.Riles@nyumc.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Joel Morrisett, PhD

morriset@bcm.tmc.edu

Principal Investigator:

Joel Morrisett, PhD

Western Institute for Biomedical Research

Recruiting

Salt Lake City, Utah, United States, 84158

Contacts

Gerald Treiman, MD

GSTREIMAN@EARTHLINK.NET

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Bob L Hou, PhD

304-293-1877bhou@hsc.wvu.edu

More Information

Sponsor

VPDiagnostics

Last update posted

Apr 14, 2011

Last verified

Apr, 2011

Keywords

  • carotid artery
  • atherosclerosis
  • stroke
  • transient ischemic attack
  • MRI
  • software
  • risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VPDiagnostics on 2011-04-14.