NCT00860184

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

2.8 years

First QC Date

March 11, 2009

Last Update Submit

April 13, 2011

Conditions

Atherosclerotic Disease, Carotid

Keywords

carotid arteryatherosclerosisstroketransient ischemic attackMRIsoftwarerisk

Outcome Measures

Primary Outcomes (1)

  • stroke or other cerebrovascular symptom (e.g. TIA)

    18 month mean follow-up at 6 month intervals

Secondary Outcomes (1)

  • any cardiovascular event (e.g. MI)

    18 month mean follow-up at 6 month intervals

Study Arms (1)

50-79% stenosis

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient referred for ultrasound assessment of carotid artery disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Carl T. Hayden Medical Research Foundation

Phoenix, Arizona, 85012, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

Gotham Cardiovascular Research PC

New York, New York, 10001, United States

RECRUITING

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Western Institute for Biomedical Research

Salt Lake City, Utah, 84158, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

NOT YET RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carotid Artery DiseasesAtherosclerosisStrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesBrain Ischemia

Study Officials

  • William S Kerwin, PhD

    VPDiagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

US(15)