Atherosclerotic Disease, CarotidSmartRiskNCT00860184
SmartRisk Stroke Prediction by MRI of Carotid Disease
An observational study of Atherosclerotic Disease, Carotid, run by VPDiagnostics at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Disease, Carotid
- How many people
- 300 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient referred for ultrasound assessment of carotid artery disease
Who may be able to join
- 50-79% stenosis of the carotid artery
- age 18 or older
- no ischemic neurovascular symptoms within preceding 6 months
Who cannot join
- contraindication to MRI (e.g. weight > 130 kg, pregnancy)
- prior or planned carotid endarterectomy or stenting
- history of atrial fibrillation
- prior neck irradiation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Kent Yucel, MD, kyucel@tuftsmedicalcenter.org
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Robert Greenman, PhD, rgreenma@caregroup.harvard.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Richard A Bernstein, MD, richard.bernstein4@gmail.com
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Kumar Rajamani, MD, krajaman@med.wayne.edu
- Recruiting
Michigan State University
East Lansing, Michigan, 48824
Kevin DeMarco, MD, J.DeMarco@radiology.msu.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Joel Morrisett, PhD, morriset@bcm.tmc.edu
Joel Morrisett, PhD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Prediman K Shah, MD, shahp@cshs.org
- Recruiting
University of Miami
Miami, Florida, 33136
Tatjana Rundek, MD, 305-243-7847, trundek@med.miami.edu
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Bob L Hou, PhD, 304-293-1877, bhou@hsc.wvu.edu
- Recruiting
Gotham Cardiovascular Research PC
New York, New York, 10001
Cezar S Stanilaoe, MD, Cezar.Stanilaoe@nyumc.org
- Recruiting
New York University School of Medicine
New York, New York, 10016
Thomas Riles, MD, Thomas.Riles@nyumc.edu
- Recruiting
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, 85012
Raymond Q Migrino, MD, raymond.migrino@va.gov
- Recruiting
Western Institute for Biomedical Research
Salt Lake City, Utah, 84158
Gerald Treiman, MD, GSTREIMAN@EARTHLINK.NET
- Recruiting
University of California San Francisco
San Francisco, California, 94143
David Saloner, PhD, saloner@radiology.ucsf.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98109
Xueqiao Zhao, MD, xueqiao@u.washington.edu
Xueqiao Zhao, MD
About this study
Official title: Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
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.
Read the detailed description
Carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (CEA) or stenting. Subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. However, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. Recently, VPDiagnostics developed a new module - SmartRisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. The SmartRisk module uses MRI data to compute a risk assessment from a specific atherosclerotic plaque. A continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. The purpose of this trial is to determine whether the SmartRisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.
- Conditions
- Atherosclerotic Disease, Carotid
- Keywords
- carotid artery, atherosclerosis, stroke, transient ischemic attack, MRI, software, risk
- Medical subject headings
- Carotid Artery Diseases, Atherosclerosis, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 50-79% stenosis | Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke or other cerebrovascular symptom (e.g. TIA)
Measured: 18 month mean follow-up at 6 month intervals
Secondary outcomes (1)
any cardiovascular event (e.g. MI)
Measured: 18 month mean follow-up at 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Disease, CarotidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VPDiagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- William S Kerwin, PhD, Principal investigator, VPDiagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860184
- Sponsor's protocol ID
- VPD2008A
- Other IDs
- 5R44HL070576-05
- Acronym
- SmartRisk
- Status last verified
- Apr 2011
- First submitted
- 11 Mar 2009
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT00860184
- Acronym / sponsor ID
- SmartRisk / VPD2008A
- Conditions
- Atherosclerotic Disease, Carotid
- Keywords
- carotid artery, atherosclerosis, stroke, transient ischemic attack, MRI, software, risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- VPDiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (CEA) or stenting. Subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. However, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. Recently, VPDiagnostics developed a new module - SmartRisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. The SmartRisk module uses MRI data to compute a risk assessment from a specific atherosclerotic plaque. A continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. The purpose of this trial is to determine whether the SmartRisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50-79% stenosis | – | –Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient referred for ultrasound assessment of carotid artery disease
Key inclusion criteria (3 listed)
- 50-79% stenosis of the carotid artery
- age 18 or older
- no ischemic neurovascular symptoms within preceding 6 months
Key exclusion criteria (4 listed)
- contraindication to MRI (e.g. weight > 130 kg, pregnancy)
- prior or planned carotid endarterectomy or stenting
- history of atrial fibrillation
- prior neck irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stroke or other cerebrovascular symptom (e.g. TIA)
Time frame: 18 month mean follow-up at 6 month intervals
1 secondary outcome
any cardiovascular event (e.g. MI)
Time frame: 18 month mean follow-up at 6 month intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
- VPDiagnostics websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William S Kerwin, PhD principal investigator
VPDiagnostics
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Disease, Carotid, run by VPDiagnostics at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke or other cerebrovascular symptom (e.g. TIA) (time frame: 18 month mean follow-up at 6 month intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.