Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
114 participants
OBSERVATIONAL
2022-08-01
2026-12-31
Brief Summary
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Detailed Description
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* Informed consent from patient or legally authorized representative.
* Participant survey/questionnaire completion at baseline, 6 and 12 months after enrollment
* All data collected will be entered into a secure research data registry created for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic carotid stenosis with low risk features
50-99% symptomatic carotid stenosis with low clinical or radiologic risk features (see inclusion criteria) Patients will receive intensive medical therapy, including dual antiplatelet therapy, high potency statins, BP control, and lifestyle modification
intensive medical therapy
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
Interventions
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intensive medical therapy
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
Eligibility Criteria
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Inclusion Criteria
In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk
Clinical Reduced Stroke RISK:
1. Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
2. Female sex
3. Most recent stroke or TIA \>1 week ago
Radiologic Reduced Stroke RISK:
1. Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
2. Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
3. For patients with TIA: brain MRI shows no DWI lesion
Exclusion Criteria
Alcohol and substance abuse within the prior 24 months
Clinically significant bleeding diathesis (platelet count \<100K, prothrombin time \>14 seconds)
Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)
Left ventricular ejection fraction \<20%
Known allergy or intolerance to aspirin or clopidogrel
Life expectancy less than 12 months
Moderate/severe dementia (Mini-mental or MOCA score \<22
Modified Rankin score of \>4
Nonatherosclerotic cause of carotid stenosis
Most recent symptomatic event \>180 days from the time of enrollment
\-
40 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Seemant Chaturvedi
Professor of Neurology
Principal Investigators
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Seemant Chaturvedi, MD
Role: PRINCIPAL_INVESTIGATOR
School of Medicine, University of Maryland
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
University of Rochester
Rochester, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Baylor Medicine
Houston, Texas, United States
Calgary Health Sciences Center
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, MN, Canada
Northern Ontario School of Medicine
Greater Sudbury, Ontario, Canada
Western University/London Health Sciences Center
London, Ontario, Canada
CHUM
Montreal, Quebec, Canada
Countries
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References
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King A, Markus HS. Doppler embolic signals in cerebrovascular disease and prediction of stroke risk: a systematic review and meta-analysis. Stroke. 2009 Dec;40(12):3711-7. doi: 10.1161/STROKEAHA.109.563056. Epub 2009 Oct 22.
Chaturvedi S. Treatment of a hot carotid: More fuel is needed to clarify the best treatments. Neurol Clin Pract. 2018 Dec;8(6):466-467. doi: 10.1212/CPJ.0000000000000561. No abstract available.
Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.
Other Identifiers
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00088344-2
Identifier Type: -
Identifier Source: org_study_id
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