Symptomatic Carotid Outcomes Registry
SCORE
1 other identifier
observational
114
2 countries
18
Brief Summary
The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be \<5%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Longer than P75 for all trials
18 active sites
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 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
October 20, 2025
October 1, 2025
4.3 years
March 9, 2022
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ischemic stroke
ipsilateral to carotid stenosis, with radiologic confirmation
within 12 months
Secondary Outcomes (1)
Myocardial infarction
within 12 months
Study Arms (1)
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
Interventions
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
Eligibility Criteria
Patients with 50-99% symptomatic carotid stenosis and low risk clinical or radiologic features
You may qualify if:
- Age ≥40 years plus stroke or TIA ipsilateral to 50-99% ICA stenosis
- In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk
- Clinical Reduced Stroke RISK:
- Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
- Female sex
- Most recent stroke or TIA \>1 week ago
- Radiologic Reduced Stroke RISK:
- Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
- Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
- For patients with TIA: brain MRI shows no DWI lesion
You may not qualify if:
- Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration \<6 minutes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hartford Hospital
Hartford, Connecticut, 06102, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush Medical Center
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
University of Rochester
Rochester, New York, 14642, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Baylor Medicine
Houston, Texas, 77030, 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, H2X 0C1, Canada
Related Publications (4)
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.
PMID: 19850894RESULTChaturvedi 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.
PMID: 30588374RESULTSaba 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.
PMID: 30954372RESULTRothwell 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.
PMID: 15043958RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seemant Chaturvedi, MD
School of Medicine, University of Maryland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 29, 2022
Study Start
August 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share