Status:
ACTIVE_NOT_RECRUITING
Symptomatic Carotid Outcomes Registry
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Carotid Stenosis
Ischemic Stroke
Eligibility:
All Genders
40+ years
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 (NAS...
Detailed Description
This study will only be evaluating clinical care and no interventions will be done specifically for this research. * Informed consent from patient or legally authorized representative. * Participant ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- \-
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05300737
Start Date
August 1 2022
End Date
December 1 2026
Last Update
October 17 2025
Active Locations (18)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
Rush Medical Center
Chicago, Illinois, United States, 60612