Symptomatic Carotid Outcomes Registry

Study Overview
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Brief Summary
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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%.

Detailed Description
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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 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.

Official Title
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Symptomatic Carotid Outcomes Registry With Multi-center Evaluation

Conditions
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Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Other: intensive medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 >2 weeks 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 Criteria: Atrial fibrillation or other high-risk sources of cardiac embolism 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 -

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic carotid stenosis with low risk features<br>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 | Other: intensive medical therapy<br>* Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke | ipsilateral to carotid stenosis, with radiologic confirmation | within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements | within 12 months |