SCORE: Symptomatic Carotid Outcomes Registry
Study Details
Study Description
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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study will only be evaluating clinical care and no interventions will be done specifically for this research.
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Informed consent from patient or legally authorized representative.
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Participant survey/questionnaire completion at baseline, 6 and 12 months after enrollment
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All data collected will be entered into a secure research data registry created for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: intensive medical therapy
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
|
Outcome Measures
Primary Outcome Measures
- Ischemic stroke [within 12 months]
ipsilateral to carotid stenosis, with radiologic confirmation
Secondary Outcome Measures
- Myocardial infarction [within 12 months]
ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements
Eligibility Criteria
Criteria
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:
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Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
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Female sex
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Most recent stroke or TIA >2 weeks ago
Radiologic Reduced Stroke RISK:
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Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
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Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
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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 >3
Nonatherosclerotic cause of carotid stenosis
Most recent symptomatic event >180 days from the time of enrollment
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Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Maryland, Baltimore
Investigators
- Principal Investigator: Seemant Chaturvedi, MD, School of Medicine, University of Maryland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00088344-2