Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack
Conditions
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%.
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 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.
Interventions
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
Sponsors
University of Maryland, Baltimore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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: 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
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke | within 12 months | ipsilateral to carotid stenosis, with radiologic confirmation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed