Symptomatic Carotid Outcomes Registry

N/AActive Not RecruitingNCT05300737

University of Maryland, Baltimore114 enrolled

Overview

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%.

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.

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Carotid Stenosis Ischemic Stroke Transient Ischemic Attack

Interventions

intensive medical therapyOTHER

Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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 \-

Locations (18)

Hartford Hospital

Hartford, Connecticut, United States

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Ischemic stroke

ipsilateral to carotid stenosis, with radiologic confirmation

Time frame: within 12 months

Secondary Outcomes

Myocardial infarction

ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements

Time frame: within 12 months

Data from ClinicalTrials.gov

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