Symptomatic Carotid Outcomes Registry

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Mar 18, 2022

Keywords

ClinConnect Summary

The Symptomatic Carotid Outcomes Registry is a clinical trial aimed at understanding how well Intensive Medical Therapy (IMT) can prevent strokes in patients who have a narrowing of the carotid artery (carotid stenosis) and have experienced symptoms like a stroke or transient ischemic attack (TIA). This study is important because it builds on earlier research from over 30 years ago, which didn't consider newer medications that are now commonly used to prevent strokes. The researchers hope to show that with the right medical treatment, the risk of having another stroke in these patients can be kept to less than 5% over one year.

To participate in this trial, individuals must be at least 40 years old and have had a stroke or TIA related to significant carotid artery narrowing (50-99%). They should also have certain low-risk factors that suggest a lower chance of future strokes, such as being female or having had their last stroke more than a week ago. Participants can expect close monitoring and care throughout the study. It’s important to note that certain health conditions, like severe heart issues or recent serious bleeding, may prevent someone from joining the trial. If you or a loved one meets the eligibility criteria, this study could provide valuable insights into stroke prevention.

Gender

ALL

Eligibility 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:
• • 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
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