Registry for patients with symptomatic carotid stenosis
Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
This study is testing how well Intensive Medical Therapy alone can prevent strokes in patients with symptomatic carotid stenosis over one year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 17 sites (Hartford, Connecticut and 16 other locations) |
| Trial ID | NCT05300737 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the one-year stroke rate in patients with symptomatic carotid stenosis who are treated with Intensive Medical Therapy (IMT) alone. It builds on previous landmark trials by incorporating modern medical treatments such as statins and new antiplatelet agents. Participants will complete surveys at baseline, 6 months, and 12 months, with all data collected entered into a secure research registry. The study focuses on patients with low-risk clinical features to assess the effectiveness of current medical management strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who have experienced a stroke or TIA related to 50-99% ICA stenosis and exhibit low-risk clinical features.
Not a fit: Patients with atrial fibrillation or other high-risk sources of cardiac embolism, as well as those with significant bleeding disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Intensive Medical Therapy in reducing stroke rates for patients with symptomatic carotid stenosis.
How similar studies have performed: Previous studies have established the importance of medical therapy in stroke prevention, but this specific approach evaluating modern treatments in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Hartford, Connecticut and 16 other locations
- Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Rush Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Baystate Medical Center — Springfield, Massachusetts, United States (Recruiting)
- University of Massachusetts Medical Center — Worcester, Massachusetts, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- Baylor Medicine — Houston, Texas, United States (Recruiting)
- Calgary Health Sciences Center — Calgary, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- University of Manitoba — Winnipeg, Mn, Canada (Recruiting)
- Western University/London Health Sciences Center — London, Ontario, Canada (Recruiting)
- Northern Ontario School of Medicine — Sudbury, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Seemant Chaturvedi, MD — School of Medicine, University of Maryland
- Study coordinator: Christina Ecker, MA
- Email: CEcker@som.umaryland.edu
- Phone: 410-328-7602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.