NCT05300737Active, not recruiting
Symptomatic Carotid Outcomes Registry
Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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%.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 114 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 25 Sept 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Stroke
- NCT number
- NCT05300737
What you commit to
- Study type: Observational
- Planned participants: 114
- From 1 Aug 2022 to the primary completion date, 25 Sept 2026
- 18 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol and substance abuse within the prior 24 months
Other illness
- Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration <6 minutes
- Known allergy or intolerance to aspirin or clopidogrel
- Moderate/severe dementia (Mini-mental or MOCA score <22
Lab values
- Clinically significant bleeding diathesis (platelet count <100K, prothrombin time >14 seconds)
- Left ventricular ejection fraction <20%
Other
- Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)
- Life expectancy less than 12 months
- Modified Rankin score of >4
- Nonatherosclerotic cause of carotid stenosis
- Most recent symptomatic event >180 days from the time of enrollment
- -
Who the study is looking for
- 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:
- Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
- Female sex
- Most recent stroke or TIA >1 week ago
- Radiologic Reduced Stroke RISK:
- Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
- Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
- For patients with TIA: brain MRI shows no DWI lesion
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Calgary Health Sciences Center Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Northern Ontario School of Medicine Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| Western University/London Health Sciences Center Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Rush Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Baylor Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Baystate Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| University of Massachusetts Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.