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Symptomatic Carotid Outcomes Registry

Ischemic Stroke | Transient Ischemic Attack | Carotid Stenosis

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%.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    40 and up

Critères de participation

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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Lieu de l'étude

Calgary Health Sciences Center
Calgary Health Sciences Center
Calgary, Alberta
Canada

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Primary Contact

Bijoy Menon, MD

Western University/London Health Sciences Center
Western University/London Health Sciences Center
London, Ontario
Canada

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Primary Contact

Luciano Sposato, MD

University of Manitoba
University of Manitoba
Winnipeg, MN
Canada

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Primary Contact

Nishita Singh, MBBS

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

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Primary Contact

Brian Buck, MD

Northern Ontario School of Medicine
Northern Ontario School of Medicine
Sudbury, Ontario
Canada

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Primary Contact

Serena Saini

Vancouver General Hospital
Vancouver General Hospital
Vancouver, British Columbia
Canada

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Primary Contact

Thalia Field, MD

Étude parrainée par
University of Maryland, Baltimore
Participants recherchés
Plus d'informations
ID de l'étude: NCT05300737