Symptomatic Carotid Outcomes Registry

Recruiting

• Conditions: Ischemic Stroke; Transient Ischemic Attack; Carotid Stenosis
• Interventions: Other: intensive medical therapy

• Registration Number: NCT05300737
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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%.

Detailed Description

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 Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2022-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic carotid stenosis with low risk features	intensive medical therapy	50-99% symptomatic carotid stenosis with low clinical or radiologic risk features (see inclusion criteria) Patients will receive intensive medical therapy, including dual antiplatelet therapy, high potency statins, BP control, and lifestyle modification

Primary Outcome Measures

Name	Time	Method
Ischemic stroke	within 12 months	ipsilateral to carotid stenosis, with radiologic confirmation

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	within 12 months	ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements

Trial Locations

Locations (17)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Rush Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

University of Massachusetts Medical Center; 🇺🇸 Worcester, Massachusetts, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Baylor Medicine; 🇺🇸 Houston, Texas, United States

Calgary Health Sciences Center; 🇨🇦 Calgary, Alberta, Canada

University of Manitoba; 🇨🇦 Winnipeg, MN, Canada

Western University/London Health Sciences Center; 🇨🇦 London, Ontario, Canada

Northern Ontario School of Medicine; 🇨🇦 Sudbury, Ontario, Canada