Symptomatic Carotid Outcomes Registry (SCORE)

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Ischemic Stroke; Carotid Stenosis; Transient Ischemic Attack

Treatments: Other: intensive medical therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05300737

00088344-2

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

114 participants in 1 patient group

Symptomatic carotid stenosis with low risk features

Description:

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

Treatment:

Other: intensive medical therapy