Symptomatic Carotid Outcomes Registry

Ischemic Stroke Clinical Trial

— SCORE  

Official title:

Symptomatic Carotid Outcomes Registry With Multi-center Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300737
• Other study ID #: 00088344-2
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: Christina Ecker, MA
• Phone: 410-328-7602
• Email: CEcker[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Carotid Stenosis
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Transient Ischemic Attack

Intervention

Other:
• intensive medical therapy
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification

Locations

Country	Name	City	State
Canada	Calgary Health Sciences Center	Calgary	Alberta
Canada	Western University/London Health Sciences Center	London	Ontario
Canada	Northern Ontario School of Medicine	Sudbury	Ontario
Canada	University of Manitoba	Winnipeg	MN
Denmark	Zealand University Hospital	Køge
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Rush Medical Center	Chicago	Illinois
United States	Baylor Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Oregon Health Sciences Center	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Baystate Medical Center	Springfield	Massachusetts
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Countries where clinical trial is conducted

United States,  Canada,  Denmark, 

References & Publications (4)

Chaturvedi S. Treatment of a hot carotid: More fuel is needed to clarify the best treatments. Neurol Clin Pract. 2018 Dec;8(6):466-467. doi: 10.1212/CPJ.0000000000000561. No abstract available. — View Citation

King A, Markus HS. Doppler embolic signals in cerebrovascular disease and prediction of stroke risk: a systematic review and meta-analysis. Stroke. 2009 Dec;40(12):3711-7. doi: 10.1161/STROKEAHA.109.563056. Epub 2009 Oct 22. — View Citation

Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi — View Citation

Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke	ipsilateral to carotid stenosis, with radiologic confirmation	within 12 months
Secondary	Myocardial infarction	ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements	within 12 months