Carotid StenosisSCORENCT05300737
Symptomatic Carotid Outcomes Registry
An observational study of Carotid Stenosis and Ischemic Stroke, run by University of Maryland, Baltimore at 18 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- intensive medical therapy
- How many people
- 114 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 1 Aug 2022to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with 50-99% symptomatic carotid stenosis and low risk clinical or radiologic features
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States11 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush Medical Center
Chicago, Illinois, 60612
Hartford Hospital
Hartford, Connecticut, 06102
Baylor Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester
Rochester, New York, 14642
Baystate Medical Center
Springfield, Massachusetts, 01199
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Canada7 sites
Calgary Health Sciences Center
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Northern Ontario School of Medicine
Greater Sudbury, Ontario
Western University/London Health Sciences Center
London, Ontario
CHUM
Montreal, Quebec, H2X 0C1
Vancouver General Hospital
Vancouver, British Columbia
University of Manitoba
Winnipeg, MN
About this study
Official title: Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
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%.
Read the 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.
- Conditions
- Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack
- Being tested
- intensive medical therapy
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive medical therapyOther
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic carotid stenosis with low risk features | 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 Receives: Other: intensive medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
ipsilateral to carotid stenosis, with radiologic confirmation
Measured: within 12 months
Secondary outcomes (1)
Myocardial infarction
ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seemant Chaturvedi, University of Maryland, Baltimore
- Investigators
- Seemant Chaturvedi, MD, Principal investigator, School of Medicine, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300737
- Sponsor's protocol ID
- 00088344-2
- Acronym
- SCORE
- Status last verified
- Oct 2025
- First submitted
- 9 Mar 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19850894Chaturvedi 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.
PubMed 30588374Saba 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. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
PubMed 30954372Rothwell 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: 10.1016/S0140-6736(04)15785-1.
PubMed 15043958
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
- ClinicalTrials.gov ID
- NCT05300737
- Acronym / sponsor ID
- SCORE / 00088344-2
- Conditions
- Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic carotid stenosis with low risk features | – | Other: intensive medical therapy50-99% 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 50-99% symptomatic carotid stenosis and low risk clinical or radiologic features
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive medical therapyDual antiplatelet therapy, high potency statins, HTN control, lifestyle modification | Other | Symptomatic carotid stenosis with low risk features |
Primary outcome
Ischemic stroke
Time frame: within 12 months
ipsilateral to carotid stenosis, with radiologic confirmation
1 secondary outcome
Myocardial infarction
Time frame: within 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Results publication: PubMed 19850894King 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.
- Results publication: PubMed 30588374Chaturvedi 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.
- Results publication: PubMed 30954372Saba 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. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
- Results publication: PubMed 15043958Rothwell 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: 10.1016/S0140-6736(04)15785-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seemant Chaturvedi, MD principal investigator
School of Medicine, University of Maryland
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis and Ischemic Stroke, run by University of Maryland, Baltimore at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic stroke (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.