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Symptomatic Carotid Outcomes Registry (SCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05300737
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Seemant Chaturvedi, 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%.

Condition or disease Intervention/treatment
Carotid Stenosis Ischemic Stroke Transient Ischemic Attack Other: intensive medical therapy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : October 2025

Group/Cohort Intervention/treatment
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
Other: intensive medical therapy
Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification




Primary Outcome Measures :
  1. Ischemic stroke [ Time Frame: within 12 months ]
    ipsilateral to carotid stenosis, with radiologic confirmation


Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: within 12 months ]
    ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with 50-99% symptomatic carotid stenosis and low risk clinical or radiologic features
Criteria

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 >2 weeks 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

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 >3

Nonatherosclerotic cause of carotid stenosis

Most recent symptomatic event >180 days from the time of enrollment

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05300737


Contacts
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Contact: Christina Spadafora, MA 410-328-7602 Cspadafora@som.umaryland.edu

Locations
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United States, Florida
UF Jacksonville Health Recruiting
Jacksonville, Florida, United States, 32209
Contact: Scott Silliman, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Seemant Chaturvedi, MD         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Rajiv Padmanabhan, MD         
University of Massachusetts Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Brian Silver, MD         
United States, Ohio
Ohio State Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Deepak Gulati, MD         
United States, Oregon
Oregon Health Sciences Center Recruiting
Portland, Oregon, United States, 97239
Contact: Helmi Lutsep, MD         
United States, Texas
Baylor Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Rahul Damani, MD         
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Seemant Chaturvedi, MD School of Medicine, University of Maryland
Publications of Results:
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Responsible Party: Seemant Chaturvedi, Professor of Neurology, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT05300737    
Other Study ID Numbers: 00088344-2
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Ischemic Attack, Transient
Carotid Stenosis
Ischemia
Pathologic Processes
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Carotid Artery Diseases
Arterial Occlusive Diseases