Symptomatic Carotid Outcomes Registry With Multi-center Evaluation

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Observational
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%.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

‣ 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

Locations
United States
Connecticut
Hartford Hospital
RECRUITING
Hartford
Georgia
Emory University Hospital
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Rush Medical Center
RECRUITING
Chicago
Massachusetts
Baystate Medical Center
RECRUITING
Springfield
University of Massachusetts Medical Center
RECRUITING
Worcester
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
New York
University of Rochester
RECRUITING
Rochester
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
Baylor Medicine
RECRUITING
Houston
Other Locations
Canada
Calgary Health Sciences Center
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
Northern Ontario School of Medicine
RECRUITING
Greater Sudbury
Western University/London Health Sciences Center
RECRUITING
London
CHUM
RECRUITING
Montreal
Vancouver General Hospital
RECRUITING
Vancouver
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Christina Ecker, MA
CEcker@som.umaryland.edu
410-328-7602
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 114
Treatments
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
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov