ACTIVE_NOT_RECRUITING

Symptomatic Carotid Outcomes Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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%.

Official Title

Symptomatic Carotid Outcomes Registry With Multi-center Evaluation

Quick Facts

Study Start:2022-08-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05300737

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥40 years plus stroke or TIA ipsilateral to 50-99% ICA stenosis
  2. 1. Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
  3. 2. Female sex
  4. 3. Most recent stroke or TIA \>1 week ago
  5. 1. Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
  6. 2. Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
  7. 3. For patients with TIA: brain MRI shows no DWI lesion
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Seemant Chaturvedi, MD
PRINCIPAL_INVESTIGATOR
School of Medicine, University of Maryland

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06102
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush Medical Center
Chicago, Illinois, 60612
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
United States
University of Rochester
Rochester, New York, 14642
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Baylor Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Seemant Chaturvedi, MD, PRINCIPAL_INVESTIGATOR, School of Medicine, University of Maryland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Carotid Stenosis
  • Ischemic Stroke
  • Transient Ischemic Attack