Summary

Eligibility
for people ages 35 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

Official Title

Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial

Details

Atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all ischemic strokes. The ongoing NINDS-funded CREST-2 multicenter randomized clinical trial is testing whether in the short term (up to 4 years after study entry) procedural revascularization improves stroke prevention above and beyond what can be achieved with intensive medical management of vascular risk factors, especially hypertension and hyperlipidemia. Our proposal is for an observational extension of the CREST-2 clinical trial to test whether revascularization improves stroke prevention in the clinically relevant long term (up to 8 to 10 years). The current application proposes to use a site-less, centralized telephone approach to extend the follow-up of CREST-2 trial participants for assessing the primary study outcome (stroke) for up to 10 years. The average follow-up will increase from between 2-3 years (clinic-based randomized trial) to 7-8 years (observational extension). Each patient will be contacted by telephone at 6-month intervals, and queried regarding all hospitalizations since the last contact. Suspected stroke events will be adjudicated by an expert clinical events committee based on medical record review.

Keywords

Stenoses, Carotid, Carotid Stenosis, Carotid Endarterectomy, FDA-approved carotid stents, Intensive Medical Management

Eligibility

You can join if…

Open to people ages 35 years and up

  • Currently active or graduated participants in the CREST-2 randomized trial
  • Able to provide written informed consent by self
  • Fluent in English or Spanish

You CAN'T join if...

  • Unable to provide written informed consent
  • Inability to follow study procedures

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • Kaiser Permanente Los Angeles
    Los Angeles California 90027 United States
  • USC/Keck Medical Center
    Los Angeles California 90033 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
ID
NCT05465122
Study Type
Observational
Participants
Expecting 2480 study participants
Last Updated