Clinical trial NCT05465122: CREST-2 Long-term Observational Extension Study
Official title: Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Stenoses, Carotid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Alabama at Birmingham
name: University of Maryland
name: Medical University of South Carolina
First posted: 2022-07-19
Enrollment: 2480
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asymptomatic carotid stenosis previously randomized in the CREST-2 trial.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Stroke
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Pheonix
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas VA
state: Arkansas
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC/Keck Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Divsion of Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Mortan Plant Mease Healthcare
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health at Shands
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery/Baptist Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute NW Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart/St. John's Hospital
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Heart Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: Baptist Health
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: VA Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Silver Spring
country: United States
facility: White Oak Medical Center
state: Maryland
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Golden Valley
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Toledo
country: United States
facility: Mercy Health St. Vincent
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Knoxville
country: United States
facility: Tennova Healthcare
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah Hospitals & Clinics
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound
state: Washington
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Mayo Clinic
name: James Meschia, MD
role: PRINCIPAL_INVESTIGATOR
References: