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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
Sponsor: Columbia University
Summary
We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 385 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.
Official title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics
Key Details
Gender
All
Age Range
35 Years - 86 Years
Study Type
INTERVENTIONAL
Enrollment
385
Start Date
2018-01-18
Completion Date
2027-07-31
Last Updated
2025-09-26
Healthy Volunteers
No
Interventions
Revascularization
Patients in this arm are randomized to CEA/CAS plus IMM
Intensive Medical Management (IMM) alone
Patients in this arm are randomized to intensive medical management (IMM) alone
Locations (58)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Huntsville Hospital/ Heart Center Research Alabama
Huntsville, Alabama, United States
St. Joseph's Hospital and Medical Center/ Barrow
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Keck Medical Center of University of Southern California
Los Angeles, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Kaiser Permanente
San Diego, California, United States
University of California San Diego
San Diego, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Florida Health at Shands
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami Hospital
Miami, Florida, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Mercy Health Riverside
Rockford, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Ochsner Health System
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland VA
Baltimore, Maryland, United States
Adventist HealthCare/White Oak Medical Center
Gaithersburg, Maryland, United States
Michigan Vascular Center/McLaren-Flint
Flint, Michigan, United States
Minneapolis Clinic of Neurology, Ltd./ North Memorial Medical Center
Golden Valley, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Mercy Hospital St Louis
St Louis, Missouri, United States
SUNY Buffalo
Buffalo, New York, United States
New York Presbyterian Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Novant Health Forsythe
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State Medical Center
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
UPMC Altoona
Altoona, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States
The Miriam Hospital/ Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
North Central Heart Institute
Sioux Falls, South Dakota, United States
Tennova Healthcare/ Turkey Creek Medical Center
Knoxville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inova Fairfax Health Care
Falls Church, Virginia, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
University of Washington Medicine-Harborview Medical Center
Seattle, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Gundersen Clinic, Ltd
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada