Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

Completed · Phase 3

Conditions studied: Internal Carotid Artery Stenosis, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT03121209

Run by

Columbia University

People needed

392

Starts

2018-01-18

Expected to finish

2025-07-31

Last updated by the study team

2026-06-26

Who can join

Age: 35 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled and randomized into CREST-2 (parent study)
• Inclusion criteria for CREST-2
• age 35-86
• Exclusion Criteria (in addition to the exclusion criteria for CREST-2):
• unable to undergo MRI (e.g. metal in body, pacemaker)
• known allergy gadolinium contrast dye
• pre-existing diagnosis of dementia
• contralateral ICA stenosis >70% by MRA, CTA or Doppler ultrasound
• history of severe head trauma
• major depression
• education less than 8 years

Where it is running

• 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
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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