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NCT03121209 · ClinicalTrials.gov registry record · Phase 3
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
A Phase 3 study of Cognitive Impairment and Internal Carotid Artery Stenosis, sponsored by Columbia University.
- Active
- Registry status
- Phase 3
- Development phase
- 385
- Enrollment target
- 20
- Study locations
NCT03121209: Active Phase 3 study of Cognitive Impairment and Internal Carotid Artery Stenosis, sponsored by Columbia University.
NCT03121209 is a Phase 3 study of Cognitive Impairment and Internal Carotid Artery Stenosis that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 385 participants, below the 662-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121209, a Phase 3 study of Cognitive Impairment and Internal Carotid Artery Stenosis, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 385 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change in composite cognitive Z-score at 1 year will be computed from the cognitive battery of the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2; NCT02089217). Range: -2.0 to 2.0. Positive Z-score change indicates improvement; negative Z-score change indicates worsening.
Conditions Studied
Interventions
- PROCEDURE Revascularization
- OTHER Intensive Medical Management (IMM) alone
Study Locations (20)
California
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Keck Medical Center of University of Southern California - Los Angeles
- University of California at Los Angeles - Los Angeles
- Kaiser Permanente - San Diego
- University of California San Diego - San Diego
- San Francisco VA Medical Center - San Francisco
- Stanford University Medical Center - Stanford
Florida
- Morton Plant Hospital - Clearwater
- University of Florida Health at Shands - Gainesville
- Mayo Clinic Florida - Jacksonville
- University of Miami Hospital - Miami
Illinois
- University of Chicago - Chicago
- Northwestern University - Evanston
- Mercy Health Riverside - Rockford
Alabama
- The University of Alabama at Birmingham - Birmingham
- Huntsville Hospital/ Heart Center Research Alabama - Huntsville
Arizona
- St. Joseph's Hospital and Medical Center/ Barrow - Phoenix
- University of Arizona - Tucson
Arkansas
- Central Arkansas Veteran's Healthcare System - Little Rock
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 3 |
What the registry record for NCT03121209 still lists
NCT03121209 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 662-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Revascularization is the first listed.
NCT03121209 names 20 study sites across 7 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03121209 about?
NCT03121209 is a clinical study titled "Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)". 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...
What is the current status of trial NCT03121209?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 385 participants. The study started on 2018-01-18. Estimated completion is 2027-07-31.
What conditions does trial NCT03121209 study?
This clinical trial studies the following conditions: Cognitive Impairment, Internal Carotid Artery Stenosis.
What interventions are being tested in trial NCT03121209?
The interventions under investigation include: Revascularization (PROCEDURE), Intensive Medical Management (IMM) alone (OTHER).
Who is sponsoring clinical trial NCT03121209?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03121209 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03121209's enrollment target sits among peer trials
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