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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
NCT03121209 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03121209
The ClinicalTrials.gov registry entry for NCT03121209 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 385 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03121209 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03121209?
The interventions under investigation include: Revascularization (PROCEDURE), Intensive Medical Management (IMM) alone (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03121209?
This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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