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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 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.

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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.

Conditions Studied

Cognitive Impairment Internal Carotid Artery Stenosis

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

FieldValue
Enrollment Target 385 participants
Start Date 2018-01-18
Est. Completion 2027-07-31
Phase Phase 3

Sponsor

Columbia University

958 total trials

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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, categorized as Phase 3. The registered enrollment target is 385 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 662-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (42% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.