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

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2020 · $617,741

## Abstract

Cerebral hemodynamic impairment due to high-grade carotid artery stenosis can impair cognition
even in the absence of stroke, contributing to cognitive decline either directly, or as a consequence
of a higher occurrence of silent infarction. Although there is good preliminary evidence from case
series and physiological studies that hemodynamic impairment affects cognition in patients with
carotid occlusive disease, treatment of this condition has never been tested in a randomized clinical
trial. We propose to conduct an ancillary study to the NINDS-sponsored CREST-2 trial, a pair of
outcome-blinded, Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery
stenosis which will compare carotid endarterectomy plus optimal medical therapy (OMT) versus
OMT alone (n=1,240), and carotid artery stenting plus OMT versus OMT alone (n=1,240) to prevent
stroke and death. . Our application 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 500
patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly
thereafter. We will identify 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 assigned to
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

- **NIH application ID:** 9923010
- **Project number:** 5R01NS097876-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** EDWARD SANDER CONNOLLY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $617,741
- **Award type:** 5
- **Project period:** 2017-05-15 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9923010

## Citation

> US National Institutes of Health, RePORTER application 9923010, Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H) (5R01NS097876-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9923010. Licensed CC0.

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