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

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ClinicalTrials.gov Identifier: NCT03121209

Recruitment Status : Recruiting

First Posted : April 20, 2017

Last Update Posted : May 3, 2024

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Sponsor:

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)

Mayo Clinic

University of Alabama at Birmingham

University of Maryland

University of California, Los Angeles

Information provided by (Responsible Party):

Randolph S. Marshall, MD, Columbia University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Internal Carotid Artery Stenosis Cognitive Impairment	Procedure: Revascularization Other: Intensive Medical Management (IMM) alone	Phase 3

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Detailed Description:

CREST-H sites will be drawn from actively-enrolling CREST-2 centers. The additional information obtained in CREST-H in this protocol will be the MR or CT imaging, which will be done at baseline for all patients enrolled in CREST-H, and at 1 year for those with hemodynamic impairment at baseline. The protocol will recommend an unblinded investigator at each CREST-H site who will order and obtain the study-related MRI sequences, upload de-identified image files to the CREST-2 central imaging site at U Maryland, and maintain blinding of the hemodynamic imaging data for their site (see Blinding below). Image analysis will be done at UCLA (for perfusion studies) and at Mayo Rochester for structural scans -- silent infarcts, WMH and microbleeds. Data management and statistical analysis will be done at UAB, which serves this role for CREST-2.

Cognitive Assessment.

CREST-H will use existing CREST-2 cognitive assessment infrastructure -- the Survey Research Unit at University of Alabama Birmingham. Added to the current CREST-2 battery is the Oral Trail Making A & B as an additional measure of executive function, which will be administered to every CREST-2 patient, regardless of their participation in CREST-H. Cognitive assessments in CREST-H must take place prior to revascularization or within two weeks after assignment to medical therapy alone. Testing in CREST-2 is repeated at 1 year, and every year thereafter up to 4 years. At each test interval, a composite (mean) Z-score is derived from published normative samples for each test outcome. The CREST-H primary outcome will be at 1 year in which the change in the composite Z-score from baseline will be calculated. Covariates will include age, education and depression. The test battery will be administered by a blinded assessor the same way for all CREST-2 and CREST-H enrolled patients. The cognitive domains being assessed in CREST-2/H are entirely consistent with those encompassed within the NINDS Common Data Elements (CDE).

Imaging protocol.

Multimodal MRI or CT perfusion imaging will be performed at baseline on every study subject.

Multimodal MRI, including routine parenchymal sequences and PWI utilizing dynamic susceptibility contrast technique, will be acquired at each participating CREST H site who have been approved for this imaging modality. CT perfusion, using iodinated contrast, will be used as an alternative PWI image for sites approved for this modality. Imaging will take place within 14 days after CREST-H enrollment and prior to any CREST 2 intervention for those randomized to CEA or CAS.

Standardized contrast agent injection protocol, appropriate preparation, and IV setup is used to ensure good scan quality. An antecubital vein IV catheter of 18-20 gauge is required. A test injection will be performed with approximately 10 ml of normal saline solution.

MRI image acquisition DWI/ADC (b=0, 1000 s/mm2 applied in each of three principal gradient directions), FLAIR, high-resolution T1, and GRE sequences will be acquired on 1.5-3.0 T scanners equipped with echo-planar imaging capability, using standard clinical protocols at participating CREST-H sites Total scanning time will be approximately 40 minutes. PWI acquisition protocol will be standardized across all CREST-H sites, using sequential T2*-weighted (gradient echo) EPI time sequence scanning. A modified 2-phase contrast injection scheme will be used to perform CEMRA and DSC perfusion imaging, without need for additional contrast.

CT perfusion imaging will follow the protocol outlined in the updated Imaging MOP for CREST-H. The CT perfusion study is identical to the clinical CTP protocol used for acute stroke imaging in most institutions.

Perfusion imaging analysis.

PWI source images will be sent to the core laboratory at UCLA and processed with the OleaSphere software platform, using deconvolution of tissue and arterial signals in an expedited manner, yielding standardized data regardless of the acquisition system at each site. Hemodynamic impairment is defined as TTP >1.25 sec in the middle cerebral artery and anterior cerebral artery territories of the ipsilateral hemisphere to the carotid lesion compared with the same territory in the opposite hemisphere. Longitudinal analyses will investigate the change in the TTP >1.25 sec lesion at 1 year comparing the revascularization versus the medical only arm. Continuous values for this volumetric change will be used to calculate the correlation between degree of cognitive change and degree of perfusion change. The continuous Tmax variable, as well as standard perfusion parameters of CBV, CBF Tmax, and MTT will be analyzed on the serial imaging studies in each case with MR imaging. Co-registered, voxel-based changes in serial perfusion values will also be explored with multiparametric (e.g. CBV, CBF, Tmax, MTT) values.

Image de-identification and blinding.

All MR or CT image files will be de-identified under the supervision of an unblinded Investigator (UI) at each institution and uploaded to the CREST-2 Imaging Core site at U Maryland. In order to assure that the PWI scan information from CREST-H does not compromise the integrity of the parent trial, the results of the perfusion scan will be blinded to the investigator team.

Image transfer.

Participating sites will utilize the same file transfer protocol (ftp) to transfer images to U Maryland for CREST-H as is already established for CREST-2. The images will be stored in a HIPAA-compliant, firewall protected server within the U Maryland archival system. A CREST-2 dedicated ftp linkage between the VIC at U Maryland and UCLA; and the VIC at U Maryland and Mayo-Rochester will be utilized to make each perfusion image file available for download by UCLA (Liebeskind lab) and each structural image (DWI, FLAIR, GRE) by Mayo-Rochester (Huston lab).

MRI structural analysis.

Structural MRI analysis at Mayo-Rochester will utilize NIH NINDS Common Data Elements developed for the CREST-2 grant. The following definitions apply:

silent infarct --- non-confluent hyperintense lesion >1mm on FLAIR sequence on 1-year MRI not present on baseline FLAIR MRI.
Cerebral microbleed - hypointense 1-2mm non-confluent lesion on baseline GRE sequence.
WMH volume -- White matter hyperintensity volume refers to confluent periventricular high intensity lesions on FLAIR imaging, and will be derived using an automated T2 WMH quantification at the Huston lab.

Data from image analysis (TTP delay, WMHV, silent infarct count, microbleed count) performed at UCLA and Mayo-Rochester will be entered electronically on CREST-H data forms via the CREST-2 SDCC website at UAB, where it will be stored on a separate webpage linked to the rest of the CREST-2 data, including baseline and yearly cognitive assessments. The electronic data entry system (eDES) for CREST-2 is a mature system, successfully reviewed by FDA audit in other studies, providing standard approaches for entry-confirmation-locking of data forms, and supporting range and validity checking for data provided.

. Analysis.

Specific Aim 1. To determine whether cognition can be improved by revascularization among a subset of CREST-2 patients with hemodynamic impairment at baseline.

The primary hypothesis is to assess if the magnitude of the treatment differences (revascularization versus medical management alone) differs between those with flow failure compared to those without flow failure using the Z-scored cognitive outcomes (C0, C(1). That is, the primary hypothesis is an interaction hypothesis that will be assessed using linear regression, specifically: (C1 - C0) = β0 + β1T + β2F + β3TF + β4C0 + (other covariates), where C1 is the cognitive z-score at year 1, C0 the cognitive z-score at baseline, T the treatment indicator variable, F the flow failure indicator variable, and βi the regression parameters to be estimated. The parameter of interest for the primary hypothesis is then β3 that would assess if the magnitude of treatment difference in the change in cognitive score between baseline and 1-year is similar for those with versus without flow failure.

Secondary Aims: To determine if the number of silent infarcts and white matter hyperintensity volume at 1 year is different between the revascularization and the medical-only arms.

For the secondary aims we will calculate the number of new silent cerebral infarctions occurring over the first year, and the change in the WMH volume. The approach for analysis of the number of new silent infarcts will depend on the average number and distribution of the number of new infarcts. The analytic approach will be linear regression if the number of new infarcts is large (considered more likely the case), or Poisson Regression if the number is smaller (considered less likely the case). The analysis of the change in WMH will use a linear regression approach.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	385 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Phase 3 prospective blinded outcome randomized clinical trial
Masking:	Single (Outcomes Assessor)
Masking Description:	single blind by outcomes assessor
Primary Purpose:	Prevention
Official Title:	Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics
Actual Study Start Date :	January 18, 2018
Estimated Primary Completion Date :	January 31, 2027
Estimated Study Completion Date :	July 31, 2027

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Revascularization Arm (CEA or CAS) These patients will have been randomized (via the parent trial, CREST-2) to receive intensive medical management as well as either Carotid Endarterectomy (CEA--if they are in the parent study Surgical trial) or Carotid Artery Stenting (CAS--if they are in the parent study Stenting trial).	Procedure: Revascularization Patients in this arm are randomized to CEA/CAS plus IMM
Active Comparator: Intensive Medical Management (IMM) Arm These patients will have been randomized (via the parent trial, CREST-2) to receive medical management only, which includes aspirin. high dose cholesterol lowering agent to a target LDL<70, intensive blood pressure management to target <130/80, smoking cessation, and diabetic control.	Other: Intensive Medical Management (IMM) alone Patients in this arm are randomized to intensive medical management (IMM) alone

Outcome Measures

Primary Outcome Measures :

Cognitive score at 1 year [ Time Frame: 1 year ]
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.

Secondary Outcome Measures :

MRI-determined silent infarcts present at 1 year that were not present at baseline. [ Time Frame: 1 year ]
A neuroradiology study investigator assesses for new silent infarcts as defined by any non-confluent hyperintense lesion >3mm on T2 FLAIR sequence on 1-year MRI not present on baseline T2 FLAIR MRI
Change from baseline of White matter hyperintensity (WMH) volume as measured by T2 FLAIR sequence on brain MRI. [ Time Frame: 1 year ]
A neuroradiology study investigator assesses for change in White matter hyperintensity (WMH) volume as defined by confluent periventricular high intensity lesions on T2 Fluid Attenuated Inversion Recovery (FLAIR) imaging.

Other Outcome Measures:

Cognitive score beyond 1 year [ Time Frame: 2, 3, and 4 years ]
Change in composite Z-score from baseline to 2-4 years on the CREST-2 cognitive battery. Range: -2.0 to 2.0. Positive Z-score change indicates improvement; negative Z-score change indicates worsening.
Correlation between change in cognition at 1 year, as measured in Outcome 1, and change in brain blood flow at 1 year as measured by time-to-peak (TTP) perfusion-weighted imaging (PWI) by MRI or computed tomography (CT). [ Time Frame: 1 year ]
Time-to-peak (TTP) perfusion weighted imaging (PWI) will be derived using a semi-automated software platform that computes quantitative perfusion maps.
Correlation of between change in cognition at 1 year and change in brain blood flow using other MRI PWI markers (CBF, CBV, Tmax). [ Time Frame: 1 year ]
CBF, CBV, and Tmax will be derived using a semi-automated software platform that computes quantitative perfusion maps.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years to 86 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121209

Contacts

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Contact: Kevin Slane, BA	212-342-1152	kjs4@cumc.columbia.edu

Locations

Show 56 study locations

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United States, Alabama
The University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Rhonda Whidden 205-934-2918 rwhidden@uabmc.edu
Principal Investigator: Veeranjaneyulu Prattipati, M.D.
Huntsville Hospital/ Heart Center Research Alabama	Recruiting
Huntsville, Alabama, United States, 35801
Contact: Weston Smith 256-698-0405 wsmith@hsvheartmds.com
Principal Investigator: Warren Strickland, M.D.
United States, Arizona
St. Joseph's Hospital and Medical Center/ Barrow	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Steev Mallon 602-406-4217 steev.mallon2@DignityHealth.org
Principal Investigator: Andrew Ducruet, M.D.
University of Arizona	Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Joshua Black 520-626-3576 joshuablack@email.arizona.edu
Principal Investigator: Wei Zhou, MD, FACS
United States, Arkansas
Central Arkansas Veteran's Healthcare System	Recruiting
Little Rock, Arkansas, United States, 72143
Contact: Sandi Brock, RN 501-257-6906 sjbrock@uams.edu
Principal Investigator: Mohammed Moursi, M.D.
United States, California
Kaiser Permanente Los Angeles Medical Center	Recruiting
Los Angeles, California, United States, 90027
Contact: Vena Sobhawongse 323-783-3093 Vena.S.Sobhawongse@kp.org
Principal Investigator: Navdeep Sangha, M.D.
Keck Medical Center of University of Southern California	Recruiting
Los Angeles, California, United States, 90033
Contact: Clare Binley 323-442-5710 Clare.Binley@med.usc.edu
Principal Investigator: Sebina Bulic, M.D.
University of California at Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Contact: Gabriela Flores 310-206-1115 GabrielaFlores@mednet.ucla.edu
Principal Investigator: Wesley S. Moore, M.D.
Kaiser Permanente	Recruiting
San Diego, California, United States, 92123
Contact: Stephanie Martinez 858-266-6602 stephanie.m1.martinez@kp.org
Principal Investigator: Edward Plecha, MD
University of California San Diego	Recruiting
San Diego, California, United States, 92182
Contact: Peter Chase pchase@health.ucsd.edu
Principal Investigator: Alexander A Khalessi, MD
San Francisco VA Medical Center	Recruiting
San Francisco, California, United States, 94121
Contact: Sandra Perez 415-221-4810 ext 22697 sandra.perez@va.gov
Principal Investigator: Joseph Rapp, M.D.
Stanford University Medical Center	Recruiting
Stanford, California, United States, 94305
Contact: Guiping Qin 650-721-5329 gqin68@stanford.edu
Principal Investigator: Gary Steinberg, M.D.
United States, Connecticut
Yale New Haven Hospital	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jackie Gamberdella 203-737-1899 Jacqueline.Gamberdella@yale.edu
Principal Investigator: Carlos Mena-Hurtado, M.D.
United States, Florida
Morton Plant Hospital	Recruiting
Clearwater, Florida, United States, 33756
Contact: Shawna Miller 727-461-8885 shawna.miller@baycare.org
Principal Investigator: Eric Lopez del Valle, M.D.
University of Florida Health at Shands	Recruiting
Gainesville, Florida, United States, 32610
Contact: Teresa Lyles 352-294-5693 Teresa.Lyles@neurology.ufl.edu
Principal Investigator: Anna Khanna, M.D.
Mayo Clinic Florida	Recruiting
Jacksonville, Florida, United States, 322224
Contact: Alexandra Kropnick 904-953-2077 Kropnick.Alexandra@mayo.edu
Principal Investigator: Albert Hakaim, M.D.
University of Miami Hospital	Recruiting
Miami, Florida, United States, 33136
Contact: Andrea Escobar, MPH 305-243-8876 aescobar@med.miami.edu
Principal Investigator: Amer Malik, M.D.
United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Cedric McKoy, MSN, ACNP 773-702-7215 jbrorson@neurology.bsd.uchicago.edu
Principal Investigator: James Brorson, M.D.
Northwestern University	Recruiting
Evanston, Illinois, United States, 60208
Contact: Ayesha Muzaffar 312-926-4251 ayesha.muzaffar@northwestern.edu
Principal Investigator: Sameer Ali, M.D.
Mercy Health Riverside	Recruiting
Rockford, Illinois, United States, 61114
Contact: Nicole Morud, DNP RN 815-971-1877 nmorud@mhemail.org
Principal Investigator: Vibhav Bansal, MD
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Judith Pena-Quevedo 319-353-8736 judith-pena-quevedo@uiowa.edu
Principal Investigator: Mel Sharafuddin, M.D.
United States, Louisiana
Ochsner Health System	Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Shannon Williams 504-842-6487 slwilliams@ochsner.org
Principal Investigator: Charles Sternbergh III, M.D.
United States, Maine
Maine Medical Center	Recruiting
Portland, Maine, United States, 04102
Contact: Debbie Cushing 207-885-4438 cushid@mmc.org
Principal Investigator: Robert Ecker, M.D.
United States, Maryland
University of Maryland VA	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dawn Barth dbarth@som.umaryland.edu
Principal Investigator: Shahab Toursavadkohi, M.D.
Adventist HealthCare/White Oak Medical Center	Recruiting
Gaithersburg, Maryland, United States, 20878
Contact: Tamika Magee 301-891-5493 tmagee@adventisthealthcare.com
Principal Investigator: Fayaz Shawl, M.D.
United States, Michigan
Michigan Vascular Center/McLaren-Flint	Recruiting
Flint, Michigan, United States, 48532
Contact: Maureen Blewett 810-600-2009 maureena@michiganvascular.com
Principal Investigator: Robert Molnar, M.D.
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amanda Weller 612-301-1593 andv0003@umn.edu
Principal Investigator: Andy Grande, M.D.
Mayo Clinic Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Yeoniee Kim 507-293-1963 Kim.Yeoniee@mayo.edu
Principal Investigator: Giuseppe Lanzino, M.D.
United States, Missouri
Mercy Hospital St Louis	Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jessica Schulte 314-251-5916 Jessica.Schulte@Mercy.Net
Principal Investigator: Scott Westfall, M.D.
United States, New York
SUNY Buffalo	Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Hartney 716-888-4812 mhartney@ubns.com
Principal Investigator: Adnan Siddiqui, MD, PhD
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Randolph S Marshall, MD 212-305-8389 rsm2@columbia.edu
Contact: Ryan D Lichtcsein 212-342-8658 rdl2116@columbia.edu
Principal Investigator: Ronald M Lazar, PhD
Principal Investigator: E Sander Connolly, MD
Principal Investigator: David S Liebeskind, MD
New York Presbyterian Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Jose Gutierrez, MD 212-305-1710 jg3233@cumc.columbia.edu
Contact: Kevin J Slane, BA 2123421152 kjs4@cumc.columbia.edu
Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10065
Contact: Carla Sherman 212-746-6757 cas9149@med.cornell.edu
Principal Investigator: Dana Leifer, MD
United States, North Carolina
Novant Health Forsythe	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Olga Dubangiu 336-718-5871 odubangiu@novanthealth.org
Principal Investigator: Donald Heck, MD
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Krystal Schmidt 336-716-9603 kschmidt@wakehealth.edu
Principal Investigator: Cheryl Bushnell, M.D.
United States, Ohio
Louis Stokes Cleveland VA Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa Tucker 216-791-3800 ext 3595 lisa.tucker@va.gov
Principal Investigator: Svetlana Pundik, M.D.
University Hospitals Cleveland Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Linette Mercer, BSN RN 216-844-3013 Linette.Mercer@UHhospitals.org
Principal Investigator: Norman H Kumins, M.D.
Ohio State Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Roderick Liptrot 614-293-8536 Roderick.Liptrot@osumc.edu
Principal Investigator: Jean Starr, M.D.
Ohio Health Research Institute	Recruiting
Columbus, Ohio, United States, 43214,
Contact: Amanda Bliemeister 614-566-1268 Amanda.Bliemeister@OhioHealth.com
Principal Investigator: Gary Ansel, M.D.
United States, Pennsylvania
UPMC Altoona	Recruiting
Altoona, Pennsylvania, United States, 16601
Contact: Jason Weimer weimerjm@upmc.edu
Principal Investigator: Cynthia Kenmuir, MD
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nichole Gallatti 215-349-8651 nichole.gallatti@uphs.upenn.edu
Principal Investigator: Michael Mullen, M.D.
UPMC Presbyterian University Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Cathy Van Every 412-647-7099 vaneverycc@upmc.edu
Principal Investigator: Marcelo Rocha, M.D.
United States, Rhode Island
The Miriam Hospital/ Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Wendy Smith 401-793-4105 WSmith@Lifespan.org
Principal Investigator: Gaurav Jindal, M.D.
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vicki Streets 814-490-7034 streetsv@musc.edu
Principal Investigator: Christine Holmstedt, M.D.
United States, South Dakota
North Central Heart Institute	Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Patty Eisenbraun 605-977-5336 peisenbraun@ncheart.com
Principal Investigator: Michael Bacharach, M.D.
United States, Tennessee
Tennova Healthcare/ Turkey Creek Medical Center	Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Nancy Bradley, RN, CCRC 865-218-7538 nancy.bradley@tennova.com
Principal Investigator: Malcolm Foster, M.D.
United States, Texas
Houston Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Jason Lee 832-236-9396 jlee5@houstonmethodist.org
Principal Investigator: David Chiu, M.D.
United States, Utah
University of Utah Hospitals and Clinics	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kinga Aitken 801-581-5523 kinga.aitken@hsc.utah.edu
Principal Investigator: Jennifer Majersik, M.D.
United States, Virginia
University of Virginia Health System	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Caryn Wolf 434-924-9271 CLW8PV@hscmail.mcc.virginia.edu
Principal Investigator: Avery Evans, M.D.
Inova Fairfax Health Care	Recruiting
Falls Church, Virginia, United States, 22042
Contact: Renee Mercier 703-776-8425 Renee.Mercier@inova.org
Principal Investigator: Dipankar Mukherjee, M.D.
United States, Washington
University of Washington Medicine-Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: Hope Clark-Bell 206-744-9457 Hoper555@uw.edu
Principal Investigator: David Tirschwell, M.D.
VA Puget Sound Health Care System	Recruiting
Seattle, Washington, United States, 98108
Contact: Susan Bigda 206-277-4681 susan.bigda@va.gov
Principal Investigator: Gale Tang, M.D.
United States, Wisconsin
Gundersen Clinic, Ltd	Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Sara Meyers 608-775-0238 SRMeyers@gundersenhealth.org
Principal Investigator: Clark Davis, M.D.
University of Wisconsin Hospital and Clinics	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Bridget Johnson 608-265-4420 johnsonbri@surgery.wisc.edu
Principal Investigator: Girma Tefera, M.D.
Canada, British Columbia
Vancouver General Hospital	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Genoveva Maclean,, BA, BSN, RN 604-875-4554 genoveva@bcstrokecentre.ca
Principal Investigator: Philip Teal, M.D.
Canada, Manitoba
St. Boniface Hospital	Recruiting
Winnipeg, Manitoba, Canada, MB R2H 2A6
Contact: Wendy Weighell 204-235-3916 wweighell@sbgh.mb.ca
Principal Investigator: Randolph Guzman, M.D.

Sponsors and Collaborators

Columbia University

National Institute of Neurological Disorders and Stroke (NINDS)

Mayo Clinic

University of Alabama at Birmingham

University of Maryland

University of California, Los Angeles

Investigators

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Principal Investigator:	Randolph S Marshall, MD	Columbia University

More Information

Publications:

Marshall RS, Lazar RM, Liebeskind DS, Connolly ES, Howard G, Lal BK, Huston J 3rd, Meschia JF, Brott TG. Carotid revascularization and medical management for asymptomatic carotid stenosis - Hemodynamics (CREST-H): Study design and rationale. Int J Stroke. 2018 Dec;13(9):985-991. doi: 10.1177/1747493018790088. Epub 2018 Aug 22.

Marshall RS, Liebeskind DS, Iii JH, Edwards LJ, Howard G, Meschia JF, Brott TG, Lal BK, Heck D, Lanzino G, Sangha N, Kashyap VS, Morales CD, Cotton-Samuel D, Rivera AM, Brickman AM, Lazar RM. Cortical Thinning in High-Grade Asymptomatic Carotid Stenosis. J Stroke. 2023 Jan;25(1):92-100. doi: 10.5853/jos.2022.02285. Epub 2023 Jan 3.

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Responsible Party:	Randolph S. Marshall, MD, Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier:	NCT03121209
Other Study ID Numbers:	AAAR5617 1R01NS097876-01A1 ( U.S. NIH Grant/Contract )
First Posted:	April 20, 2017 Key Record Dates
Last Update Posted:	May 3, 2024
Last Verified:	April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
Supporting Materials:	Study Protocol
Time Frame:	As per NIH/NINDS requirements.
Access Criteria:	All items required by NIH/NINDS will be publicly shared.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Carotid Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases

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