CREST-2: Medical study to prevent stroke caused by plaque buildup in carotid arteries
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The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis - Hemodynamics


CREST-H Study Principal Investigators

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​Randolph Marshall, MD, MS
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E. Sander Connelly, MD
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Ronald Lazar, PhD
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David Liebeskind, MD
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CREST-H addresses the intriguing question of whether cognitive impairment can be reversed by revascularization when cerebral blood flow is low on the side of a high grade carotid stenosis. 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 MRI perfusion (PWI) or CT perfusion (CTP) scan. 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. This treatment difference will be compared to revascularization versus medical therapy alone in those who do not have hemodynamic impairment.
​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.
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CREST-H Call for Participating Centers
Now that we have received NINDS funding for CREST-H we are contacting the top CREST-2 sites to enlist interest in participation in this critical ancillary study.
WHAT IS THE STUDY? There is evidence that patients with high grade carotid stenosis may have some cognitive impairment if they have low cerebral blood flow on the side of carotid occlusion. CREST-H will assess cognitive outcomes in patients with cerebral hypoperfusion and cognitive impairment, comparing those who get revascularized (CEA or CAS) versus those who get Intensive Medical Management alone.
WHAT WE NEED: To participate as a CREST-H site you must have:
  1. The capability to do gadolinium-based MR perfusion or CT perfusion on your CREST-2 patients before they get their procedure or prior to the 44-day CREST-2 follow-up visit if randomized to medical therapy alone. Other standard MRI images will also be obtained.
  2. 1.5T or 3.0T MRI scanner (3T preferred)
  3. A designated, independent co-investigator who can upload de-identified images to the CREST-2 imaging site at U Maryland.
WHAT YOU GET:
  1. $1,500 start-up to cover regulatory/IRB costs, and up to $2,925 per patient to cover imaging and CRF completion.
 
WHAT WE HOPE THE STUDY WILL ACCOMPLISH:
  1. An alternative indication for CEA/CAS even if CREST-2 shows no difference in stroke outcomes. The new indication is cognitive improvement in patients with high grade stenosis and flow impairment.
  2. Additional imaging data for CREST-2. In addition to MR perfusion data, we will be collecting MR data for silent infarction, collateral circulation, microbleeds and white matter hyperintensity volumes. 
56 participating sites enrolled a total of 364 subjects
crest-h_centers_list_01.09.24.pdf
File Size: 83 kb
File Type: pdf
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CREST-H Training
CREST-H_Training_Protocolv3.pdf
File Size: 851 kb
File Type: pdf
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CREST-H Protocol
crest-h_protocol_v3.2_06.20.23_clean_copy.docx
File Size: 400 kb
File Type: docx
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CREST-2/CREST-H Imaging MOP
vic_manual_of_procedures_v2.1_w_ctp_6.24.20.docx
File Size: 1626 kb
File Type: docx
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CREST-H Brochure
CREST-H_Brochure_09.18.18.pdf
File Size: 215 kb
File Type: pdf
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CREST-H Video
CREST-H Video
File Size: 11978 kb
File Type: mp4
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CREST-H on ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03121209
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