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The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis - Hemodynamics |
CREST-H Study Principal Investigators
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 500 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.
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 500 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:
WHAT WE HOPE THE STUDY WILL ACCOMPLISH:
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58 participating sites enrolled a total of 294 subjects
CREST-H Training
CREST-H Protocol
CREST-2/CREST-H Imaging MOP
CREST-H Brochure
CREST-H Video
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CREST-H on ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03121209