At a glance
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics
In Brief
A Phase 3 clinical trial evaluating Revascularization and Intensive Medical Management (IMM) alone for Internal Carotid Artery Stenosis and Cognitive Impairment. Completed, enrolled 392 participants across 58 sites in 2 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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).
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.
Interventions
Patients in this arm are randomized to CEA/CAS plus IMM
Patients in this arm are randomized to intensive medical management (IMM) alone