Cognitive Outcome After Carotid Surgery
Completed
Conditions studied: Carotid Stenosis
In brief
The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or worsening of thinking or memory. There have been many studies on this subject, some finding that certain patients gain improvement in their brain function and others might get worse. The goal of this study is to discover which patients are more likely to have improved cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and stenting (CAS) are not investigational and are an accepted treatment for your condition. In addition, subjects that choose not to undergo surgery will also be included in this study.
Key facts
- Study ID
- NCT02118233
- Run by
- Lahey Clinic
- People needed
- 56
- Starts
- 2014-04-01
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2019-11-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
- Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)
You may not qualify if…
- Patients with prior large vessel infarct
- Patients with intracranial stenosis
- Patients with major depression
- Patients with Alzheimer disease (clinically defined or Wechsler IQ <80)
- Patients who have had previous ipsilateral carotid surgery
- Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).
- Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.
Where it is running
- Lahey Clinic, Inc. — Burlington, Massachusetts, United States
- University of Buffalo Neurosurgery (UBNS) — Buffalo, New York, United States
- StonyBrook — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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