Stroke Clinical Trial
— NIA-SCOREOfficial title:
Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly
Verified date | May 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes per year in the US an incidence more than twice the annual occurrence of ruptured intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3). Symptomatic COICA subjects are at increased risk of developing cognitive impairment and progressive development of vascular dementia and AD with time. Our proposal leverages several compelling retrospective and prospective preliminary data from human to perform this exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated
Status | Completed |
Enrollment | 33 |
Est. completion date | March 14, 2024 |
Est. primary completion date | March 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age = 21 - Complete occlusion of cervical ICA on imaging studies (MRA or CTA) and confirmed with DSA - History of TIA or stroke - Increased MTT and/or time to peak (TTP) on CT perfusion as defined as T Max threshold of > 10cc > 4 seconds in the territory of the occluded carotid specifically in the MCA territory when compared to the opposite unaffected hemisphere (not required for observational cohort) - All occlusion is due to atherosclerotic disease - MoCA < 26 or abnormal result on another test in the battery (abnormal defined as 1.5 SD below age/ gender/ education matched norms). - Baseline MoCA assessed by the neurosurgery team or neuropsychology team - Failed best medical treatment (defined below) - Class A and B on COICA Classification - Study team able to gain consent from subject or legal adult representative (LAR) Exclusion Criteria: - Non-atherosclerotic occlusive disease that may have caused the occlusion, including moyamoya, dissection, trauma or other causes - Tandem occlusion - No evidence of penumbra on CT perfusion - Severe co-morbid diseases: Chronic Kidney Disease (CKD) stages 4 or 5, end-stage renal disease, liver cirrhosis; Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen; terminal illness such as cancer; Parkinson disease or other neurodegenerative diseases; severe congestive heart failure; seizures; debilitating stroke, Modified Rankin Score (mRS) = 3 - Short life expectancy due to cancer or other co-morbid diseases - Class D on COICA classification - Normal neuropychological battery test results - Subject unwilling to randomized to surgical procedure - Pregnant or risk of becoming pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
United States | University of Iowa hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Hudson JS, Zanaty M, Wadman V, Nakagawa D, Ishii D, Roa JA, Al Kasabz S, Limaye K, Rossen JD, Jabbour P, Adams HP Jr, Samaniego EA, Hasan DM. Bradycardia and Asystole in Patients Undergoing Symptomatic Chronically Occluded Internal Carotid Artery Recanalization. World Neurosurg. 2019 Nov;131:e211-e217. doi: 10.1016/j.wneu.2019.07.125. Epub 2019 Jul 23. — View Citation
Limaye K, Zanaty M, Hudson J, Nakagawa D, Al Kasab S, Alvarez C, Dandapat S, Kung DK, Ortega-Gutierrez S, Jabbour P, Samaniego EA, Hasan D. The Safety and Efficacy of Continuous Tirofiban as a Monoantiplatelet Therapy in the Management of Ruptured Aneurysms Treated Using Stent-Assisted Coiling or Flow Diversion and Requiring Ventricular Drainage. Neurosurgery. 2019 Dec 1;85(6):E1037-E1042. doi: 10.1093/neuros/nyz226. — View Citation
Zanaty M, Howard S, Roa JA, Alvarez CM, Kung DK, McCarthy DJ, Samaniego EA, Nakagawa D, Starke RM, Limaye K, Al Kasab S, Chalouhi N, Jabbour P, Torner J, Tranel D, Hasan D. Cognitive and cerebral hemodynamic effects of endovascular recanalization of chronically occluded cervical internal carotid artery: single-center study and review of the literature. J Neurosurg. 2019 Mar 29;132(4):1158-1166. doi: 10.3171/2019.1.JNS183337. — View Citation
Zanaty M, Roa JA, Jabbour PM, Samaniego EA, Hasan DM. Recanalization of the Chronically Occluded Internal Carotid Artery: Review of the Literature. World Neurosurg X. 2019 Nov 21;5:100067. doi: 10.1016/j.wnsx.2019.100067. eCollection 2020 Jan. — View Citation
Zanaty M, Samaniego EA, Hasan DM. Letter to the Editor Regarding "Estimation and Recanalization of Chronic Occluded Internal Carotid Artery: Hybrid Operation by Carotid Endarterectomy and Endovascular Angioplasty". World Neurosurg. 2019 Jan;121:287. doi: 10.1016/j.wneu.2018.09.033. No abstract available. — View Citation
Zanaty M, Samaniego EA, Teferi N, Kung DK, Nakagawa D, Hudson J, Ortega-Gutierrez S, Allan L, Jabbour P, Hasan DM. Hybrid Surgery for Internal Carotid Artery Revascularization. World Neurosurg. 2019 Jan;121:137-144. doi: 10.1016/j.wneu.2018.09.230. Epub 2018 Oct 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MTT | Resolution/improvement of increased mean transit time (MTT) on CT perfusion. RABID software will be analyzed using a T-Test, at enrollment vs. 1 year | 12-month | |
Other | Size of amygdala | The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year | 6 and 12-month | |
Other | Size of hippocampus | The change in size of amygdala in the ipsilateral side of COICA (t-test) at enrollment vs. 1 year | 6 and 12-month | |
Other | Lactate | Concentration of Lactate on MRI spectroscopy in centrum semiovale in the ipsilateral side of COICA at enrollment vs 1 year. | 6 and 12-month | |
Primary | MoCA Score | Cognitive outcome assessed by the MontReal Cognitive Assessment score | 12-month | |
Primary | Composite Cognitive Score | This is one outcome that reflects the overall cognition. The composite cognitive score at 12-month follow-up is assessed by a composite z score based on average z score for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests. Scores from tests in the proposed neuropsychological battery will be converted to z-scores. This is the following battery:
Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test ; Benton Visual Retention Test (BVRT) ; Controlled Oral Word Association (COWA) Test; Boston Naming Test;Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest;Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS);Iowa Scales of Personality Change (ISPC). |
12-month | |
Secondary | Stroke | Incidence of ipsilateral stroke | 12-month | |
Secondary | Hemorrhage | Incidence of ipsilateral cerebral hemorrhage | 12-month | |
Secondary | Death | Rate death | 12-months |
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