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NeuroCognition After Carotid Recanalization (NIA-SCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219774
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
David Hasan, University of Iowa

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Cognition Disorder Stroke Occlusion Carotid Procedure: Endovascular intervention Drug: Maximal medical therapy Phase 1 Phase 2

Detailed Description:

Study Design:

This is a phase 2 randomized single-center open label clinical trial with randomization of 1:1 to either best medical management vs. best medical management and endovascular revascularization of COICA.

Screening, Enrolling, & Randomization:

All subjects who presents to our tertiary hospital with a diagnosis of COICA will undergo full evaluation including 1) documenting previous history of transient ischemic attack (TIA) and/or stroke; 2) cervical and brain CT angiography (CTA) to document complete occlusion; 3) CT perfusion (CTP) to assess for presence of penumbra evident by increased mean transient time (MTT) in the ipsilateral side of COICA; and 4)MontReal cognitive assessment (MoCA) score. If any subject is found to have complete occlusion of COICA, evident of abnormal/prolongation of MTT on CTP, previous history of TIA and or stroke, and MoCA <26 & ≥ 23, then further evaluation is obtained including: MRI spectroscopy to assess for presence/absence of lactate in the ipsilateral watershed area (centrum semiovale), and size of ipsilateral hippocampus and amygdala, additional cognitive testing battery, and digital subtraction angiography (DSA) to document adequately the type of COICA the subject have (type A-D).

If any subject does not have complete occlusion, or complete occlusion but no abnormalities on CTP and/or MoCA >26, then the subject is excluded and no further testing needed (see exclusion criteria).

If the subject meets all inclusion criteria, then a baseline of complete neurological testing, full demographics, CTA or MRA, CTP, MoCA, additional neurological testing, MRI spectroscopy and DSA are obtained and subject is randomized 1:1 to either best medical management or best medical management + endovascular balloon angioplasty and stenting. Follow up clinic visits are arranged at 3 and 12 months. Repeat testing of MoCA and additional cognitive testing battery are done at these clinical follow-up visits (3 and 12 months). MRI of the brain and DSA is performed at 1 year follow-up to assess brain bio-markers and revascularization respectively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : February 1, 2026

Arm Intervention/treatment
Experimental: Endovascular arm Procedure: Endovascular intervention
Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg

Active Comparator: Medical arm Drug: Maximal medical therapy
Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.




Primary Outcome Measures :
  1. MoCA Score [ Time Frame: 12-month ]
    Cognitive outcome assessed by the MontReal Cognitive Assessment score

  2. Composite Cognitive Score [ Time Frame: 12-month ]

    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).



Secondary Outcome Measures :
  1. Stroke [ Time Frame: 12-month ]
    Incidence of ipsilateral stroke

  2. Hemorrhage [ Time Frame: 12-month ]
    Incidence of ipsilateral cerebral hemorrhage

  3. Death [ Time Frame: 12-months ]
    Rate death


Other Outcome Measures:
  1. MTT [ Time Frame: 12-month ]
    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

  2. Size of amygdala [ Time Frame: 12-month ]
    The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year

  3. Size of hippocampus [ Time Frame: 12-month ]
    The change in size of amygdala in the ipsilateral side of COICA (t-test) at enrollment vs. 1 year

  4. Lactate [ Time Frame: 12-month ]
    Concentration of Lactate on MRI spectroscopy in centrum semiovale in the ipsilateral side of COICA at enrollment vs 1 year.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 TPP on CTP in the ipsilateral side of the occluded ICA specifically in the middle cerebral artery (MCA) territory when compared to the opposite unaffected hemisphere
  • All occlusion is due to atherosclerotic disease
  • MoCA < 26 but ≥23

Exclusion Criteria:

  • Non-atherosclerotic occlusive disease that may have caused the occlusion, including moyamoya, dissection, trauma or other causes
  • Tandem occlusion
  • No evidence of increased MTT and /or PTT on CT perfusion
  • Severe co-morbid diseases: end-stage renal disease, renal insufficiency, liver cirrhosis, chronic obstructive pulmonary disease (COPD) requiring home oxygen, terminal illness such as cancer, Parkinson disease or other neurodegenerative diseases, severe cognitive heart failure, seizures, debilitating stroke, modified Rankin scale (mRS) ≥3.
  • Short life expectancy due to cancer or other co-morbid diseases
  • Class D on COICA classification

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219774


Contacts
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Contact: Eleanor Ryan 319-467-5677 eleanor-ryan@uiowa.edu
Contact: David Hasan (319) 384-8669 david-hasan@uiowa.edu

Locations
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United States, Iowa
University of Iowa hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Eleanor Ryan    319-467-5677    eleanor-ryan@uiowa.edu   
Principal Investigator: David Hasan, MD         
Sponsors and Collaborators
David Hasan
Publications:

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Responsible Party: David Hasan, Principle investigator, Professor of neurosurgery, Cerebrovascular neurosurgeon, Department of Neurosurgery, University of Iowa hospital and clinics, University of Iowa
ClinicalTrials.gov Identifier: NCT04219774    
Other Study ID Numbers: UOI
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders