Predictors for Poststroke Outcomes: Tel Aviv Brain Acute Stroke Cohort Acute Stroke Cohort (TABASCO)

NCT01926691 | Completed DMC

• 1 other identifier: TABASCO
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Recent studies have demonstrated that even mild stroke survivors experience residual damage, which persists and in fact increases in subsequent years. About 45% of stroke victims remain with different levels of disability. While studies on cognitive impairment and dementia after stroke are receiving increasing clinical attention, the underlying pathophysiology is poorly understood. Identifying the mechanisms involved and recognizing early biomarkers for individual vulnerability, require a multi-modal approach, as the mechanisms involved in cerebrovascular disease and individual trajectories of post-stroke recovery may impact upon each other on various levels. Aims and Hypothesis: To date there is no single measure that can be used to identify patients who are prone to develop cognitive impairment and other disabilities from those with better recovery prospects. We hypothesize that data based on biochemical, neuroimaging, genetic and psychological measures can, in aggregate, serve as better predictors for subsequent disability, cognitive and neurological deterioration, and suggest possible interventions. Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study, a prospective cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate stroke patients. It is designed to evaluate the association between predefined demographic, psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events (including recurrent strokes), falls, affective changes, functional everyday difficulties and mortality. Discussion: This study is an attempt to comprehensively investigate the long term outcome of mild-moderate strokes. Its prospective design will provide quantitative data on stroke recurrence, the incidence of other vascular events and the evaluation of cognitive, affective and functional decline. Identifying the factors associated with post stroke cognitive and functional decline could potentially yield more effective therapeutic approaches. The investigators believe that an extensive approach of analyzing the interaction between different risk factors would more accurately predict neurological and cognitive deterioration.

Conditions

Stroke; Dementia; Cerebrovascular Disorders; Alzheimer's Disease; Brain Ischemia

Keywords

dementia; poststroke cognitive impairment; inflammation; stress

Outcome Measures

Primary Outcomes (1)

• dementia/cognitive decline occurrence

  This evaluation will be based on a neurological and general clinical examination, as well as an interview with the patient's family, by a cognitive neurologist, and a senior clinician to determine whether the participant meets the DSM IV criteria for dementia or is defined as minimal cognitive impairment (MCI).

  10 years

Secondary Outcomes (1)

• dementia or cognitive decline occurrence

  6 months - 10 years

Other Outcomes (1)

• Death or recurrent vascular events occurence

  Study entry - 10 years

Study Arms (1)

Acute First-ever Stroke

Patients over 50 years and without pre-stroke dementia, displaying an ischemic first-ever stroke or transient ischemic attack (TIA), onset within the last 72 hours, Israeli residents.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Department of Emergency Medicine at the Tel-Aviv Sourasky Medical Center (TASMC) within three-days of their first-ever acute ischemic stroke or transient ischemic attack (TIA) symptoms onset.

You may qualify if:

• Age ≥ 50 years
• Israeli residents
• Acute stroke that occurred within the last 3 days as defined by:
• acute focal neurological deficit, with a total score on the NIH Stroke Scale (NIHSS) \<17
• Written informed consent by patient prior to study participation
• Willingness to participate in follow-up

You may not qualify if:

• patients presenting with a primary hemorrhagic stroke (intracerebral or subarachnoid)
• history of any preceding cerebral vascular event (excluding TIA)
• imminent death or unconscious state
• patients unlikely to be released from hospital following the qualifying stroke, or have a severe disability after the
• qualifying stroke which makes follow-up unlikely
• known malignant disease or other chronic disease with poor prognosis (predicted survival less than two-years)
• stroke resulting from trauma or invasive procedure
• patients with a prestroke history consistent with dementia, or cognitive impairment before the stroke
• severe aphasia.

Sponsors & Collaborators

• Eli Sprecher, MD: lead
• Tel Aviv University: collaborator
• Hebrew University of Jerusalem: collaborator
• Technische Universität Dresden: collaborator
• University of New Mexico: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (5)

• Ben Assayag E, Korczyn AD, Giladi N, Goldbourt U, Berliner AS, Shenhar-Tsarfaty S, Kliper E, Hallevi H, Shopin L, Hendler T, Baashat DB, Aizenstein O, Soreq H, Katz N, Solomon Z, Mike A, Usher S, Hausdorff JM, Auriel E, Shapira I, Bornstein NM. Predictors for poststroke outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) study protocol. Int J Stroke. 2012 Jun;7(4):341-7. doi: 10.1111/j.1747-4949.2011.00652.x. Epub 2011 Nov 2.

  PMID: 22044517 BACKGROUND

• Seyman EE, Sadeh-Gonik U, Berman P, Blum I, Shendler G, Nathan B, Rothschild O, Molad J, Ben Assayag E, Hallevi H; TABASCO prospective cohort study group. Association between intracranial vessel calcifications, structural brain damage, and cognitive impairment after minor strokes: a prospective study. Front Neurol. 2023 Jul 18;14:1218077. doi: 10.3389/fneur.2023.1218077. eCollection 2023.

  PMID: 37533476 DERIVED

• Ben Assayag E, Eldor R, Korczyn AD, Kliper E, Shenhar-Tsarfaty S, Tene O, Molad J, Shapira I, Berliner S, Volfson V, Shopin L, Strauss Y, Hallevi H, Bornstein NM, Auriel E. Type 2 Diabetes Mellitus and Impaired Renal Function Are Associated With Brain Alterations and Poststroke Cognitive Decline. Stroke. 2017 Sep;48(9):2368-2374. doi: 10.1161/STROKEAHA.117.017709. Epub 2017 Aug 11.

  PMID: 28801477 DERIVED

• Tene O, Shenhar-Tsarfaty S, Korczyn AD, Kliper E, Hallevi H, Shopin L, Auriel E, Mike A, Bornstein NM, Assayag EB. Depressive symptoms following stroke and transient ischemic attack: is it time for a more intensive treatment approach? results from the TABASCO cohort study. J Clin Psychiatry. 2016 May;77(5):673-80. doi: 10.4088/JCP.14m09759.

  PMID: 27035632 DERIVED

• Ben Assayag E, Shenhar-Tsarfaty S, Korczyn AD, Kliper E, Hallevi H, Shopin L, Auriel E, Giladi N, Mike A, Halevy A, Weiss A, Mirelman A, Bornstein NM, Hausdorff JM. Gait measures as predictors of poststroke cognitive function: evidence from the TABASCO study. Stroke. 2015 Apr;46(4):1077-83. doi: 10.1161/STROKEAHA.114.007346. Epub 2015 Feb 12.

  PMID: 25677599 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, saliva

MeSH Terms

Conditions

Stroke; Dementia; Cerebrovascular Disorders; Alzheimer Disease; Brain Ischemia; Inflammation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research and Development

Study Record Dates

• First Submitted: August 18, 2013
• First Posted: August 21, 2013
• Study Start: April 1, 2008
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

IL (1)