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

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ClinicalTrials.gov Identifier: NCT01926691
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : December 7, 2020
Tel Aviv University
Hebrew University of Jerusalem
Technische Universität Dresden
University of New Mexico
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center

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.

Condition or disease
Stroke Dementia Cerebrovascular Disorders Alzheimer's Disease Brain Ischemia

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Study Type : Observational [Patient Registry]
Actual Enrollment : 575 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Predictors for Poststroke Outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) Study
Actual Study Start Date : April 1, 2008
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

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.

Primary Outcome Measures :
  1. dementia/cognitive decline occurrence [ Time Frame: 10 years ]
    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).

Secondary Outcome Measures :
  1. dementia or cognitive decline occurrence [ Time Frame: 6 months - 10 years ]
    Dementia/ cognitive decline occurrence [ Time Frame: 6, 12, 18 months and annually up to 10 years] this evaluation will be based on a neurological and general clinical examination, same as for primary outcome.

Other Outcome Measures:
  1. Death or recurrent vascular events occurence [ Time Frame: Study entry - 10 years ]
    Death or recurrent vascular events that occured after the first acute stroke.

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT01926691

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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Eli Sprecher, MD
Tel Aviv University
Hebrew University of Jerusalem
Technische Universität Dresden
University of New Mexico
Charite University, Berlin, Germany
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Sprecher, MD, Director of Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01926691    
Other Study ID Numbers: TABASCO
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Keywords provided by Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center:
poststroke cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Cerebrovascular Disorders
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes