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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborators:
Tel Aviv University
Hebrew University of Jerusalem
Technische Universität Dresden
University of New Mexico
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01926691
First received: August 18, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 is an ongoing, 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.

We believe that an extensive approach of analyzing the interaction between different risk factors would more accurately predict neurological deterioration.


Condition
Stroke
Dementia
Cerebrovascular Disorders
Alzheimer's Disease
Brain Ischemia

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • dementia/cognitive decline occurrence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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:
  • dementia or cognitive decline occurrence [ Time Frame: 6 months - 10 years ] [ Designated as safety issue: No ]
    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:
  • Death or recurrent vascular events occurence [ Time Frame: Study entry - 10 years ] [ Designated as safety issue: No ]
    Death or recurrent vascular events that occured after the first acute stroke.


Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells, saliva


Estimated Enrollment: 534
Study Start Date: April 2008
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Age ≥ 50 years
  • Israeli residents
  • Acute stroke that occurred within the last 3 days as defined by:
  • acute focal neurological deficit
  • 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
  • severe aphasia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926691

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Einor Ben Assayag, PhD    +972-3-6973414    einorba@tlvmc.gov.il   
Contact: Natan Bornstein, Prof.    +972-3-6973159    natanb@tlvmc.gov.il   
Principal Investigator: Natan Bornstein, Prof.         
Principal Investigator: Einor Ben Assayag, PhD         
Sponsors and Collaborators
Michal Roll PhD,MBA
Tel Aviv University
Hebrew University of Jerusalem
Technische Universität Dresden
University of New Mexico
Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Michal Roll PhD,MBA, Director of Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01926691     History of Changes
Other Study ID Numbers: TABASCO
Study First Received: August 18, 2013
Last Updated: August 20, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
dementia
poststroke cognitive impairment
inflammation
stress

Additional relevant MeSH terms:
Cerebrovascular Disorders
Stroke
Cerebral Infarction
Alzheimer Disease
Dementia
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014