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

August 18, 2013
August 20, 2013
April 2008
April 2018   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01926691 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Predictors for Poststroke Outcomes: Tel Aviv Brain Acute Stroke Cohort Acute Stroke Cohort (TABASCO)
Predictors for Poststroke Outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) Study

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.

The primary aim of the TABASCO study is to identify predictors of post stroke cognitive decline. A particular focus will be on inflammatory and stress markers, as well as neuroimaging measures.

Eligibility

Participants are recruited from patients admitted to the Department of Emergency Medicine at the Tel-Aviv Sourasky Medical Center (TASMC) within 72 hours of their first-ever acute ischemic stroke or transient ischemic attack (TIA) symptoms onset.

Criteria

Inclusion Criteria:

  1. Age ≥ 50 years
  2. Israeli residents
  3. Acute stroke that occurred within the last 3 days as defined by:

    acute focal neurological deficit

  4. Written informed consent by patient prior to study participation
  5. Willingness to participate in follow-up

Exclusion Criteria:

patients presenting with a primary hemorrhagic stroke (intracerebral or subarachnoid)

  1. history of any preceding cerebral vascular event (excluding TIA)
  2. imminent death or unconscious state
  3. 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
  4. known malignant disease or other chronic disease with poor prognosis (predicted survival less than two-years)
  5. stroke resulting from trauma or invasive procedure
  6. patients with a prestroke history consistent with dementia
  7. severe aphasia.

Stroke diagnosis is verified by senior vascular neurologists and baseline demographic and clinical data are collected. Interviews are conducted by trained interviewers at baseline, 3, 6, 12 and 18 months, and yearly thereafter up to 10 years.

Assessments and data collection A senior vascular neurologist conducts a thorough physical examination and reviews the imaging data and medical records of potential participants to determine eligibility. Participants are asked to consent for all study examinations and a signed informed consent is obtained from patients who agree.

Information is collected for the evaluation of co morbidities at the time of recruitment and throughout the study.

All subjects are prospectively followed at three-, six-, 12 and 18 months from stroke onset and annually thereafter. Approximately three-months after stroke, consenting participants are visited at home by trained occupational therapists.

For subjects who died, the date of death is recorded along with its cause, based on information obtained from the family, medical records, death certificates and data from the government's official civil registry.

Sample size In an attempt to identify a 40% difference in post stroke cognitive decline, we have calculated the required sample size (Ben Assayag E et al,International Journal of Stroke,Vol 7, June 2012, 341-347).

We aim to recruit at least 1125 participants to allow for loss to follow-up, potential clustering effects, missing data and to provide sufficient numbers for multivariate modeling.

Investigators

Principal Investigators:

Natan Bornstein, Prof. Tel Aviv Sourasky Medical Center Amos Korczyn, Prof. Tel Aviv University Einor Ben Assayag, Phd Tel Aviv Sourasky Medical Center

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
10 Years
Retention:   Samples With DNA
Description:

whole blood, serum, white cells, saliva

Non-Probability Sample

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.

  • Stroke
  • Dementia
  • Cerebrovascular Disorders
  • Alzheimer's Disease
  • Brain Ischemia
Not Provided
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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
534
Not Provided
April 2018   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Israel
 
NCT01926691
TABASCO
Yes
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
Michal Roll PhD,MBA
  • Tel Aviv University
  • Hebrew University of Jerusalem
  • Technische Universität Dresden
  • University of New Mexico
  • Charite University, Berlin, Germany
Not Provided
Tel-Aviv Sourasky Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP