StrokeTABASCONCT01926691
Predictors for Poststroke Outcomes: Tel Aviv Brain Acute Stroke Cohort Acute Stroke Cohort (TABASCO)
An observational study of Stroke and Dementia, run by Eli Sprecher, MD at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Dementia, Cerebrovascular Disorders
- How many people
- 575 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2008to 31 Dec 2015
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- stroke resulting from trauma or invasive procedure
- patients with a prestroke history consistent with dementia, or cognitive impairment before the stroke
- severe aphasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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:
- Age ≥ 50 years
- Israeli residents
- Acute stroke/TIA 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 previous 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.
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 24 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 24 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).
The investigators 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
- Conditions
- Stroke, Dementia, Cerebrovascular Disorders, Alzheimer's Disease, Brain Ischemia
- Keywords
- dementia, poststroke cognitive impairment, inflammation, stress
- Medical subject headings
- Stroke, Dementia, Cerebrovascular Disorders, Alzheimer Disease, Brain Ischemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
Secondary outcomes (1)
dementia or cognitive decline occurrence
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.
Measured: 6 months - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study start1 Apr 2008
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Eli Sprecher, MD
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University, Hebrew University of Jerusalem, Technische Universität Dresden, University of New Mexico, Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926691
- Sponsor's protocol ID
- TABASCO
- Acronym
- TABASCO
- Status last verified
- Dec 2020
- First submitted
- 18 Aug 2013
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22044517Seyman 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.
PubMed 37533476Ben 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.
PubMed 28801477Tene 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.
PubMed 27035632Ben 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.
PubMed 25677599
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Poststroke Outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) Study
- ClinicalTrials.gov ID
- NCT01926691
- Acronym / sponsor ID
- TABASCO / TABASCO
- Conditions
- Stroke, Dementia, Cerebrovascular Disorders, Alzheimer's Disease, Brain Ischemia
- Keywords
- dementia, poststroke cognitive impairment, inflammation, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Eli Sprecher, MDOther government
- Collaborators
- Tel Aviv University, Hebrew University of Jerusalem, Technische Universität Dresden, University of New Mexico, Charite University, Berlin, Germany
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Age ≥ 50 years
- Israeli residents
- Acute stroke/TIA 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 previous 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.
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 24 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 24 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).
The investigators 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
dementia or cognitive decline occurrence
Time frame: 6 months - 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Background: PubMed 22044517Ben 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.
- Derived from this study: PubMed 37533476Seyman 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.
- Derived from this study: PubMed 28801477Ben 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.
- Derived from this study: PubMed 27035632Tene 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.
- Derived from this study: PubMed 25677599Ben 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Dementia, run by Eli Sprecher, MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dementia/cognitive decline occurrence (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926691, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.