StrokeNCT04755959
Stroke Prediction Through Internet Search Queries
An observational study of Stroke and Acute Myocardial Infarction, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Cerebrovascular disease (stroke) is a leading cause of mortality and disability. Common risk assessment tools for stroke are based on the Framingham equation, which relies on traditional cardiovascular risk factors (e.g., hypertension, dyslipidemia, diabetes, smoking, atrial fibrillation). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute Myocardial Infarction
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Dec 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All individuals 65 years old or older at diagnosis, that were discharged from the Tel-Aviv Sourasky Medical Center with a diagnosis of stroke supported by imaging or a diagnosis of acute myocardial infraction, or unaffected spouses or volunteers complying to age criteria.
Who may be able to join
- One of the following clauses a, b or c:
- Discharge from the Tel Aviv-Sourasky Med Center with an imaging study- supported diagnosis of stroke at any date starting 6/2016 to 03/2020.
- Discharge from the Tel Aviv-Sourasky Med Center with a clinical diagnosis of acute myocardial infarction supported by biochemical, electrocardiographic and/or imaging study, at any date starting 6/2016 to 03/2020.
- Spouse of patient in clause "a" or "b", provided that the spouse did not undergo a clinical stroke within the same timeframe or earlier.
- The use of internet on a regular basis prior to the event due to which the subject has been included in this study.
- Consent to allow the Tel-Aviv University Partner Team (Prof. Ran Gilad-Bachrach and authorized lab members) access to their Google queries from 2 years before to one year after the stroke event.
Who cannot join
- A diagnosis of TIA or stroke not supported by imaging studies
- Diagnosed prior cognitive impairment
- Diagnosed co-existing neurodegenerative diseases
- Diagnosed and not fully treated hormonal or nutritional deficiency, with the exception of post-menopausal state or male hypogonadism.
Trial locations and contacts
No sites are listed yet.
Naftali Stern, Professor contact
About this study
Official title: Stroke Prediction Study Using a Model Based on Internet Search Queries
Cerebrovascular disease (stroke) is a leading cause of mortality and disability. Common risk assessment tools for stroke are based on the Framingham equation, which relies on traditional cardiovascular risk factors (e.g., hypertension, dyslipidemia, diabetes, smoking, atrial fibrillation). These risk assessment tools calculate the likelihood for a general vascular "event" such as stroke and myocardial infarction in the near decade, but do not assess the risk for an impending event although that would enable taking immediate preventive action (e.g. anticoagulants for atrial fibrillation; control of hypertension). Covert cerebrovascular disease is linked to subtle cognitive and motor deficits and increased risk for stroke. We hypothesize that it is possible to identify subjects with impending stroke based on their internet communication features 0-12 months prior to the actual occurrence of acute clinical stroke. Based on this we have previously developed an internet-based algorithm that accurately identifies people at risk of stroke through cognitive changes manifested in their search queries. The purpose of this study is to validate the model and train a new model by analyzing Google queries of patients hospitalized in the Tel-Aviv Sourasky Medical Center with stroke. Acute myocardial infarction and unaffected spouses will serve as controls.
Read the detailed description
In this study we will analyze Google queries of patients hospitalized in the Tel-Aviv Sourasky Medical Center with stroke, between the years 2016-2020. following the formal completion of the signed informed consent form, consenting subjects will personally request their search data from Google Takeout service from up to 2 years before to one year after the stroke and provide access to the researchers by creating a one-time file of these data and sharing them with the researchers. Following an informed consent data of Google queries will extracted by the participants using google "Take Out" service, from up to 2 years before to one year after the stroke. The control groups will consist of patients diagnosed with acute myocardial infarction (MI) and MI/stroke -free patients' spouses. Recruitment will be primarily from two institutionally approved data bases of stroke and acute MI. A total of 450 participants will be recruited, 150 in each group, based on prior experience for the minimally-sized dataset of query logs needed to construct a model and test its performance.
Anonymity will be guaranteed through several modalities; access to the Google Takeout data will be limited to the minimal amount required to perform the research and will be given only to members of the data analysis team in the Tel-Aviv University, while access to the medical data will be provided only to researchers from the Tel-Aviv Sourasky Medical Center. Additionally, members of the Tel-Aviv University Partner Team will be obligated to refrain from any positive attempts to identify subjects participating in the trial. All data shared with Tel-Aviv University will be stored on a local, encrypted, hard disk. The data will be deleted from Tel-Aviv University's computers at the end of the project.
Our previously developed Machine Learning model, which was able to predict stroke in subjects as compared to age matched controls with an area under curve (AUC) of 0.972 which translates to a positive predictive value of 52.7% at a false-positive rate of 1%, will be used to predict, for each day, the likelihood that a person will undergo a stroke event on that day. This will be compared to the known date of stroke or MI. The measure of performance will be the Receiver Operating Curve (ROC) of the detection and the corresponding Area Under Curve (AUC). Additionally, a new model will be trained using the collected data and tested similarly, albeit using 10-fold cross-validation. Stroke detection sensitivity and specificity will be derived.
- Conditions
- Stroke, Acute Myocardial Infarction
- Keywords
- Stroke, Cerebrovascular event
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Stroke | Individuals hospitalized in the Tel-Aviv Sourasky Medical Center with a diagnosis of Ischemic Stroke, between the years 2016-2020 as documented in an institutionally approved data base of stroke, who will consent to provide access to their data from Google Take Out service. | |
| Acute myocardial infarction | Individuals hospitalized in the Tel-Aviv Sourasky Medical Center with a diagnosis of acute myocardial infarction as documented in an institutionally approved data base of myocardial infarction, who will consent to provide access to their data from Google Take Out service. | |
| Healthy controls | Unaffected spouses or volunteers who will consent to provide access to their data from Google Take Out service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of stroke detecion
The sensitivity of the algorithm to detect subjects who developed stroke, based on an internet query of their communications 0-12 months prior to the date of the stroke.
Measured: Three years
Specificity of stroke detection
The specificity of the detection rate, based on comparisons with the query profile in a concurrent cohort with acute myocardial infarction within the same time frame as well as with the stroke patients' stroke-free spouses.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Naftali Stern, Professor, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755959
- Sponsor's protocol ID
- 0361-20-TLV
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As this is not an interventional study, but rather retrospective, data sharing is not obligatory. Further, the study involves review and analysis of personal internet communications and participants are assured that this type of data remains entirely blinded to the investigators and a computer based strategy to that aim has been set. Nevertheless, specific requests fo data sharing may be directed to the authors after the completion of the study with the understanding that any such request, will be subject not only to the investigators' discretion but to specific approval by the Tel Aviv-Sourasky Medical Center's IRB (Helsinki Committee). Requests can be made after the completion of the trial and the publication of its outcome by the investigators in the form of a published article/s or reports.
Publications
Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
PubMed 1985385Stroke Prevention in Atrial Fibrillation Study Group Investigators. Preliminary report of the Stroke Prevention in Atrial Fibrillation Study. N Engl J Med. 1990 Mar 22;322(12):863-8. doi: 10.1056/NEJM199003223221232.
PubMed 2407959Staessen JA, Thijisq L, Fagard R, Celis H, Birkenhager WH, Bulpitt CJ, de Leeuw PW, Fletcher AE, Forette F, Leonetti G, McCormack P, Nachev C, O'Brien E, Rodicio JL, Rosenfeld J, Sarti C, Tuomilehto J, Webster J, Yodfat Y, Zanchetti A; Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Effects of immediate versus delayed antihypertensive therapy on outcome in the Systolic Hypertension in Europe Trial. J Hypertens. 2004 Apr;22(4):847-57. doi: 10.1097/00004872-200404000-00029.
PubMed 15126928Schueller SM, Steakley-Freeman DM, Mohr DC, Yom-Tov E. Understanding perceived barriers to treatment from web browsing behavior. J Affect Disord. 2020 Apr 15;267:63-66. doi: 10.1016/j.jad.2020.01.131. Epub 2020 Jan 23.
PubMed 32063574
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Prediction Study Using a Model Based on Internet Search Queries
- ClinicalTrials.gov ID
- NCT04755959
- Acronym / sponsor ID
- 0361-20-TLV
- Conditions
- Stroke, Acute Myocardial Infarction
- Keywords
- Stroke, Cerebrovascular event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Feb 2021 (actual)
- 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.
Cerebrovascular disease (stroke) is a leading cause of mortality and disability. Common risk assessment tools for stroke are based on the Framingham equation, which relies on traditional cardiovascular risk factors (e.g., hypertension, dyslipidemia, diabetes, smoking, atrial fibrillation). These risk assessment tools calculate the likelihood for a general vascular "event" such as stroke and myocardial infarction in the near decade, but do not assess the risk for an impending event although that would enable taking immediate preventive action (e.g. anticoagulants for atrial fibrillation; control of hypertension). Covert cerebrovascular disease is linked to subtle cognitive and motor deficits and increased risk for stroke. We hypothesize that it is possible to identify subjects with impending stroke based on their internet communication features 0-12 months prior to the actual occurrence of acute clinical stroke. Based on this we have previously developed an internet-based algorithm that accurately identifies people at risk of stroke through cognitive changes manifested in their search queries. The purpose of this study is to validate the model and train a new model by analyzing Google queries of patients hospitalized in the Tel-Aviv Sourasky Medical Center with stroke. Acute myocardial infarction and unaffected spouses will serve as controls.
Detailed description
In this study we will analyze Google queries of patients hospitalized in the Tel-Aviv Sourasky Medical Center with stroke, between the years 2016-2020. following the formal completion of the signed informed consent form, consenting subjects will personally request their search data from Google Takeout service from up to 2 years before to one year after the stroke and provide access to the researchers by creating a one-time file of these data and sharing them with the researchers. Following an informed consent data of Google queries will extracted by the participants using google "Take Out" service, from up to 2 years before to one year after the stroke. The control groups will consist of patients diagnosed with acute myocardial infarction (MI) and MI/stroke -free patients' spouses. Recruitment will be primarily from two institutionally approved data bases of stroke and acute MI. A total of 450 participants will be recruited, 150 in each group, based on prior experience for the minimally-sized dataset of query logs needed to construct a model and test its performance.
Anonymity will be guaranteed through several modalities; access to the Google Takeout data will be limited to the minimal amount required to perform the research and will be given only to members of the data analysis team in the Tel-Aviv University, while access to the medical data will be provided only to researchers from the Tel-Aviv Sourasky Medical Center. Additionally, members of the Tel-Aviv University Partner Team will be obligated to refrain from any positive attempts to identify subjects participating in the trial. All data shared with Tel-Aviv University will be stored on a local, encrypted, hard disk. The data will be deleted from Tel-Aviv University's computers at the end of the project.
Our previously developed Machine Learning model, which was able to predict stroke in subjects as compared to age matched controls with an area under curve (AUC) of 0.972 which translates to a positive predictive value of 52.7% at a false-positive rate of 1%, will be used to predict, for each day, the likelihood that a person will undergo a stroke event on that day. This will be compared to the known date of stroke or MI. The measure of performance will be the Receiver Operating Curve (ROC) of the detection and the corresponding Area Under Curve (AUC). Additionally, a new model will be trained using the collected data and tested similarly, albeit using 10-fold cross-validation. Stroke detection sensitivity and specificity will be derived.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Individuals hospitalized in the Tel-Aviv Sourasky Medical Center with a diagnosis of Ischemic Stroke, between the years 2016-2020 as documented in an institutionally approved data base of stroke, who will consent to provide access to their data from Google Take Out service. |
| Acute myocardial infarction | – | –Individuals hospitalized in the Tel-Aviv Sourasky Medical Center with a diagnosis of acute myocardial infarction as documented in an institutionally approved data base of myocardial infarction, who will consent to provide access to their data from Google Take Out service. |
| Healthy controls | – | –Unaffected spouses or volunteers who will consent to provide access to their data from Google Take Out service. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All individuals 65 years old or older at diagnosis, that were discharged from the Tel-Aviv Sourasky Medical Center with a diagnosis of stroke supported by imaging or a diagnosis of acute myocardial infraction, or unaffected spouses or volunteers complying to age criteria.
Key inclusion criteria (6 listed)
- One of the following clauses a, b or c:
- The use of internet on a regular basis prior to the event due to which the subject has been included in this study.
- Consent to allow the Tel-Aviv University Partner Team (Prof. Ran Gilad-Bachrach and authorized lab members) access to their Google queries from 2 years before to one year after the stroke event.
Key exclusion criteria (4 listed)
- A diagnosis of TIA or stroke not supported by imaging studies
- Diagnosed prior cognitive impairment
- Diagnosed co-existing neurodegenerative diseases
- Diagnosed and not fully treated hormonal or nutritional deficiency, with the exception of post-menopausal state or male hypogonadism.
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
Sensitivity of stroke detecion
Time frame: Three years
The sensitivity of the algorithm to detect subjects who developed stroke, based on an internet query of their communications 0-12 months prior to the date of the stroke.
Specificity of stroke detection
Time frame: Three years
The specificity of the detection rate, based on comparisons with the query profile in a concurrent cohort with acute myocardial infarction within the same time frame as well as with the stroke patients' stroke-free spouses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 1985385Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Background: PubMed 2407959Stroke Prevention in Atrial Fibrillation Study Group Investigators. Preliminary report of the Stroke Prevention in Atrial Fibrillation Study. N Engl J Med. 1990 Mar 22;322(12):863-8. doi: 10.1056/NEJM199003223221232.
- Background: PubMed 15126928Staessen JA, Thijisq L, Fagard R, Celis H, Birkenhager WH, Bulpitt CJ, de Leeuw PW, Fletcher AE, Forette F, Leonetti G, McCormack P, Nachev C, O'Brien E, Rodicio JL, Rosenfeld J, Sarti C, Tuomilehto J, Webster J, Yodfat Y, Zanchetti A; Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Effects of immediate versus delayed antihypertensive therapy on outcome in the Systolic Hypertension in Europe Trial. J Hypertens. 2004 Apr;22(4):847-57. doi: 10.1097/00004872-200404000-00029.
- Background: PubMed 32063574Schueller SM, Steakley-Freeman DM, Mohr DC, Yom-Tov E. Understanding perceived barriers to treatment from web browsing behavior. J Affect Disord. 2020 Apr 15;267:63-66. doi: 10.1016/j.jad.2020.01.131. Epub 2020 Jan 23.
- Individual participant dataSharing planned: Undecided. As this is not an interventional study, but rather retrospective, data sharing is not obligatory. Further, the study involves review and analysis of personal internet communications and participants are assured that this type of data remains entirely blinded to the investigators and a computer based strategy to that aim has been set. Nevertheless, specific requests fo data sharing may be directed to the authors after the completion of the study with the understanding that any such request, will be subject not only to the investigators' discretion but to specific approval by the Tel Aviv-Sourasky Medical Center's IRB (Helsinki Committee). Requests can be made after the completion of the trial and the publication of its outcome by the investigators in the form of a published article/s or reports.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Naftali Stern, Professor contact
Naftali Stern, Professor study director
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Acute Myocardial Infarction, run by Tel-Aviv Sourasky Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigal Shaklai, Doctor (+97236973732, sigalsh@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of stroke detecion (time frame: Three years). The study lists 2 primary outcomes in all. 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 NCT04755959, which also lists 4 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 16 Feb 2021.