NCT04755959

Brief 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). 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

February 13, 2021

Last Update Submit

February 13, 2021

Conditions

Keywords

StrokeCerebrovascular event

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Three years

Study Arms (3)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 1985385BACKGROUND
  • Stroke 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.

    PMID: 2407959BACKGROUND
  • Staessen 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.

    PMID: 15126928BACKGROUND
  • Schueller 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.

    PMID: 32063574BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Naftali Stern, Professor

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Central Study Contacts

Sigal Shaklai, Doctor

CONTACT

Naftali Stern, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 16, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

February 16, 2021

Record last verified: 2021-02