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NCT Number: NCT06615973

Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke

Background:

Stroke is the fifth leading cause of death in the United States. It is also a leading cause of disability. More than 70% of people who survive strokes have mental impairment or dementia. Medical factors, such as the severity of the stroke, affect whether a person will have mental impairment afterward. But social factors, such as education and ethnicity, seem to play a role as well. Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke.

Objective:

To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke.

Eligibility:

People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 (Natural History of Stroke Study).

Design:

Participants will have 1 study visit, by telephone. The call will last about 45 minutes. Participants will talk about their health since their stroke. They will answer questions about themselves. Topics will include:

* Their race * Education * Ethnicity * Employment * Marital status * Residence address * Recent health history * Medical insurance

They will have tests of their memory, attention, and language skills. They will repeat numbers and words forward and backward.

Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007. This data will include:

* The hospital that first saw the participant at the time of their stroke. * The type of imaging that was first used then. * The primary diagnosis at admission. * Other medical details.

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Key information

Conditions

Stroke Brain Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorder Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

NIH Clinical Center Office of Patient Recruitment (OPR)

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

Study Description:

Clinical health outcomes and the likelihood of post stroke cognitive impairment and dementia (PSCID) can greatly vary following stroke incidence. Thus, developing a better understanding of what characteristics might provide resilience and enrich post-stroke recovery is of utmost importance. The NINDS Natural History of Stroke study (01N0007) was designed with the intention to generate natural history data of participants with or at-risk for acute stroke, transient ischemic attack (TIA), and other disturbances of cerebrovascular circulation. Through use of participants enrolled in the Natural History of Stroke study within the past six years, we aim to characterize social determinants of health (SDOH) and present-day cognitive function in this cohort. Following the collection of these data, we will examine how the core volume of acute supratentorial infarcts relates to post-stroke function as measured by the NIHSS, and how this association is modified based upon SDOH features and independent of treatment.

Objectives:

  • To characterize SDOH and assess if such characteristics modify the relationship between MRI core infarct volume and post-stroke function (i.e., NIHSS) at baseline and/or discharge. Resilience will thus be assessed by evaluating how specified SDOH modify the correlation between MRI core infarct volume and NIHSS.
  • To assess present cognitive function and assess if SDOH modify the relationship between MRI core infarct volume and present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between infarct volume and present-day cognition.
  • To assess if SDOH modify the relationship between poststroke function (i.e. NIHSS) at baseline and/or discharge with present-day cognition. Resilience will thus be assessed by evaluating how SDOH modify the correlation between NIHSS and present-day cognition.

Endpoints:

The primary purpose of this study is to assess SDOH and cognitive function in participants who have had a stroke in the past six years. To this end, the primary study outcomes will be post-stroke function as defined by NIHSS and present-day cognitive function.

  • Primary Endpoint: Association between MRI core infarct volume and post-stroke function (i.e. NIHSS) as modified by SDOH.
  • Secondary Endpoints: Association between MRI core infarct volume and present-day cognitive function as modified by SDOH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Adults aged 18 or older.
  • Previous participant in the Natural History of Stroke with an interpretable baseline MRI scan, NIHSS measured at baseline or discharge, and admission diagnosis of ischemic stroke.
  • Fluent in English or Spanish

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this

study:

-Modified Rankin Scale (mRS) = 6 at any follow-up (usually up to 90 days) in the Natural History of Stroke study (mRS = 6 indicates the participant is dead).

Treatment and study plan

Primary outcomes

  1. Post-stroke function as defined by NIH Stroke Scale (NIHSS)

    Time frame: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present

    Will use linear regression models to assess association between core infarct volume and post stroke function (as defined by NIHSS) as modified by SDOH

Secondary outcomes

  1. Present-day cognitive function

    Time frame: SDOH and present-day cognitive function gathered over phone (present "visit"), other data (including core infarct volume) gathered at time of Natural History of Stroke enrollment

    Will use linear regression models to assess association between core infarct volume and present-day cognition as modified by SDOH

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca F Gottesman, M.D.

CONTACT

[email protected]

(301) 435-9321

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Registry information

Official study title

Understanding Stroke Outcomes: Stroke Resilience, Infarct Burden, and Long-Term Cognition

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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