Protocol Details
Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals with History of Stroke
This study is currently recruiting participants.
Summary
Number |
001861-N |
Sponsoring Institute |
National Institute of Neurological Disorders and Stroke (NINDS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children;
Fetuses |
Keywords |
Stroke;
Social Determinants of Health;
Cognition;
cerebrovascular health;
Magnetic Resonance Imaging (MRI);
vascular health |
Recruitment Keyword(s) |
None |
Condition(s) |
Stroke;
Brain Disease;
Vascular Diseases;
Cerebrovascular Disorder |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Neurological Disorders and 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.
Eligibility
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).
-Is pregnant per self-report
Citations:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jim(SqrRoot)(Copyright)nez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Erratum in: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Erratum in: Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530. PMID: 28122885; PMCID: PMC5408160.
Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S. Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet. 2007 Jan 27;369(9558):293-8. doi: 10.1016/S0140-6736(07)60151-2. PMID: 17258669; PMCID: PMC1859855.
Clark DG, Boan AD, Sims-Robinson C, Adams RJ, Amella EJ, Benitez A, Lackland DT, Ovbiagele B. Differential Impact of Index Stroke on Dementia Risk in African-Americans Compared to Whites. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2725-2730. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.048. Epub 2018 Aug 1. PMID: 30076114; PMCID: PMC7282732.
Douiri A, Rudd AG, Wolfe CD. Prevalence of poststroke cognitive impairment: South London Stroke Register 1995-2010. Stroke. 2013 Jan;44(1):138-45. doi: 10.1161/STROKEAHA.112.670844. Epub 2012 Nov 13. PMID: 23150656.
El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1. PMID: 37125534.
Contacts:
Clinical Trials Number:
NCT06615973