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Stroke Prevention in the Wisconsin Native American Population

Stroke Prevention in the Wisconsin Native American Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04382963
Enrollment
120
Registered
2020-05-11
Start date
2021-04-14
Completion date
2025-10-01
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Stroke

Keywords

Stroke, Atherosclerosis, Native American, Risk factor modification, Proteonomics, Genomics

Brief summary

This project will develop a Stroke Awareness Team including training of Oneida Health Service Coaches working in partnership with the UW team for a population-based health awareness program. This team will develop a series of Oneida Nation Healthy Living and Stroke Awareness Events (from now on health events) to provide education as to the severity of the problem as well as our standard therapies for lifestyle change and risk factor avoidance. This will include education of the healthy members of the tribe including the children to identify signs of stroke and TIA in their elders as well as to develop healthy lifestyles at the earliest of ages to influence the elders to modify their risks.

Detailed description

The study will enroll 100 high risk tribe members and 20 low stroke risk tribe members. Each of these will be further studied for their atherosclerotic load by ultrasound measurements at the carotid bifurcation for presence of plaque as well as its stability or instability during pulsation. Enrolled participants will also receive assessment of biomarkers for stroke risk, including stroke-related vascular cognitive decline, an early and modifiable marker of TIA risk and serum analysis for glucose, cholesterol, microRNA and key proteins felt to be biomarkers of stroke. The high risk participants will be randomized into two groups, and data analyzed by gender, age, history of cerebrovascular events, and the presence or absence of atherosclerosis in their carotid bifurcation including equal numbers of participants that in spite of high risk, have not yet deposited plaque. * One group will receive advice about standard therapy and information concerning risk factor guidelines to improve health awareness. * The other group will receive the same plus intensive initiation of the American Heart Association Guidelines for Management of Risk Factors with at least quarterly individual face-to-face coaching meetings on lifestyle change and adherence to treatment. At the end of 2-year follow-up, all groups will be reassessed for adherence to the program, atherosclerotic plaque progression or regression and its stability, serum biomarker response to therapy interventions, successful risk factor modification, vascular cognitive decline and incidence of stroke and TIA. Intention to treat analysis will estimate the efficacy of health coaching and will use G-estimation to correct for issues of non-compliance and discontinuation. Groups will be compared for change in both risk factors and outcomes. Vascular cognitive decline is an important symptom of cerebrovascular disease which may precede a physical stroke with devastating results. Extensive preliminary data show that the frequency of this is surprisingly common in high risk patients and may predispose patients to later dementia. Vascular cognitive decline is a risk factor for stroke, but also is modifiable. A prior small study showed that intervention could stop the rate of decline. The study will see if this predicts participants at greatest risk for stroke that would improve with an intensive intervention program.

Interventions

OTHERHigh Risk - intensive coaching

The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education, intensive coaching face-to-face. Furthermore, this group will receive intensive initiation of the American Heart Association Guidelines for Management of Risk Factors with individual face-to-face coaching meetings on lifestyle change and adherence to treatment on at a least quarterly basis.

OTHERHigh Risk - standard care

The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.

OTHERLow Risk - control

Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.

Sponsors

Wisconsin Partnership Program
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants receiving health care through the Oneida Health Council Program * Participants deemed to be at high risk for stroke by modified Framingham assessment of medical history, including cerebral cardiovascular symptomatology, hypertension, diabetes, smoking, BMI * Willingness to participate in the study, including two-year follow-up * Controls will be selected using the same criteria with the exception that upon screening, they are not deemed to be at high risk for stroke.

Exclusion criteria

* Presence of established dementia * Inability to participate in physical and exercise programs due to preexisting disability * Illiteracy * Prior carotid procedure altering ultrasound finding * Presence of medical condition precluding participation or follow-up over a two-year period of time.

Design outcomes

Primary

MeasureTime frameDescription
Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First scorebaseline and 2 yearsMontreal Cognitive Assessment will assess vascular cognitive decline
Change in Number of Participants that meet AHA Simple Rules for Total Cholesterolbaseline and 2 yearsNumber of Participants with total cholesterol \< 200 mg/dL
Change in Number of Participants that meet AHA Simple Rules for Low Density Lipoprotein Cholesterol (LDL-C)baseline and 2 yearsNumber of Participants with LDL-C \< 100 mg/dL
Change in Number of Participants that meet AHA Simple Rules for High Density Lipoprotein Cholesterol (HDL-C)baseline and 2 yearsNumber of Participants with HDL-C \> 60 mg/dL
Change in Number of Participants that meet AHA Simple Rules for Blood SugarBaseline and 2 yearsNumber of Participants with A1c \< 7.5
Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI)Baseline and 2 yearsNumber of Participants who improve BMI
Change in Number of Participants that meet AHA Simple Rules for Smoking Statusbaseline and 2 yearsNumber of Participants who Smoke
Change in TabCAT Scorebaseline and 2 yearsThe Tablet-based Cognitive Assessment Tool will examine avorites (rote verbal learning and memory), match (processing speed), flanker (executive functions), and line orientation (visuospatial abilities).
Change in Incidence of Stroke or TIAbaseline and 2 yearsNumber of incidences of stroke or TIA during the study
Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressurebaseline and 2 yearsNumber of Participants with diastolic blood pressure \< 90 mmHg
Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressurebaseline and 2 yearsNumber of Participants with systolic blood pressure \< 140 mmHg

Secondary

MeasureTime frameDescription
Change in Circulating Galectin3 (Gal-3)baseline and 2 yearsGal-3 is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.
Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factorsbaseline and 2 yearsMeasured via carotid ultrasound
Change in Circulating Dipeptidyl Peptidase (DPPIV)Baseline and 2 yearsDPPIV is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.
Change in pulsatility index in carotid arteriesbaseline and 2 yearsMeasured via carotid ultrasound. This index is a unitless measurement calculated: peak systolic velocity - end diastolic velocity, divided by the mean velocity, higher values are thought to represent increased resistance to blood flow
Change in Plaque Areabaseline and 2 yearsMeasured via carotid ultrasound.

Other

MeasureTime frameDescription
Compliance Rates2 yearsNumber of people complying with study
Change in Serum microRNAbaseline and 2 yearsLevels of serum microRNA are associated with increased stroke risk. This will be measured via blood draw at baseline and 2 years.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026