Stroke Prevention in the Wisconsin Native American Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stroke Prevention in the Wisconsin Native American Population

Conditions
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Stroke, Atherosclerosis

Intervention / Treatment
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* Other: High Risk - intensive coaching
* Other: High Risk - standard care
* Other: Low Risk - control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Risk- intense coaching<br>age ≥ 55 with MORE than three of the following risk factors: History of TIA/Stroke History of Coronary Artery disease History of Hypertension and/or current elevated blood pressure History of Diabetes Current smoker BMI ≥30 | Other: High Risk - intensive coaching<br>* 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.<br>|
| Other: High Risk - standard care<br>age ≥ 55 with MORE than three of the following risk factors: History of TIA/Stroke History of Coronary Artery disease History of Hypertension and/or current elevated blood pressure History of Diabetes Current smoker BMI ≥30 | Other: High Risk - standard care<br>* The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.<br>|
| Other: Low risk - control<br>age ≥ 55 with LESS than three of the following risk factors: History of TIA/Stroke History of Coronary Artery disease History of Hypertension and/or current elevated blood pressure History of Diabetes Current smoker BMI ≥30 | Other: Low Risk - control<br>* Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incidence of Stroke or TIA | Number of incidences of stroke or TIA during the study | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure | Number of Participants with diastolic blood pressure < 90 mmHg | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressure | Number of Participants with systolic blood pressure < 140 mmHg | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Total Cholesterol | Number of Participants with total cholesterol < 200 mg/dL | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Low Density Lipoprotein Cholesterol (LDL-C) | Number of Participants with LDL-C < 100 mg/dL | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for High Density Lipoprotein Cholesterol (HDL-C) | Number of Participants with HDL-C > 60 mg/dL | baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Blood Sugar | Number of Participants with A1c < 7.5 | Baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI) | Number of Participants who improve BMI | Baseline and 2 years | 
| Change in Number of Participants that meet AHA Simple Rules for Smoking Status | Number of Participants who Smoke | baseline and 2 years | 
| Change in TabCAT Score | The Tablet-based Cognitive Assessment Tool will examine avorites (rote verbal learning and memory), match (processing speed), flanker (executive functions), and line orientation (visuospatial abilities). | baseline and 2 years | 
| Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score | Montreal Cognitive Assessment will assess vascular cognitive decline | baseline and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plaque Area | Measured via carotid ultrasound. | baseline and 2 years | 
| Change in pulsatility index in carotid arteries | Measured 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 | baseline and 2 years | 
| Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors | Measured via carotid ultrasound | baseline and 2 years | 
| Change in Circulating Dipeptidyl Peptidase (DPPIV) | DPPIV is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years. | Baseline and 2 years | 
| Change in Circulating Galectin3 (Gal-3) | Gal-3 is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years. | baseline and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Atherosclerosis, Native American, Risk factor modification, Proteonomics, Genomics