Stroke Prevention in the Wisconsin Native American Population

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Recruiting

CT.gov ID

NCT04382963

Collaborator

Wisconsin Partnership Program (Other)

120

Enrollment

Locations

Arms

34.5

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Atherosclerosis	Other: High Risk - intensive coaching Other: High Risk - standard care Other: Low Risk - control	N/A

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 divided into two groups, stratified 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Stroke Prevention in the Wisconsin Native American Population

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: High Risk- intense coaching 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 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.
Other: High Risk - standard care 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 The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.
Other: Low risk - control 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 Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.

Arm

Intervention/Treatment

Other: High Risk- intense coaching

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

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.

Other: High Risk - standard care

Other: High 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.

Other: Low risk - control

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

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

Outcome Measures

Primary Outcome Measures

Change in Incidence of Stroke or TIA [baseline and 2 years]
Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure [baseline and 2 years]
Number of Participants with diastolic blood pressure < 90 mmHg
Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressure [baseline and 2 years]
Number of Participants with systolic blood pressure < 140 mmHg
Change in Number of Participants that meet AHA Simple Rules for Total Cholesterol [baseline and 2 years]
Number 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 years]
Number 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 years]
Number of Participants with HDL-C > 60 mg/dL
Change in Number of Participants that meet AHA Simple Rules for Blood Sugar [Baseline and 2 years]
Number of Participants with A1c < 7.5
Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI) [Baseline and 2 years]
Number of Participants who improve BMI
Change in Number of Participants that meet AHA Simple Rules for Smoking Status [baseline and 2 years]
Number of Participants who Smoke
Change in CERAD-NAB Score [baseline and 2 years]
The Consortium to Establish a Registry for Alzheimer's disease-Neuropsychological Assessment Battery (CERAD-NAB) is a cognitive assessment of episodic memory by asking the participant to recall 10 unrelated words before and after a 5-10 minute delay. Scores are from 0 to 10 depending on the words recalled. Interpretation of scoring is encoded relative to education and age.

Secondary Outcome Measures

Change in Plaque Area [baseline and 2 years]
Measured via carotid ultrasound.
Change in Pulsatile Strain in Arterial Plaque [baseline and 2 years]
Measured via carotid ultrasound.
Change in Grayscale Median (GSM) Values [baseline and 2 years]
Measured via carotid ultrasound. [Is this a measure of size?]
Change in Circulating Dipeptidyl Peptidase (DPPIV) [Baseline and 2 years]
DPPIV is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.
Change in Circulating Galectin3 (Gal-3) [baseline and 2 years]
Gal-3 is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.

Other Outcome Measures

Change in Serum microRNA [baseline and 2 years]
Levels of serum microRNA are associated with increased stroke risk. This will be measured via blood draw at baseline and 2 years.
Compliance Rates [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.