Stroke Prevention in the Wisconsin Native American Population
- Conditions
- StrokeAtherosclerosis
- Interventions
- Other: High Risk - standard careOther: Low Risk - controlOther: High Risk - intensive coaching
- Registration Number
- NCT04382963
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Risk - standard care 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 Low risk - control 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 High Risk- intense coaching High Risk - intensive 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
- Primary Outcome Measures
Name Time Method 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 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 Blood Sugar Baseline and 2 years Number of Participants with A1c \< 7.5
Change in Number of Participants that meet AHA Simple Rules for Smoking Status baseline and 2 years Number of Participants who Smoke
Change in Incidence of Stroke or TIA baseline and 2 years Number of incidences of stroke or TIA during the study
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 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 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 Body Mass Index (BMI) Baseline and 2 years Number of Participants who improve BMI
Change in TabCAT Score baseline and 2 years 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).
Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score baseline and 2 years Montreal Cognitive Assessment will assess vascular cognitive decline
- Secondary Outcome Measures
Name Time Method Change in Plaque Area baseline and 2 years Measured via carotid ultrasound.
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.
Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors baseline and 2 years Measured via carotid ultrasound
Change in pulsatility index in carotid arteries baseline and 2 years 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
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.
Trial Locations
- Locations (2)
Oneida Comprehensive Health Division
🇺🇸Oneida, Wisconsin, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States