Clinical trial NCT04382963: Stroke Prevention in the Wisconsin Native American Population
Official title: Stroke Prevention in the Wisconsin Native American Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Atherosclerosis
Keywords: Stroke
Atherosclerosis
Native American
Risk factor modification
Proteonomics
Genomics
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Partnership Program
First posted: 2020-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Incidence of Stroke or TIA
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressure
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Total Cholesterol
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Blood Sugar
timeFrame: Baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI)
timeFrame: Baseline and 2 years
measure: Change in Number of Participants that meet AHA Simple Rules for Smoking Status
timeFrame: baseline and 2 years
measure: Change in TabCAT Score
timeFrame: baseline and 2 years
measure: Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score
timeFrame: baseline and 2 years
Secondary outcomes:
measure: Change in Plaque Area
timeFrame: baseline and 2 years
measure: Change in pulsatility index in carotid arteries
timeFrame: baseline and 2 years
measure: Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors
timeFrame: baseline and 2 years
measure: Change in Circulating Dipeptidyl Peptidase (DPPIV)
timeFrame: Baseline and 2 years
measure: Change in Circulating Galectin3 (Gal-3)
timeFrame: baseline and 2 years
Other outcomes:
measure: Change in Serum microRNA
timeFrame: baseline and 2 years
measure: Compliance Rates
timeFrame: 2 years
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Oneida
country: United States
facility: Oneida Comprehensive Health Division
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Dempsey, MD
role: PRINCIPAL_INVESTIGATOR
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