Stroke Prevention in the Wisconsin Native American Population

Stroke Clinical Trial

Official title:

Stroke Prevention in the Wisconsin Native American Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04382963
• Other study ID #: 2019-1550
• Secondary ID: A535700SMPH/NEUR
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Oneida Comprehensive Health Division	Oneida	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Wisconsin Partnership Program

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Serum microRNA	Levels of serum microRNA are associated with increased stroke risk. This will be measured via blood draw at baseline and 2 years.	baseline and 2 years
Other	Compliance Rates	Number of people complying with study	2 years
Primary	Change in Incidence of Stroke or TIA	Number of incidences of stroke or TIA during the study	baseline and 2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Number of Participants that meet AHA Simple Rules for Blood Sugar	Number of Participants with A1c < 7.5	Baseline and 2 years
Primary	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
Primary	Change in Number of Participants that meet AHA Simple Rules for Smoking Status	Number of Participants who Smoke	baseline and 2 years
Primary	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
Primary	Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score	Montreal Cognitive Assessment will assess vascular cognitive decline	baseline and 2 years
Secondary	Change in Plaque Area	Measured via carotid ultrasound.	baseline and 2 years
Secondary	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
Secondary	Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors	Measured via carotid ultrasound	baseline and 2 years
Secondary	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
Secondary	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

External Links

•   The Oneida Stroke Prevention Program