Stroke Prevention in the Wisconsin Native American Population

November 22, 2023 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Oneida, Wisconsin, United States, 54155
        • Recruiting
        • Oneida Comprehensive Health Division
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure
Time Frame: baseline and 2 years
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
Time Frame: baseline and 2 years
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
Time Frame: baseline and 2 years
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)
Time Frame: baseline and 2 years
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)
Time Frame: baseline and 2 years
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
Time Frame: Baseline and 2 years
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)
Time Frame: Baseline and 2 years
Number of Participants who improve BMI
Baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Smoking Status
Time Frame: baseline and 2 years
Number of Participants who Smoke
baseline and 2 years
Change in Incidence of Stroke or TIA
Time Frame: baseline and 2 years
Number of incidences of stroke or TIA during the study
baseline and 2 years
Change in TabCAT Score
Time Frame: 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).
baseline and 2 years
Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score
Time Frame: baseline and 2 years
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
Time Frame: baseline and 2 years
Measured via carotid ultrasound.
baseline and 2 years
Change in Circulating Dipeptidyl Peptidase (DPPIV)
Time Frame: 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.
Baseline and 2 years
Change in Circulating Galectin3 (Gal-3)
Time Frame: 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.
baseline and 2 years
Change in pulsatility index in carotid arteries
Time Frame: 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
baseline and 2 years
Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors
Time Frame: baseline and 2 years
Measured via carotid ultrasound
baseline and 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum microRNA
Time Frame: 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.
baseline and 2 years
Compliance Rates
Time Frame: 2 years
Number of people complying with study
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Wisconsin Partnership Program

Investigators

  • Principal Investigator: Robert Dempsey, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1550
  • A535700 (Other Identifier: UW Madison)
  • SMPH/NEURO SURG/NEURO SURG (Other Identifier: UW Madison)
  • Protocol Version 11/12/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Following transparency and reproducibility guidelines (NIH NOT-OD-15-103), the data resulting from this research proposal will be made publicly available. This will help ensure that other researchers are able to reproduce and/or extend our findings, and will enhance the scientific rigor of this proposal. Data will be made available for download to any individual or organization who requests data and abides by a data-sharing agreement that will be developed. This agreement will require that the data be used solely for research, that individuals or organizations secure the data using conventional electronic safeguards, and that once data analysis is complete, the data be destroyed. In general, data acquired in this study will be made available publicly after initial key manuscripts have been accepted for publication. Manuscripts will include relevant methodological details to allow for reproducibility by other researchers and the ability to extend or findings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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