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| ID | Type | Description | Link |
|---|---|---|---|
| A535700 | Other Identifier | UW Madison | |
| SMPH/NEURO SURG/NEURO SURG | Other Identifier | UW Madison | |
| Protocol Version 11/12/2020 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Wisconsin Partnership Program | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk- intense coaching | Other | age ≥ 55 with MORE than three of the following risk factors:
|
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| High Risk - standard care | Other | age ≥ 55 with MORE than three of the following risk factors:
|
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| Low risk - control | Other | age ≥ 55 with LESS than three of the following risk factors:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Risk - intensive coaching | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incidence of Stroke or TIA | Number of incidences of stroke or TIA during the study | baseline and 2 years |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Number of Participants that meet AHA Simple Rules for Blood Sugar | Number of Participants with A1c < 7.5 | Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Area | Measured via carotid ultrasound. | baseline and 2 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Compliance Rates | Number of people complying with study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Dempsey, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States | ||
| Oneida Comprehensive Health Division |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26066955 | Background | Harris R, Nelson LA, Muller C, Buchwald D. Stroke in American Indians and Alaska Natives: A Systematic Review. Am J Public Health. 2015 Aug;105(8):e16-26. doi: 10.2105/AJPH.2015.302698. Epub 2015 Jun 11. | |
| 26448914 | Background | Berman SE, Wang X, Mitchell CC, Kundu B, Jackson DC, Wilbrand SM, Varghese T, Hermann BP, Rowley HA, Johnson SC, Dempsey RJ. The relationship between carotid artery plaque stability and white matter ischemic injury. Neuroimage Clin. 2015 Aug 22;9:216-22. doi: 10.1016/j.nicl.2015.08.011. eCollection 2015. |
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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.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| High Risk - standard care | Other | 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 | Other | Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors. |
|
| 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 |
| Change in Number of Participants that meet AHA Simple Rules for Smoking Status | Number of Participants who Smoke | baseline and 2 years |
| 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 |
| Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score | Montreal Cognitive Assessment will assess vascular cognitive decline | baseline and 2 years |
| baseline and 2 years |
| Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors | Measured via carotid ultrasound | baseline and 2 years |
| 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 |
| 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 |
| 2 years |
| Oneida |
| Wisconsin |
| 54155 |
| United States |
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| 27525674 | Background | Wesley UV, Hatcher JF, Ayvaci ER, Klemp A, Dempsey RJ. Regulation of Dipeptidyl Peptidase IV in the Post-stroke Rat Brain and In Vitro Ischemia: Implications for Chemokine-Mediated Neural Progenitor Cell Migration and Angiogenesis. Mol Neurobiol. 2017 Sep;54(7):4973-4985. doi: 10.1007/s12035-016-0039-4. Epub 2016 Aug 15. |
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| 41778537 | Derived | Mitchell CC, Wilbrand SM, Hess T, Riesenberg A, Danforth D, Wesley UV, Schwartz ES, Varghese T, Blohowiak CJ, Vandenberg C, Metoxen MF, Lane K, Dempsey RJ. Cerebrovascular Risk Factors for Body Mass Index, Diabetes, and Atherosclerosis in a Wisconsin Native American Population: A Cross-Sectional Observation Study. J Am Heart Assoc. 2026 Mar 17;15(6):e043224. doi: 10.1161/JAHA.125.043224. Epub 2026 Mar 4. |
| 38295773 | Derived | Cress HJ, Mitchell CC, Wilbrand SM, Wesley UV, Morel Valdes GM, Hess T, Varghese T, Maybock J, Metoxen M, Riesenberg A, Vandenberg C, Blohowiak CJ, Kennard J, Danforth D, Dempsey RJ. Methods in Stroke Prevention in the Wisconsin Native American Population. Neuroepidemiology. 2024;58(4):300-309. doi: 10.1159/000536426. Epub 2024 Jan 31. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |