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StrokeNCT04382963

Stroke Prevention in the Wisconsin Native American Population

A study testing High Risk - intensive coaching in people with Stroke and Atherosclerosis, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Atherosclerosis
What is being tested?
High Risk - intensive coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
14 Apr 2021to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Oneida Comprehensive Health Division

    Oneida, Wisconsin, 54155

Other trials in United States

About this study

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.

Read the 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.

Being tested
High Risk - intensive coaching, High Risk - standard care, Low Risk - control
Keywords
Stroke, Atherosclerosis, Native American, Risk factor modification, Proteonomics, Genomics
Medical subject headings
Stroke, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Risk - intensive coachingOther

    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 careOther

    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 - controlOther

    Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.

Study groups in NCT04382963
Study groupRoleWhat they receive
High Risk- intense coachingOtherage ≥ 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
Receives: Other: High Risk - intensive coaching
High Risk - standard careOtherage ≥ 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
Receives: Other: High Risk - standard care
Low risk - controlOtherage ≥ 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
Receives: Other: Low Risk - control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Incidence of Stroke or TIA

    Number of incidences of stroke or TIA during the study

    Measured: baseline and 2 years

  2. Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure

    Number of Participants with diastolic blood pressure < 90 mmHg

    Measured: baseline and 2 years

  3. Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressure

    Number of Participants with systolic blood pressure < 140 mmHg

    Measured: baseline and 2 years

  4. Change in Number of Participants that meet AHA Simple Rules for Total Cholesterol

    Number of Participants with total cholesterol < 200 mg/dL

    Measured: baseline and 2 years

  5. 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

    Measured: baseline and 2 years

  6. 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

    Measured: baseline and 2 years

  7. Change in Number of Participants that meet AHA Simple Rules for Blood Sugar

    Number of Participants with A1c < 7.5

    Measured: Baseline and 2 years

  8. Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI)

    Number of Participants who improve BMI

    Measured: Baseline and 2 years

  9. Change in Number of Participants that meet AHA Simple Rules for Smoking Status

    Number of Participants who Smoke

    Measured: baseline and 2 years

  10. 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).

    Measured: baseline and 2 years

  11. Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score

    Montreal Cognitive Assessment will assess vascular cognitive decline

    Measured: baseline and 2 years

Secondary outcomes (5)

  1. Change in Plaque Area

    Measured via carotid ultrasound.

    Measured: baseline and 2 years

  2. 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

    Measured: baseline and 2 years

  3. Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors

    Measured via carotid ultrasound

    Measured: baseline and 2 years

  4. 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.

    Measured: Baseline and 2 years

  5. 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.

    Measured: baseline and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start14 Apr 2021
  3. Primary completion1 Oct 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382963
Sponsor's protocol ID
2019-1550
Other IDs
A535700, SMPH/NEURO SURG/NEURO SURG, Protocol Version 11/12/2020
Status last verified
May 2025
First submitted
6 May 2020
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 26066955

  • 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.

    PubMed 26448914

  • Darwish MA, Hammon WM. Studies on Japanese B encephalitis virus vaccines from tissue culture. VI. Development of a hamster kidney tissue culture inactivated vaccine for man. 3. Potency testing of an attenuated strain of OCT-541. J Immunol. 1966 May;96(5):878-84. No abstract available.

    PubMed 4288023

  • 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.

    PubMed 27525674

  • Amersfoort J, Schaftenaar FH, Douna H, van Santbrink PJ, Kroner MJ, van Puijvelde GHM, Quax PHA, Kuiper J, Bot I. Lipocalin-2 contributes to experimental atherosclerosis in a stage-dependent manner. Atherosclerosis. 2018 Aug;275:214-224. doi: 10.1016/j.atherosclerosis.2018.06.015. Epub 2018 Jun 13.

    PubMed 29960897

  • Hochmeister S, Engel O, Adzemovic MZ, Pekar T, Kendlbacher P, Zeitelhofer M, Haindl M, Meisel A, Fazekas F, Seifert-Held T. Lipocalin-2 as an Infection-Related Biomarker to Predict Clinical Outcome in Ischemic Stroke. PLoS One. 2016 May 6;11(5):e0154797. doi: 10.1371/journal.pone.0154797. eCollection 2016.

    PubMed 27152948

  • Greenland S, Lanes S, Jara M. Estimating effects from randomized trials with discontinuations: the need for intent-to-treat design and G-estimation. Clin Trials. 2008;5(1):5-13. doi: 10.1177/1740774507087703.

    PubMed 18283074

  • Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.

    PubMed 12660385

  • Tyas SL, Salazar JC, Snowdon DA, Desrosiers MF, Riley KP, Mendiondo MS, Kryscio RJ. Transitions to mild cognitive impairments, dementia, and death: findings from the Nun Study. Am J Epidemiol. 2007 Jun 1;165(11):1231-8. doi: 10.1093/aje/kwm085. Epub 2007 Apr 12.

    PubMed 17431012

  • Mitchell CC, Stein JH, Cook TD, Salamat S, Wang X, Varghese T, Jackson DC, Sandoval Garcia C, Wilbrand SM, Dempsey RJ. Histopathologic Validation of Grayscale Carotid Plaque Characteristics Related to Plaque Vulnerability. Ultrasound Med Biol. 2017 Jan;43(1):129-137. doi: 10.1016/j.ultrasmedbio.2016.08.011. Epub 2016 Oct 5.

    PubMed 27720278

  • Jackson DC, Sandoval-Garcia C, Rocque BG, Wilbrand SM, Mitchell CC, Hermann BP, Dempsey RJ. Cognitive Deficits in Symptomatic and Asymptomatic Carotid Endarterectomy Surgical Candidates. Arch Clin Neuropsychol. 2016 Feb;31(1):1-7. doi: 10.1093/arclin/acv082. Epub 2015 Dec 10.

    PubMed 26663810

  • Dempsey RJ, Jackson DC, Wilbrand SM, Mitchell CC, Berman SE, Johnson SC, Meshram NH, Varghese T, Hermann BP. The Preservation of Cognition 1 Year After Carotid Endarterectomy in Patients With Prior Cognitive Decline. Neurosurgery. 2018 Mar 1;82(3):322-328. doi: 10.1093/neuros/nyx173.

    PubMed 28575478

  • Dempsey RJ, Varghese T, Jackson DC, Wang X, Meshram NH, Mitchell CC, Hermann BP, Johnson SC, Berman SE, Wilbrand SM. Carotid atherosclerotic plaque instability and cognition determined by ultrasound-measured plaque strain in asymptomatic patients with significant stenosis. J Neurosurg. 2018 Jan;128(1):111-119. doi: 10.3171/2016.10.JNS161299. Epub 2017 Mar 10.

    PubMed 28298048

  • Mitchell CC, Wilbrand SM, Kundu B, Steffel CN, Varghese T, Meshram NH, Li G, Cook TD, Salamat MS, Dempsey RJ. Transcranial Doppler and Microemboli Detection: Relationships to Symptomatic Status and Histopathology Findings. Ultrasound Med Biol. 2017 Sep;43(9):1861-1867. doi: 10.1016/j.ultrasmedbio.2017.04.025. Epub 2017 Jun 20.

    PubMed 28645797

  • Wang X, Jackson DC, Mitchell CC, Varghese T, Wilbrand SM, Rocque BG, Hermann BP, Dempsey RJ. Classification of Symptomatic and Asymptomatic Patients with and without Cognitive Decline Using Non-invasive Carotid Plaque Strain Indices as Biomarkers. Ultrasound Med Biol. 2016 Apr;42(4):909-18. doi: 10.1016/j.ultrasmedbio.2015.11.025. Epub 2016 Jan 5.

    PubMed 26778288

Questions about this trial

What is this clinical trial studying?

A study testing High Risk - intensive coaching in people with Stroke and Atherosclerosis, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Incidence of Stroke or TIA (time frame: baseline and 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04382963, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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