Stroke Prevention in the Wisconsin Native American Population
NCT ID: NCT04382963
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2021-04-14
2025-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
55 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wisconsin Partnership Program
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Dempsey, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin-Madison
Madison, Wisconsin, United States
Oneida Comprehensive Health Division
Oneida, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Wang X, Jackson DC, Varghese T, Mitchell CC, Hermann BP, Kliewer MA, Dempsey RJ. Correlation of cognitive function with ultrasound strain indices in carotid plaque. Ultrasound Med Biol. 2014 Jan;40(1):78-89. doi: 10.1016/j.ultrasmedbio.2013.08.001. Epub 2013 Oct 11.
Rocque BG, Jackson D, Varghese T, Hermann B, McCormick M, Kliewer M, Mitchell C, Dempsey RJ. Impaired cognitive function in patients with atherosclerotic carotid stenosis and correlation with ultrasound strain measurements. J Neurol Sci. 2012 Nov 15;322(1-2):20-4. doi: 10.1016/j.jns.2012.05.020. Epub 2012 Jun 1.
McCormick M, Varghese T, Wang X, Mitchell C, Kliewer MA, Dempsey RJ. Methods for robust in vivo strain estimation in the carotid artery. Phys Med Biol. 2012 Nov 21;57(22):7329-53. doi: 10.1088/0031-9155/57/22/7329. Epub 2012 Oct 18.
Dempsey RJ, Vemuganti R, Varghese T, Hermann BP. A review of carotid atherosclerosis and vascular cognitive decline: a new understanding of the keys to symptomology. Neurosurgery. 2010 Aug;67(2):484-93; discussion 493-4. doi: 10.1227/01.NEU.0000371730.11404.36.
Shi H, Varghese T, Dempsey RJ, Salamat MS, Zagzebski JA. Relationship between ultrasonic attenuation, size and axial strain parameters for ex vivo atherosclerotic carotid plaque. Ultrasound Med Biol. 2008 Oct;34(10):1666-77. doi: 10.1016/j.ultrasmedbio.2008.02.014. Epub 2008 May 19.
Wang X, Mitchell CC, Varghese T, Jackson DC, Rocque BG, Hermann BP, Dempsey RJ. Improved Correlation of Strain Indices with Cognitive Dysfunction with Inclusion of Adventitial Layer with Carotid Plaque. Ultrason Imaging. 2016 May;38(3):194-208. doi: 10.1177/0161734615589252. Epub 2015 May 28.
Meshram NH, Varghese T, Mitchell CC, Jackson DC, Wilbrand SM, Hermann BP, Dempsey RJ. Quantification of carotid artery plaque stability with multiple region of interest based ultrasound strain indices and relationship with cognition. Phys Med Biol. 2017 Jul 17;62(15):6341-6360. doi: 10.1088/1361-6560/aa781f.
Barnett PA, Spence JD, Manuck SB, Jennings JR. Psychological stress and the progression of carotid artery disease. J Hypertens. 1997 Jan;15(1):49-55. doi: 10.1097/00004872-199715010-00004.
Pavlovic-Hournac M, Delbauffe D. Protein metabolism in hypo- and hyperstimulated rat thyroid glands. II. Degradation of newly formed thyroidal proteins. Horm Metab Res. 1976 Jan;8(1):55-61. doi: 10.1055/s-0028-1093673.
Nicolaides AN, Kakkos SK, Kyriacou E, Griffin M, Sabetai M, Thomas DJ, Tegos T, Geroulakos G, Labropoulos N, Dore CJ, Morris TP, Naylor R, Abbott AL; Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) Study Group. Asymptomatic internal carotid artery stenosis and cerebrovascular risk stratification. J Vasc Surg. 2010 Dec;52(6):1486-1496.e1-5. doi: 10.1016/j.jvs.2010.07.021.
Sztajzel R, Momjian S, Momjian-Mayor I, Murith N, Djebaili K, Boissard G, Comelli M, Pizolatto G. Stratified gray-scale median analysis and color mapping of the carotid plaque: correlation with endarterectomy specimen histology of 28 patients. Stroke. 2005 Apr;36(4):741-5. doi: 10.1161/01.STR.0000157599.10026.ad. Epub 2005 Feb 10.
Mitchell CC, Korcarz CE, Tattersall MC, Gepner AD, Young RL, Post WS, Kaufman JD, McClelland RL, Stein JH. Carotid artery ultrasound texture, cardiovascular risk factors, and subclinical arterial disease: the Multi-Ethnic Study of Atherosclerosis (MESA). Br J Radiol. 2018 Apr;91(1084):20170637. doi: 10.1259/bjr.20170637. Epub 2018 Jan 31.
Welsh KA, Butters N, Mohs RC, Beekly D, Edland S, Fillenbaum G, Heyman A. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part V. A normative study of the neuropsychological battery. Neurology. 1994 Apr;44(4):609-14. doi: 10.1212/wnl.44.4.609.
Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.
Heyman A, Fillenbaum GG, Welsh-Bohmer KA, Gearing M, Mirra SS, Mohs RC, Peterson BL, Pieper CF. Cerebral infarcts in patients with autopsy-proven Alzheimer's disease: CERAD, part XVIII. Consortium to Establish a Registry for Alzheimer's Disease. Neurology. 1998 Jul;51(1):159-62. doi: 10.1212/wnl.51.1.159.
Welsh KA, Fillenbaum G, Wilkinson W, Heyman A, Mohs RC, Stern Y, Harrell L, Edland SD, Beekly D. Neuropsychological test performance in African-American and white patients with Alzheimer's disease. Neurology. 1995 Dec;45(12):2207-11. doi: 10.1212/wnl.45.12.2207.
Fillenbaum GG, Burchett BM, Unverzagt FW, Rexroth DF, Welsh-Bohmer K. Norms for CERAD constructional praxis recall. Clin Neuropsychol. 2011 Nov;25(8):1345-58. doi: 10.1080/13854046.2011.614962. Epub 2011 Oct 13.
Whyte SR, Cullum CM, Hynan LS, Lacritz LH, Rosenberg RN, Weiner MF. Performance of elderly Native Americans and Caucasians on the CERAD Neuropsychological Battery. Alzheimer Dis Assoc Disord. 2005 Apr-Jun;19(2):74-8. doi: 10.1097/01.wad.0000165508.67993.a3.
Ellis G, Rodger J, McAlpine C, Langhorne P. The impact of stroke nurse specialist input on risk factor modification: a randomised controlled trial. Age Ageing. 2005 Jul;34(4):389-92. doi: 10.1093/ageing/afi075. No abstract available.
Vemuganti R. All's well that transcribes well: non-coding RNAs and post-stroke brain damage. Neurochem Int. 2013 Nov;63(5):438-49. doi: 10.1016/j.neuint.2013.07.014. Epub 2013 Aug 15.
Vorlicek J, Mechl Z. [Nephrologic complications of oncologic therapy]. Cas Lek Cesk. 1985 Dec 13;124(50):1561-2. No abstract available. Czech.
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.
Related Links
Access external resources that provide additional context or updates about the study.
The Oneida Stroke Prevention Program
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A535700
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/NEURO SURG/NEURO SURG
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 11/12/2020
Identifier Type: OTHER
Identifier Source: secondary_id
2019-1550
Identifier Type: -
Identifier Source: org_study_id