NCT04382963|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · UW Madison
OTHER · UW Madison
OTHER · UW Madison
interventional
120
1 country
2
Study Start
April 14, 2021
Actual (reported)Primary Completion
October 1, 2025
Actual (reported)Study Completion
October 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2020
Actual (reported)May 11, 2020
Actual (reported)April 14, 2021
Actual (reported)October 1, 2025
Actual (reported)October 1, 2025
Actual (reported)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 Plaque Area
baseline and 2 years
Change in pulsatility index in carotid arteries
baseline and 2 years
Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors
baseline and 2 years
Change in Circulating Dipeptidyl Peptidase (DPPIV)
Baseline and 2 years
Change in Circulating Galectin3 (Gal-3)
baseline and 2 years
Change in Serum microRNA
baseline and 2 years
Compliance Rates
2 years
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
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
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.
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Oneida Comprehensive Health Division
Oneida, Wisconsin, 54155, United States
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.
Robert Dempsey, MD
University of Wisconsin, Madison
120 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
April 14, 2021
Actual (reported)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
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
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
The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.
Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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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.
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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.
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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.
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.
Primary Completion
October 1, 2025
Actual (reported)Study Completion
October 1, 2025
Actual (reported)Last Updated
December 18, 2025
Record last verified: 2025-05
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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Source: ClinicalTrials.gov.
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