The following lists are in order from year 2018 in which the ancillary studies/collaborations were approved. Click on the “year” to jump to the lists of approved ancillary studies/collaborations in that year.
Ancillary Studies/Collaborations in Order of Year Approved
   
influencing influenza immunization response in American Indians - The SHS FLU
Project. PIs: Dr. Lyle Best (Missouri Breaks Industries Research, Inc.) and Dr.
Esther Erdei (University of New Mexico). This ancillary study proposes to
enroll, vaccinate, and examine prospectively immune response characteristics
and vaccine efficacy both among T2DM cases and controls who are participants of
the Strong Heart Study and Strong Heart Family Study in Arizona and Dakota SHS
centers. SC approval date: 05/17/2019.
- Exposure to Metal-Mixtures and Coronary Heart Disease across Diverse Populations. PI: Dr. Yu Chen (New York University School of Medicine). This study proposes to investigate the role of metal-mixtures in incident CHD across diverse populations, specifically among participants of the Strong Heart Family Study (SHFS), Health Effects of Arsenic Longitudinal Study (HEALS), and Multi-Ethnic Study of Atherosclerosis (MESA). This stud will leverage the rich resources of these prospective cohorts to investigate the association of metals with CHD, whether the association can be modified by genetic factors, and possible underlying mechanisms using metabolomics. SHS SC approval date: 05/17/2019.
- Cognition After (OSA) Treatment in Native American People (CATNAP). PI: Dr. Dedra Buchwald. This study will combine observational epidemiology to generate population-based estimates of obstructive sleep apnea prevalence and its association with cognitive function; a randomized controlled trial will test a novel intervention for improving treatment adherence; and an economic analysis to inform the intervention’s sustainability. This proposed study will recruit American Indian participants (ages 55+) of the Strong Heart Family Study (n = 480) and the Cerebrovascular Disease and Its Consequences in American Indians Study (n = 125) living in South Dakota. SC approval date: 05/02/2019.
- “Cancer Incidence in the Strong Heart Study (SHS) and Strong Heart Family Study (SHFS)” proposal in response to PA-17-288 “Leveraging Population-based Cancer Registry Data to Study Health Disparities” (NCI/NIH R21). PI: Amanda Janitz, PhD, University of Oklahoma Health Sciences Center. This study proposes to obtain cancer incidence data for SHS/SHFS participants by linking cohort data to state cancer registries. The study will also examine obesity-related cancer incidence in general. Assuming adequate number of cases, the study will also specifically investigate colorectal cancer, including which anthropometric measures are most associated with risk of the obesity-related cancers. SHS SC approval date: 04/5/2019.
- Arsenic Metabolism, Menopause and Diabetes in the Strong Heart Study. PI: Matthew Gribble, PhD, Emory University. SHS SC approval date: 03/19/2019.
- Supplement to the National Consortium on Psychosocial Stress, Spirituality, and Health. PI: Alexandra Shields, PhD, Harvard Medical School / Massachusetts General Hospital. This proposal is for additional testing in the previously approved ancillary study of the Strong Heart Study (SHS). Participants for this ancillary study were recruited at the Dakota Center only. Specifically, this supplemental study proposes to conduct additional epigenome-wide DNA methylation analyses from a sub-sample of 260 participants who have already provided survey and DNA data for this ongoing SHS ancillary study. SHS SC approval date: 12/21/2018.
- Project 2 of the Columbia University Superfund Research Program Reducing Arsenic Exposure: Approaches and Heath Benefits and entitled Early-life Arsenic Exposure, Nutritional Status, and Adult Diabetes Risk in American Indians (Strong Heart Lifespan Arsenic (SHAL) Study). PI: Dr. Ana Navas-Acien (Columbia University). This project will link the parents from the original Strong Heart Study cohort with the children in the Strong Heart Family Study cohort in order to investigate the role of early life Arsenic exposure on diabetes outcomes. SC approval date: 12/5/2018.
- Understanding the Racial and Ethnic Disparities in Heart Failure: A Cross Cohort Collaboration. This study proposes to pool data from 11 large longitudinal cohort studies, including the Strong Heart Study, to examine health disparities in the incidence and prognosis of heart failure and its subtypes in the United States. PI: Charles B Eaton, MD MS (Brown University). SHS SC approval date: 9/25/2018.
- Head Trauma, Cerebrovascular Disease, and Alzheimer's Dementia in the Strong Heart Study. This study will examine head trauma in relation to cerebrovascular and Alzheimer’s disease, including both structural changes to the brain and the cognitive sequelae, in American Indians from the Strong Heart Stroke Study (SHSS). This is an ancillary study using SHSS data and samples. All analyses will use stored data and specimens. PI: Dr. Dedra Buchwald (Washington State University). SHS SC approval date: 9/20/2018.
- Assessment of Metal Exposure in the Strong Heart Study (SHS) Cohort and Association with Morbidity and Mortality. PI: Dr. Zheng Li, (Centers for Disease Control and Prevention). This proposed sub-study will be conducted on the SHS original cohort participants using archived blood samples and existing surveillance data. The main goals of the study are to assess blood levels of five metals (lead, manganese, mercury, cadmium, and selenium) in the SHS original cohort and study the potential association between these exposures and cardiovascular disease and other adverse health outcomes. SHS SC approval date: 8/29/2018.
- Genetic Determinants and Epigenetic Mediators of Arsenic-Related Diabetes Incidence and Pathophysiology in the Strong Heart Study. PI: Dr. Matthew Gribble (Emory Univ Rollins School of Public Health). The goal of this proposed sub-study is to analyze existing data from the Strong Heart Study (and Strong Heart Family Study) to better understand the relationship between arsenic exposure and metabolism (measured at Phase I), DNA methylation (measured at Phase I), and diabetes (measured through Phase V). SHS SC approval date: 6/1/2018.
- Assessment of mercury (Hg) and other metals in biospecimens from the Strong Heart Family Study (SHFS). PI: Dr. Ana Navas-Acien. The proposed study will measure total Hg in blood and urine samples from a random-stratified sample of 150 participants in the SHFS. The proposed study will also measure arsenic, manganese, lead, cadmium, and selenium in blood samples and nickel in urine samples to characterize additional toxic metal exposures in the Strong Heart Study (SHS) population that have not been evaluated. Data resulting from this pilot study will be used as preliminary data in future R01 grants to evaluate Hg exposure and its health consequences in the SHS and SHFS cohorts. SHS SC approval date: 6/1/2018.
- Complete Cohort Ascertainment for Cerebrovascular Disease and its Consequences in American Indians. PI: Dr. Dedra Buchwald. This proposed ancillary study will enroll additional surviving participants of the Cerebrovascular Disease and its Consequences in American Indians study, augmenting ongoing data collection efforts using cognitive function examination and structural MRI protocols. SC approval date: 5/25/2018.
- Electrophysiological Substrate of Sudden Cardiac Arrest. Larisa G. Tereshchenko, MD, PhD (Oregon Health and Science University, Knight Cardiovascular Institute). This proposed study will use the Strong Heart Study resource and its existing data (resting 12-lead ECG and longitudinal event ascertainment) to study mechanisms of sudden cardiac arrest (SCA) explained by global electrical heterogeneity (GEH), considering sex and racial/ethnic differences in a multi-ethnic population, and to develop and validate a dynamic risk score of SCA. SHS SC approval date: 5/18/2018.
- Models for correlated time-to-event outcomes collected from large extended families and atherosclerotic cardiovascular disease risk prediction for American Indians: The Strong Heart Family Study. Wenyu Wang, PhD (OUHSC). Project proposes to develop new models for assessing association and risk prediction of a disease, such as atherosclerotic cardiovascular disease, defined as nonfatal myocardial infarction, CHD death, or fatal/nonfatal stroke, with its risk factors based on collected event/disease-free times and data from large extended families in the Strong Heart Family Study. SHS SC approval date: 5/3/2018.
- Screening for silent Afib in AIs using smartphone-based technology. PIs: Drs. Stavros Stavrakis and Julie Stoner (University of Oklahoma Health Sciences Center). SC approval date: 4/3/2018.
- The objective of this proposal is to delineate the risk of arterial thrombotic events after intracerebral hemorrhage, begin to elucidate potential mechanisms, and set the stage for randomized trials to identify optimal antithrombotic strategies. The study approach will be to analyze individual subject data pooled from the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, the Northern Manhattan Study (NOMAS), and the Strong Heart Study (SHS). Santosh Murthy (Cornell). SHS SC approval date: 5/31/2017.
- Development of a Bayesian prediction model and its subsequent application to the Strong Heart Family Study for the prediction of coronary heart disease and stroke. Yan Daniel Zhao, PhD (OUHSC Stephenson Cancer Center). SHS SC approval date: 10/16/2017.
- Cardiovascular Risk and American Indian Sleep Health Study. PI: Lonnie Nelson (Washington State University). This proposed study will assess the relationship between Native culture and sleep health in the context of cardiovascular disease (CVD) risk. In particular, it proposes a dual approach of 1) conducting one of the largest epidemiologic studies of sleep in AIs to assess the population prevalence of sleep deficiencies and their association with CVD risk and 2) applying community-based participatory methods to elicit local cultural perspectives on healthy sleep to develop patient-reported outcome measures (PROM) of sleep health and quality among AIs. SC approval date: 9/21/2017.
- Epigenetic predictors of cardiovascular disease risk in American Indians. Melanie Carless, PhD (Texas Biomedical Research Institute). This proposed research will assess the effect of differential epigenetic modifications, specifically DNA methylation signatures, on development of cardiovascular disease (CVD) and CVD mortality. In addition to assessing the direct effects on CVD, the proposal would contribute additional data to the SHS regarding heritable factors that mediate familial CVD risk. SHS SC approval date: 04/11/2017.
- Longitudinal Study of MRI, Clinical, and Genetic Biomarkers of Cognitive Impairment and Alzheimer's Disease in Elderly American Indians. Dr. Dedra Buchwald (Washington State Univesity). This study is one of the multidisciplinary studies integrated into the “American Indian and Alaska Native Health Disparities” lead by Dr. Spero Manson (Colorado School of Public Health). This project is a secondary data analysis of the existing Strong Heart Stroke Study, augmented by new measurements on existing MRIs relevant to cognitive impairment and Alzheimer’s Disease. This study also proposes to use the ApoE genotype data which has been previously assayed in an earlier phase of the Strong Heart Study. SHS SC approval date: 04-11-2017.
- Phenome-wide Association of Protein Function-altering Variants in a Family Study. Nora Franceschini, MD MPH, University of North Carolina. SHS SC approval date: 02/17/2017.
- Principal Component Pursuit to Assess Exposure to Mixtures in Environmental Epidemiologic Studies. Marianthi-Anna Kioumourtzoglou, ScD, Department of Environmental Health Sciences at Columbia University Mailman School of Public Health. SHS SC approval date: 02/09/2017.
- Dietary zinc and metallothionein as moderators of cadmium-associated cardiovascular disease risk. Ruixue Hou, PhD Student, Department of Nutrition at UNC-Chapel Hill and Nutrition Research Institute. SHS SC approval date: 01/24/2017.
- Low-moderate Arsenic Exposure and Respiratory Health in American Indian Communities. Martha Powers, MPH. Dept. of Environmental Health Sciences, Johns Hopkins School of Public Health. SHS SC approval date: 11/29/2016.
- Health Effects and Geochemistry of Arsenic NIEHS Superfund Research Program. Dr. Maria Tellez-Plaza, Institute for Biomedical Research Hospital Clinic of Valencia, Spain. The knowledge generated by this proposal will characterize metal-induced cardiovascular risk that is related to epigenetic modifications and can be transmitted to future generations. SHS SC approval date: 10/11/2016.
- Risk Factors for Subclinical Cardiovascular Disease and Kidney Disease in American Indian Youth: the Strong Heart Family Study. Amber Fyfe-Johnson, ND, Washington State University. SHS SC approval date: 10/04/2016.
- This nested case-control investigation proposes to evaluate serum amyloid A as a risk-stratifying biomarker for progression of diabetic kidney disease in the Strong Heart Study. Dr. Brad Dieter, Providence Foundation Research Fellow, Providence Medical Research Center, Providence Health Care; Dr. Jeffrey Henderson, Black Hills Center for American Indian Health. SHS SC approval date: 9/27/2016.
- Arsenic metabolism and metabolic syndrome in the Strong Heart Study. Miranda J Spratlen and Ana Navas-Acien (Johns Hopkins School of Public Health). Proposes to evaluate the interplay between arsenic exposure and arsenic metabolism with one carbon metabolism nutrients and the metabolic syndrome. SHS SC approval date: 4/5/2016.
- Health Effects of Arsenic Longitudinal Study. Project 1 of Superfund Hazardous Substance Research and Training Program. Habibul Ahsan (University of Chicago), Ana Navas-Acien (Columbia University). Proposes to pool data together from existent cohorts with arsenic and CVD data around the world (5-7 cohorts in total). Individual level meta-analysis 2-stage approach will be used. The 2 stage means that the associations are evaluated within each cohort first and then pooled across studies. The studies do not need to share data as each of them can run the models on their own and just share the statistical output for the 2nd stage pooling. SHS SC approval date: 3/23/2016.
- Nutritional Influences on Blood Arsenic, Arsenic Methylation & Cognitive Function in Children. Project 2 of Superfund Hazardous Substance Research and Training Program. Mary Gamble, Ana Navas-Acien (Columbia University). Proposes to evaluate the relationship between intake of one carbon metabolism nutrients and arsenic metabolism in adolescents 14 to 18 years of age. SHS SC approval date: 3/23/2016.
- Age-period-cohort analyses of cardiovascular disease and risk factors in American Indians: the Strong Heart Study and Strong Heart Family Study. PI: Clemma Muller (Washington State University). The overarching goals of this proposal are to evaluate birth cohort trends in cardiovascular disease (CVD), three chronic disease risk factors (diabetes, hypertension, and dyslipidemia), and three biomarkers (fasting glucose, blood pressure, and blood lipids) among participants of the SHS and Strong Heart Family Study (SHFS). These analyses will evaluate trends among participants who were born from 1910-1960, and will therefore relate to people who were young adults before and during the diabetes epidemic that emerged among American Indians in the second half of the 20th Century. SHS SC approval date: 2/8/2016.
- Functional assessment of uric acid transporter variants. R01 Renewal. Dr. Saroja Voruganti (Univ. North Carolina). Proposal will identify genetic variants that have an impact on levels of serum uric acid (SUA) and should provide valuable information on the altered mechanisms that lead to hyperuricemia and their association with CVD. SHS SC approval date: 11/9/2015.
- A Platform for Large-scale Discovery in Common Disease. Richard K. Wilson, PhD (University of Washington). Proposed investigation will identify risk and protective alleles influencing quantitative factors underlying CVD and metabolic risk in the Strong Heart Family Study. SHS SC approval date: 3/27/2015.
- The role of religiosity and spirituality in human health. PI: Alexandra Shields, Harvard School of Public Health. Whether Religiosity and Spirituality measures are significant predictors of methylation levels in stress-related genes, and of risk of mortality and chronic conditions, such as hypertension. A total of 1,200 SHS participants (400 from SHS DK center) will be included in this study. Participants would have to complete a 4-page questionnaire. SHS SC approval date: 3/3/2015.
- Epoxyeicosatrienoic acids, Diabetes and Cardiovascular Disease. Rozenn Lemaitre (University of Washington). Proposed research will be carried out in the Strong Heart Family Study. SHS SC approval date: 1/9/2015.
- Metabolic Syndrome, Obesity, and Diabetes Development in Relation to Phthalate Exposure in American Indians. Ellen Schur (University of Washington). A research project under the proposed Native Investigations for Environmental Health Solutions Center. SHS SC approval date: 1/9/2015.
- Air Pollution, Cardiopulmonary Health and Diabetes in American Indian Communities. Kristen Koehler (Johns Hopkins University). A research project under the proposed Native Investigations for Environmental Health Solutions Center. SHS SC approval date: 1/9/2015.
- Native Investigations for Environmental Health Solutions Center. Ana Navas-Acien (Johns Hopkins University) and Dedra Buchwald (University of Washington). This proposal includes 2 Research Projects (Project 1: Air Pollution, Cardiopulmonary Health and Diabetes in American Indian Communities; Project 2: Metabolic Syndrome, Obesity, and Diabetes Development in Relation to Phthalate Exposure in American Indians), the Pilot Project program, and the Community Engagement and Dissemination Core. The overarching goal of the Native Investigations for Environmental Health Solutions Center is to conduct basic and applied research that contributes to the recognition, documentation, remediation, and ultimately, prevention of environmental health disparities in underserved American Indian and Alaska Native populations. SHS SC approval date: 1/9/2015.
- Impact of obesity and metabolic dysregulation on MRI-quantified hepatic steatosis, stiffness, and altered cardiac tissue properties among American Indian participants in the Strong Heart Family Study. The SHS investigators. This proposal is designed to investigate prevalence, determinants, and cardiovascular associations of hepatic steatosis and fibrosis among American Indian participants in the Strong Heart Study. SHS SC approval date: 12/02/2014.
- Persistent organic pollutants and hyperuricemia in American Indian families. Dr. Saroja Voruganti (UNC). The overall goal of this project is to measure persistent organic pollutants and assess their relationship with hyperuricemia and CVD risk in American Indians of the Strong Heart Family Study. SHS SC approval date: 12/16/2014.
- Fatty Liver Disease and its Determinants in an American Indian Population: the Strong Heart Study. PI: Dr. Shelley Cole (Texas Biomedical Research Foundation). This study will use advanced magnetic resonance imaging (MRI) of the liver to non-invasively assess hepatic steatosis by MRI-derived proton density fat fraction (MRI-PDFF) and hepatic fibrosis by MR elastography-derived stiffness (MRE-stiffness) in a population-based sample of AI participants of the SHS. The goal is to identify cross-sectional associations and longitudinal determinants of hepatic steatosis and fibrosis in AI from the SHS. SHS SC approval date: 10/21/2014.
- Perceptions, Availability, and Use of Flavored Electronic Nicotine Delivery Systems among Urban and Rural American Indians. Dr. Dedra Buchwald, PI. This project will study the impact of flavored novel and conventional nicotine and tobacco products among American Indian (AI) youth and adults. This proposal will provide one year of funding for supplemental data collection for the funded project “Innovative Multigenerational Household Intervention to Reduce Stroke and CVD”, which will test the “Family Intervention in the Spirit of Motivational Interviewing (FITSMI)” intervention in AI Strong Heart Family Study households. SHS SC approval date: 09/23/2014.
- Leveraging ancestral diversity to map ventricular conduction loci in Hispanics. Proposes to characterize the genetics of ventricular action potential in Hispanic/Latino (HL) populations, and replicate findings in the American Indian participants of the Strong Heart Family Study (SHFS) and Strong Heart Study (SHS). Christy Avery (University of North Carolina), Shelley Cole (Texas Biomedical Research Foundation), Dr. Kari North (University of North Carolina). SHS SC approval date: 09/11/2014.
- Whole Genome Sequencing Project. Shelley Cole (Texas Biomedical Research Foundation). Identify and genotype essentially all genome wide variants by performing whole genome sequencing (WGS) of Strong Heart Family Study (SHFS) participants. Perform analyses to identify potentially functional variants for preclinical, CVD-related traits. Perform replication and participate in consortium analyses. SHS SC approval date: 07/29/2014.
- Urinary arsenic in relation to neurocognitive function. Clint Carroll, Ph.D. (Univ. of Minnesota). Measure urinary arsenic levels in a subset of 183 Strong Heart Study(SHS)/Strong Heart Stroke Study (SHSS) participants at two time points: Phase 1/Phase 3 (1998-99) and SHSS (2009-2013) examinations in order to estimate the association between urinary arsenic and neuropsychological outcomes. SHS SC approval date: 07/29/2014.
- Arsenic Exposure, Diabetes and Atherosclerosis. Jonathan Newman (NYU). Examining potential mechanisms linking chronic, low-level arsenic exposure to cardiovascular disease in the Strong Heart Study participants. SHS SC approval date: 06/27/2014.
- Renewal of R01 application entitled “Telomere Attrition and Diabetes Risk in American Indians”. Dr. Jinying Zhao, Tulane University. SHS SC approval date: 06/20/2014.
- Plasma phospholipid levels and their association with risk of incident diabetes and chronic kidney disease. Rozenn Lemaitre (UW), David Siscovic (UW), Mandy Fretts (UW). This investigation will measure phospholipid fatty acids in existing baseline plasma samples from 3665 SHFS participants from 93 families. Initial submission: Feb. 2013. SHS SC approval date for resubmission: 06/11/2014.
- Pre-eclampsia (PE) Among DK SHS Women. Dr. Lyle Best, PI DK SHS. This study proposes to contact those women in the DK SHS who said they had PE in SHS V to request permission to review their medical records to confirm the PE diagnosis. A sample of saliva will be collected to allow further DNA testing. The study also proposes another initiative to approach a group of DK SHS women who have had normal pregnancies and ask them for similar permission. Review of medical records and collection of saliva samples will be done by the staff that will be hired through the minority supplement award. SHS SC approval date: 05/30/2014.
- Metabolic Predictors of Diabetes (T2DM) in American Indians. Dr. Jinying Zhao, PI, Tulane University. The metabolite concentrations will be measured in fasting plasma of SHS participants in Phase 4 & 5 followed through Phase 6. Additionally, the study proposes to use fasting plasma samples collected at Phase 2 followed to Phase 3 for replication in consideration of the incident T2DM events and statistical power. SHS SC approval date: 05/23/2014.
- Alzheimer’s Disease Satellite Core. Dedra Buchwald (UW) in collaboration with Alzheimer’s Disease Research Center (UW). Follow-up approximately 120 OK SHSS participants to repeat most of the measures that were done in SHSS (including MRI), and to expand the neurocognitive battery to include components of the Uniform Data Set (UDS) in 35 of the 120 participants. SHS SC approval date: 03/26/2014.
- Novel integration of genes, toxic metals and hypertension. Examine the association of urinary cadmium (Cd), with blood pressure (systolic, diastolic and mean arterial pressure) and hypertension; Examine the joint main and interactive effects between genetic variants in genes related to toxic metal uptake and detoxification, and GWAS blood pressure genes on Cd and blood pressure and hypertension. Nora Franceschini (UNC). SHS SC approval date: 02/18/2014.
- Rhythm and Timing Exercises for Cerebrovascular Disease in American Indians. Steven Verney (Univ. of New Mexico). This proposal is about using rhythm and timing exercises at home to improve mental and physical functioning in American Indians who are at high risk for stroke. SHS SC approval date: 01/29/2014.
- Pilot Study of the Association between Phthalate Exposure and Cardiovascular Health Outcomes in an American Indian Population. Ellen Schur (Univ. of Washington). Measurement of urinary phthalate metabolites from existing samples collected during the SHS. SHS SC approval date: 01/21/2014.
- Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities. Ana Navas-Acien (Johns Hopkins). Intervention proposal involving DK SHS communities. SHS SC approval date: 01/21/2014.
- SHS to join the CKD Prognosis Consortium (web link: http://www.jhsph.edu/research/centers-and-institutes/chronic-kidney-disease-prognosis-consortium/). SHS SC approval date: 01/07/2014