SABER Projects

BASIC: The Brain Attack Surveillance in Corpus Christi project

Principal Investigators: Lynda D. Lisabeth, PhD, MPH and Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
The Brain Attack Surveillance in Corpus Christi (BASIC) project is an ongoing stroke surveillance study that began in 1999. SABER began providing data management and programming services to support this study in 2014. BASIC is the only ongoing stroke surveillance project focusing on Mexican-Americans. Since the inception of this project, over 5,000 cerebrovascular disease patients have been followed.
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BASIC: Cognitive
Principal Investigator: Lewis B. Morgenstern, MD
Sponsor: NIH
This study uses door-to-door surveillance in Nueces County, Texas, a non-immigrant, bi-ethnic community, to determine the prevalence and trajectory over time of cognitive impairment and dementia in Mexican Americans and non Hispanic whites. The study will evaluate the roles of vascular disease risk factors, educational attainment and socio-economic status, community resources and caregiving roles to examine ethnic disparities. SABER provides data management and programming for this study.
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BASIC: Outcomes Among Surrogate Decision Makers In Stroke (OASIS)
Principal Investigators: Darin Zahuranec, MD and Lewis B. Morgenstern, MD
Sponsor: NIH
Often, people with stroke need help from another person to make decisions about important medical treatments. However, we know very little about the experience and outcomes of these family members who make medical decisions for a loved one with a stroke. This study aims to answer important questions about how doctors communicate with family decision makers during these difficult times, how people make decisions for stroke patients, and the long-term impact on those who serve as decision-makers for stroke patients. SABER provides data management and programming for this study. 
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BASIC: Sleep Studies
Principal Investigators: Devin L. Brown, MD, MS and Lynda D. Lisabeth, PhD, MPH
Sponsor: NIH
The University of Michigan Stroke Program investigates multiple aspects of post-stroke sleep apnea in patients in Corpus Christi, Texas. (1) An NHLBI-funded ancillary study assessed the frequency of sleep-disordered breathing after stroke, and the relationship of this sleep disorder to stroke outcomes. (2) The NINDS-funded sleep apnea study is designed to investigate health disparities related to sleep apnea in stroke patients. (3) An NHLBI-funded ancillary study investigates the association between nocturnal rostral fluid shifts and sleep apnea severity. (4) Finally, an NINDS-funded longitudinal, population-based study of sleep apnea and stroke outcomes is performed to improve the identification and management of important sleep apnea after stroke, provide critical data to plan future clinical trials, and explore a potential target to reduce an important ethnic health disparity. SABER provides data management and programming for these studies.
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CAPTURE: Validating a Unique COPD Case Finding Tool in Primary Care
Principal Investigators: Fernando Martinez, Weill-Cornell and Meilan Han, University of Michigan
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
CAPTURE is a large prospective study which explores the impact of the CAPTURE screening tool for COPD on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial. The study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE tool and have research spirometry testing. The tool will be compared against the spirometry testing. In addition, participating primary care practices will be randomized in a 1:1 fashion to receiving either a general COPD education module, or a COPD module that includes training on the use of the CAPTURE tool, to assess the 12-month impact on patient outcomes.
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ChiLDREN: The Childhood Liver Disease Research and Education Network 
Principal Investigator: John Magee, MD
Sponsor: National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
ChiLDREN is a network of 15 clinical sites conducting clinical trials and cohort studies of children with rare liver diseases. The ChiLDREN Network was developed to support the discovery of new diagnostics, etiologic, and treatment options for children with liver disease, and those who undergo liver transplantation. SABER partners to provide statistical analysis, clinical monitoring, project management, and clinical research administration to support this series of studies.
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Citalopram: Citalopram as a Posterior Cortical Protective Therapy in Parkinson’s Disease
Principal Investigator:Vikas Kotagal, MD, MS
Sponsor:National Institute of Aging (NIA)
Citalopram is a 5-year proof-of-concept Parkinson disease clinical trial aimed at delaying visuospatial cognitive decline, a critical component of Parkinson disease dementia. This is a single-site, phase 2, double-blind, and placebo-controlled study.  Participants with Parkinson disease will be enrolled in the study for 28-months, and will receive either 20mg of citalopram daily, or matching placebo.  They will undergo PET and MRI imaging, as well as cognitive and clinical testing.  SABER is the DCC for this project and will provide project management, data management, software development, and statistical analysis.
Study website coming soon...

DFC: Diabetic Foot Consortium
Principal Investigator: Cathie Spino, ScD
Sponsor: NIDDK
The Diabetic Foot Consortium (DFC) is a network of 6 clinical sites, several biomarker analysis units and the data coordinating center (DCC) that will conduct studies to validate biomarkers for diabetic foot ulcers. Future studies may expand to include clinical trials. SABER is the DCC for this consortium and provides the project management, data management, clinical monitoring, software development, and statistical analysis for this study. Presently, three observational studies are in development: c-myc (c-myc and phosphorylated glucocorticoid receptor), TEWL (Trans-epidermal Water Loss) and Biorepository.
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Doxycycline for Emphysema in People Living with HIV (DEPTH)
Study PIs: Robert Kaner, MD and Marshall Glesby, MD
Sponsor: NHLBI
DEPTH (Doxycycline for Emphysema in People Living with HIV) is a phase 2, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Based on randomization, participants will receive 100 mg doxycycline BID or placebo for 72-weeks. The primary objective is to determine if doxycycline reduces progression of emphysema relative to placebo as measured by rate of decline (slope) of present predicted diffusing capacity for carbon monoxide (DLco) corrected for hemoglobin, carboxyhemoglobin, and barometric pressure (indicated as ppDLcoadj) over the 72-week treatment period. SABER is the DCC for this project and will provide project management, data management, clinical monitoring, software development and statistical analysis for the clinical trial.

EGCG: Dose Ranging Study of Oral Epigallocatechin-3-Gallate (EGCG) Given Daily For 12 Weeks to Patients with Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions with Standard of Care Drugs, and Biomarkers of Drug Effect.
Principal Investigators: Harold A. Chapman, MD; Fernando J. Martinez, MD, MS; and Sydney Montesi, MD
Sponsor: UCSF
The EGCG study is a multi-center, double-blind, placebo-controlled, dose-ranging Phase 1 study looking at EGCG safety in Idiopathic Pulmonary Fibrosis (IPF) patients. This interventional study will test weather a low cost and largely non-toxic small molecule, purified from green tea, EGCG, is safe when given daily to IPF patients over 12 weeks with their IPF drugs, nintedanib and pirfenidone, and the PK interactions of EGCG with these standard of care anti-fibrotic drugs. SABER is the DCC for this project and will provide project management, data management, clinical monitoring, software development and statistical analysis for the clinical trial.
Study website coming soon…

EMERGE: Emergency Medicine Education and Research by Global Experts
Principal Investigator: Prashant Mahajan, MD MPH MBA
EMERGE is a pilot project to develop an international network of experts in emergency room departments to collaborate in research and share emergency medicine-related education. SABER is assisting this project by developing a combined dataset derived from electronic medical records from 10 countries (and counting) to describe the departments in each country, to answer research questions, and to create a platform for prospective research initiatives. As the project evolves from pilot stage, SABER will provide project management, software development, and statistical analysis support for its clinical research initiatives.
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Lipodystrophy Syndromes to Determine Prevalence, Incidence and Predictors of Diabetes and Severe Hypertriglyceridemia, and their Complications (LYNC-LD)
Study PI: Elif Oral, MD
Sponsor: Originally funded by Aegerion Pharmaceuticals. Now funded by Lipodystrophy Research Fund established at the University of Michigan.
LYNC-LD is a prospective multicenter natural history study of Lipodystrophy Syndromes to Determine Prevalence, Incidence and Predictors of Diabetes and Severe Hypertriglyceridemia, and their Complications. This is an international, multicenter,  prospective registry study of patients with lipodystrophies to define true prevalence estimates and document a thorough snapshot of the natural history of lipodystrophies in the contemporary era. Approximately 500 participants will be enrolled with all forms of lipodystrophy syndromes. Their participation will last approximately 4 years while we collect robust clinical, metabolic, morbidity, and mortality data. The primary aim is to determine the natural history of common metabolic complications of lipodystrophy syndromes, including diabetes mellitus and severe hypertriglyceridemia (fasting serum TG ≥ 500 mg/dL) in various subtypes of lipodystrophy syndromes, and to determine the incidence rates of clinical outcomes related to these metabolic complications in participants without these complications at baseline and describe the predictive value of their baseline characteristics for the these clinical outcomes. SABER is the DCC for this project and will provide project management, data management, and statistical analysis for this clinical trial.

MANAGE HF: A Multifaceted Adaptive Mobile Application to Promote Self-Management and Improve Outcomes in Heart Failure
Principal Investigator: Michael Dorsch, PharmD, MS
Sponsor: National Institute on Aging (NIA)
Manage HF is a Phase 3, multicenter, 12 week, randomized, and double-blind clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for patients with heart failure. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient’s heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and heart failure type (HFpEF versus HFrEF).
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MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Principal Investigator:  Riann Palmieri-Smith, PhD
Funded by: National Institute of Child Health and Human Development (NICHD)
This study is a single-center, randomized, double-blind, placebo-controlled, and parallel-group clinical trial to examine the combined efficacy of neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC) to promote the recovery of quadriceps strength, improve physical and biomechanical function, and reduce the risk of post-traumatic osteoarthritis (OA) after ACLR.
Study website coming soon...

Michigan eArly disease Progression cohort in COPD (MAP COPD)
Investigators: MeiLan Han, MD, MS; Wassim Labaki, MD, MS; Jeffrey Curtis, MD; Craig Galban, PhD
Sponsor: Taubman Institute and COPD Foundation
Michigan eArly disease Progression cohort in COPD (MAP COPD) is and observational study looking to gather new knowledge regarding screening for COPD and to understand the burden of early COPD disease in patients.  The aim of this study is to develop a disease progression cohort within the University of Michigan Health System to capture pulmonary function, symptom assessments and quantitative imaging among patients at risk for or with an established diagnosis of COPD, focusing however on “early” COPD (age 30-60 and GOLD stage 0,1 and 2).  Once the cohort is established, these data can subsequently be used to (a) understand how to identify this patient population within a health system and describe their symptom, exacerbation, radiologic and comorbidity burden; (b) collect longitudinal information to understand disease trajectory in this unique patient population; and (c) leverage this highly characterized patient pool for subsequent therapeutic clinical trials.  Ultimately, creation of this cohort at the University of Michigan would establish a model that could be applied within other health systems for establishing pools of well characterized, early stage patients at risk for disease progression to be leveraged for future studies
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MOIDS: Missed Opportunities for Improving Diagnosis in Pediatric Emergency Care 
Principal Investigator: Prashant Mahajan, MD MPH MBA
Sponsor: NIH Agency for Healthcare Research and Quality (AHRQ) 
MOIDS is an observational study to test an electronic health record (EHR) algorithm for identifying missed opportunities for diagnosis. The EHR-based algorithm and non-EHR measures will be reviewed across 5 pediatric emergency departments retrospectively and iteratively to refine the algorithms. Then the refined and tested algorithms will be applied to all pediatric ED visits at the sites prospectively. Expert reviewers will then assess all identified cases for judgement on whether the cases are missed opportunities, reviewing patient-related factors, patient-provider interactions, diagnostic tests, follow-up and tracking of diagnostic information, and referrals. Inter-rater reliability will be assessed. Frequency of MOIDS and characteristics associated with MOIDS will be assessed, along with the performance characteristics of the algorithm. SABER provides data management and statistical support for this study.
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PFF-R: Pulmonary Fibrosis Foundation Registry and Biorepository 
Principal Investigator: Cathie Spino, PhD
Sponsor: Pulmonary Fibrosis Foundation
The PFF-R is a prospective collection of data from over 2,000 patients with interstitial lung disease, coming from over 40 Pulmonary Fibrosis Foundation Care Center Network sites across the United States. Interstitial lung disease describes a diverse group of conditions where, in general, the lung tissue becomes thickened, stiff, and scarred (pulmonary fibrosis). This data is then made available to researchers for advance our knowledge about this disease. SABER provides project and data management for this study, and also provides statistical analysis, based on this collection of data, for 8-12 substudies per year which are proposed by interested researchers.
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PRECISIONS: Prospective Treatment Efficacy in IPF Using Genotype for NAC Selection
Data Coordinating Center (DCC) Principal Investigators: Cathie Spino, ScD, and Kevin Flaherty, MD, University of Michigan
Clinical Coordinating Center (CCC) Principal Investigators: Fernando Martinez, MD, Weill Cornell, and Imre Noth, MD, University of Virginia
Sponsor: NHLBI
PRECISIONS is a 6-year project which utilizes the Pulmonary Fibrosis Foundation Registry and Biorepository (see separate entry on this page) to perform a whole genome sequencing and proteomic analysis of around 1,400 people with interstitial lung disease.  As a proof of concept of how this data can be utilized to create a more precise approach to medicine, the project includes a large double-blind, placebo-controlled, randomized trial that will determine if people with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype will benefit from the use of N-acetylcysteine (NAC) in addition to standard of care for IPF.  SABER is the DCC for this project and will provide project management, data management, clinical monitoring, software development and statistical analysis for the clinical trial.

RETHINC: REdefining THerapy IN early COPD
Principal Investigators: MeiLan Han, MD and Prescott Woodruff, MD, MPH
Sponsor: NHLBI
RETHINC is a double-blind, placebo-controlled, randomized trial that aims to determine if current or former smokers with breathing problems despite normal breathing tests (spirometry) will benefit from the use of a bronchodilator, indacaterol/glycopyrrolate (Utibron™), for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The result of this trial will provide new fundamental clinical and therapeutic knowledge regardless of the outcome and important evidence that may contribute to the guidelines for the management of early COPD. SABER collaborates with investigators as the DCC for this study.
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SLSIII: Scleroderma Lung Study 
Principal Investigator: Dinesh Khanna, MD, MSC
Sponsor: BMS
SLS III is an investigator-initiated clinical research study focused on examining the combined anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating sclerodera-related interstitial lung disease. This research tests whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma-related lung disease. SABER provides project management, clinical monitoring, data management, software programming, and statistical analysis for this study.
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THRIVE: Feasibility Study for the Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia Trial
Principal Investigators: Michael Avidan, MBBCH, FCASA and  Sachin Kheterpal, MD, MBA
Sponsor: PCORI
The THRIVE feasibility study is looking at one of two different methods of anesthesia (total intravenous anesthesia with propofol or inhaled volatile anesthesia) will be given to participants during elective non-cardiac surgeries. The objective of this study is to evaluate the feasibility of a pragmatic, large-scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol vs. inhaled volatile anesthesia. The THRIVE study is looking to establish the proportion of patients who agree to participate, expressed as a fraction of those approached to enter the study; evaluate the proportion of patients who receive each random treatment allocation per protocol; and pilot data capture instruments and data management tools to assess the completeness of data collection and data management procedures. SABER provides study design and oversight, enrollment reporting, statistical analysis, data collection infrastructure, informatics pipelines, and participant interaction for this study.

TRAIL1: Treatment for Rheumatoid Arthritis Interstitial Lung Disease 
Principal Investigator: Ivan Rosas, MD
Sponsor: Genentech
This study is a phase 2, randomized, double-blind, placebo-controlled trial of pirfenidone for the treatment of rheumatoid arthritis associated interstitial lung disease. The primary aim of the study will assess the efficacy and safety of pirfenidone 2403 mg/day versus placebo in patients with RA-associated ILD. The primary efficacy outcome is defined by a composite endpoint of decline from baseline in percent predicted FVC of 10% or greater or death during the 52 week treatment period. Patients will receive blinded study treatment from the time of randomization until the Week 52 Visit. There will be 270 participants from approximately 40 sites in the United States, Canada and the United Kingdom enrolled in this study. SABER collaborates with investigators as the DCC for this study.
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Trans-Omics for Precision Medicine (TOPMed)
Principal Investigator: Goncalo Abecasis, Ph.D.
Sponsor: National Institutes of Health (NIH) National Heart, Lung and Blood Institute (NHLBI)
The TOPMed Informatics Research Center (IRC) at the University of Michigan provides advice to participating studies, sequencing centers and staff at the National Institutes of Health on the handling, processing and interpretation of large-scale sequence data. The IRC will jointly analyze sequence data and aid study investigators with informatics challenges, particularly for cross study analyses. A key goal of the Informatics Research Center is to make study results easily accessible to a broad range of scientists.  SABER is responsible for assisting the IRC with obtaining and managing any missing and/or needed data files (i.e. subject consent, subject sample mapping, sample attributes, pedigree and phenotype) for dbGaP upload and submission for curator review.  Additional support includes preview and approval of dbGaP submissions prior to release to the public as well as uploading of omics data (RNA sequencing, DNA methylation and metabolomics) via the dbGaP submission portal.
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Udall The University of Michigan Udall Center of Excellence for Parkinson's Disease Research
Principal Investigators: William Dauer, MD and Roger Albin, MD
Sponsor: NINDS
Up to 70% of patients with Parkinson's disease fall each year, quadrupling the rate of hip fractures, leading to extended hospitalizations, increased use of skilled nursing facilities and eventual nursing home placement. UM scientists have developed breakthrough evidence that these falls, which are resistant to currently available treatments, arise from the degeneration of brain cells that use the neurochemical acetylcholine. By integrating neuroimaging, behavioral and pharmacological studies in patients with Parkinson's disease and in animal models, we aim to further dissect the relationship between falls and abnormalities in these brain cells, and to develop the data necessary to launch a clinical trial of a novel treatment for these debilitating symptoms of Parkinson's disease. SABER acts as the biostatistics and data management center for this series of studies.
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