Industry Studies
We appreciate our industry partners and are dedicated to performing these important industry funded studies to the highest scientific standards.
We welcome industry collaborations and are happy to respond to additional queries - please email Penney at penegonz@umich.edu to begin a conversation.
Symphony IL-6 for COVID-19 Patients
Interleukin 6 (IL-6) is a pro-inflammatory cytokine that is highly expressed during Covid-19 infections.
BlueJay Diagnostic's Symphony IL-6 device is a a near-patient biomarker detection platform intended to improve healthcare outcomes by providing quantitative IL-6 results vital for triage and acute care situations, within 20 minutes of collection of patient blood samples. Symphony combines modern advances in interrupted microfluidics, nanotechnology, and enzyme linked immunosorbent assays (ELISA) to enable clinical chemistry results faster to aid in determining a patient's risk of invasive mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.
Learn more at ClinicalTrials.gov
CVMobius2 - Cardiovascular Multicenter Observation Investigation of Lipid Care in the United States-2
A Phase IV prospective cohort study using Electronic Health Record (EHR) data through the National Patient-Centered Clinical Research Network (PCORnet), with annual data pulls over the course of four years and across 25 health systems, this study, CVMobius2, will examine and track lipid lowering therapy utilization and LDL-C levels in adults with atherosclerotic cardiovascular disease (ASCVD).
CVMobius2 will describe the proportion of patients with established ASCVD who are treated according to American College of Cardiology and American Heart Association guideline recommendations for lipid lowering therapies.
Secondary objectives include assessing the baseline characteristics and comparability of subjects with established ASCVD who initiate a PCSK9 inhibitor to those potentially eligible who do not start PCSK9 inhibitor treatment; assessing the clinical outcomes in adults by LDL-C levels over time; exploring health-system heterogeneity of utilization of non-statin therapies; and examining lipid levels over time by treatment status.
CVMobius2 is a follow-up to the CVMobius trial, which prospectively followed 750 patients.
Examine your risk levels for (ASCVD)
Learn more about PCORnet's research opportunities.
Saliva SARS-CoV-2(2019-nCoV) Antigen Nanocarbon Assay Test Kit Clinical Evaluation
We started enrolling subjects in this study in March 2023. This study recruits subjects who are experiencing Covid-19 symptoms or who were recently exposed.
The study is investigating s a saliva, nanocarbon assay at-home test kit to determine the efficacy for detection of Covid-19. Dr. Hayek's lab at the University of Michigan is one of three sites across the country, including Duke University and Cornell University.
Shingrix Immune Response Study
We have been actively enrolling subjects with break-through Shingles cases - people who have been diagnosed with Shingles or are experiencing a Shingles flare within 6 months of their Shingrix shot.
The study will examine the role of immune responses in varicella-zoster virus (VZV - the Shingles virus) infection. With a better understanding we hope to learn how to prevent infections and create more effective treatment options for the future.
LOGAN-CV - Clinician Engagement in Guideline Based Management of LDL-C for Patients at Very High Risk for a Future Atherosclerotic Cardiovascular Disease (ASCVD) Event
This study aims to determine whether a multi-faceted intervention including educational modules and platform access provided to Clinician-Participants can impact the clinical outcomes in patients with recent heart attacks and uncontrolled LDL-C, providing health systems with tools to help close costly gaps in care and adopt guideline driven framework, and providing patients the most up-to-date management of their LDL-c, with the potential for a reduction in future cardiovascular events.
Clinical Trials
Atrium - A Phase 3, Investigator-initiated, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Abatacept compared to Placebo in Hospitalized Participants with Immune Checkpoint Inhibitor Associated Myocarditis
This trial enrolls patients who are diagnosed with myocarditis (the inflammation of the heart muscle, which can lead to weakening of the heart muscle, dangerous rhythms of the heart, or even death) following treament with Immune Checkpoint Inhibitors (ICI).
The primary aim is to test whether Abatacept (which is approved by the FDA for treatment of adults with Rheumatoid Arthritis under the trade name Orencia), as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI).
Participants are treated with Abatacept infusion during hospitalization and are followed for 6 months, measuring biomarkers such as Electrocardiograms (ECG), Echocardiograms (echo), electrolytes and proteins in blood samples to test for kidney function or infections, and Quality-of-Life assessments.
The FDA has not approved abatacept to treat myocarditis.
Learn more on ClinicalTrials.gov