Key Researcher
Fred Apple, PhD, DABCC
Principal Investigator
Dr. Apple serves as the primary Principal Investigator. Dr. Apple is an internationally recognized expert in the fields of clinical chemistry and toxicology. He has lectured and published extensively in the field of cardiac biomarkers.
He serves as an associate editor of Clinical Chemistry, and is a member of the global task force on the universal definition of myocardial infarction and myocardial injury, consultant to the International Federation of Clinical Chemistry committee on clinical application of cardiac biomarkers (C-CB), member of the AACC Academy committee on laboratory medicine practice guidelines for myocardial infarction and heart failure, and is on the steering committee of the British Heart Foundation HighSTEACS trial.
Key Researcher
Karen Schulz, DC
Clinical Research Laboratory Director, Principal Investigator, and Co-Investigator.
Key Researcher
Hannah Brown, PhD
Principal Investigator and Co-Investigator
Dr. Brown serves as Principal Investigator (PI) and Co-Investigator (Co-I). She is the Medical Director of Clinical and Forensic Toxicology and Associate Medical Director of Clinical Chemistry at Hennepin County Medical Center. Her research focus is on finding meaningful ways to apply her skills in laboratory medicine, mass spectrometry, and data analytics to make an impact on health outcomes through diagnostic testing.
Dr. Brown is an instructor for the COMACC Clinical Chemistry Fellowship at Hennepin County Medical Center. She's the Association for Diagnostics & Laboratory Medicine (ADLM) Fellows Committee Chair, the Member Engagement Coordinator for the ADLM Therapeutic Drug Management and Toxicology Division, a member of the Hennepin Healthcare Practice Standards Committee, and a member of the ADLM Clinical Lab News Board of Editors.
Cardiac Biomarkers
Hennepin County Medical Center (HCMC) provides an excellent resource for patient enrollment and specimen acquisition for clinical studies and trials, outcomes assessments, and research studies in cardiology, SARS-CoV-2 (COVID-19), and other selected medical specialties. All research is approved by the HCMC/HHRI IRB committee for human subjects research in a timely period, for rapid study implementation.
Since 1982, Dr. Apple and his staff have carried out over 450 clinical studies, trials, and analytical evaluations. CBTL has served as a core lab for the National Institutes of Health (NIH), Veterans Affairs (VA) multicenter, and pharmaceutical studies. These studies focus on biomarkers of myocardial injury, including myocardial infarction, reperfusion success, outcomes risk assessments, decentralized point-of-care testing trials, CABG, PCI, renal disease, COVID-19, heart failure, inflammation, and other non-ischemic mechanisms of injury. In addition, the laboratory serves as a center of excellence for forensic and clinical toxicology applied research studies.
The Hennepin Healthcare Research Institute (HHRI)/Hennepin Healthcare serves as a Clinical Laboratory Improvement Amendment (CLIA) certified (#2D2019908) comprehensive center of excellence for:
- Clinical studies and outcome research.
- Technology assessment for instrumentation and method evaluation.
- Reference laboratory capabilities for in vitro diagnostic, pharmaceutical, and commercial vendors.
- Clinical, applied, and basic research investigations of novel and established biomarkers in cardiology, stroke, traumatic brain injury, diabetes, and SARS-CoV-2 (COVID-19).
- Near-bedside, Point-of-Care Testing (POCT).
- Clinical and applied investigations addressing SARS-CoV-2 antibody and antigen utilization, cardiac and inflammatory risk biomarkers, and infectious disease.
- Customized assay and instrument evaluations for central laboratory as well as for point-of-care, near-bedside testing devices.
- Design and implementation of clinical and analytical trials for FDA 510(k) and PMA protocols, along with FDA regulations, Emergency Use Authorization (EUA), CE Marking, and China FDA regulatory clearance.
- Testing on human and veterinary serum, plasma, or tissue samples.
- Reference range determination customized for age, ethnicity, and gender diversity.
- Diverse instrumentation to support comparative testing.
- Expert medical and technical consultative services specializing in a wide range of analytes and regulatory issues.
- Cardiac troponin I and T, including high-sensitivity assays
- BNP, NT-proBNP, and proBNP, MR-proANP
- Total Creatine Kinase (CK)
- CKMB mass and isoforms
- Myoglobin
- LD isoenzymes
- Glycogen phosphorylase BB
- Fatty acid-binding protein
- D-dimer
- Free fatty acids, unconjugated
- Placental Growth Factor
- Myeloperoxidase
- CD 40 Ligand
- Interleukin (6,10)
- Metalloproteinases
- Pregnancy Associated Plasma Protein A (PAPP-A)
- hs-CRP
- Prostate Specific Antigen (PSA)
- Adrenocorticotropic hormone (ACTH)
- Total Thyroxine (TT4)
- Infectious Diseases - Hepatitis B Virus (HBV), Hepatitis B surface antibody (HBsAb), Hepatitis A Virus (HAV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV)
- Novel biomarkers of ischemia, myocardial dysfunction, and inflammation
- SARS-CoV-2 (Covid-19) antigen and antibodies: IgG, IgM, IgA; nucleocapsid (N-protein), spike protein,n and receptor binding domain (RBD)
- Clinical Trials.Gov studies:
- SAFETY - Use of High Sensitivity Cardiac Troponin In Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction: NCT04280926
- SEIGE - Safe Emergency Department DIschaGE Rate: NCT04772157
- MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon: NCT05853042
- CONTRAST - COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial: NCT03214029
- UTROPIA - Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes: NCT02060760
- Toxicology – postmortem forensic toxicology, drugs of abuse, therapeutic drug monitoring
- Diabetes
- Obesity
- Stroke
- Sepsis
- Pulmonary Embolism
- Metabolic – electrolytes, beta-hydroxybutyrate, vitreous humor analysis
- Anemia – B12, folate, ferritin
- Tumor markers
- Traumatic brain injury (TBI)
- Infectious Disease
- Urinalysis
- Hepatitis
- SARS-CoV-2 (COVID-19) serology and antigen diagnostics
Automated Platforms:
- Abbott Architect i2000 SR
- Abbott Alinity i
- Siemens ADVIA Centaur XP
- Siemens ADVIA Centaur XPT
- Siemens Immulite 2000 XPi
- Siemens Atellica IM 1600
- Beckman Coulter Access2
- Beckman Coulter DxI 800
- Beckman Coulter DxI 9000
- Beckman Coulter DxC 700 AU
- Ortho Clinical Diagnostics 5600
- Roche Cobas e411
- bioMérieux Mini-Vidas
- Randox Evidence Investigator
- ET Healthcare Pylon
Point of Care:
- Alere Triage
- Siemens Stratus CS
- Abbott POC i-Stat
- Abbott i-STAT
- MKI Pathfast
Other Instrumentation:
- Artel PCS2—Pipette Calibration System
- Beckman-Coulter Allegra 6 Centrifuge, Vortex, Orbital Shaker, and Balances
- Molecular Devices Micro-Plate Reader and Scanner
- ThermoScientific Heraus Megafuge 16
- Eppendorf 5430 Microcentrifuge
- Denville Scientific 300D Microcentrifuge
- Stat Spin Express 3
- Water Bath Precision 183
- Millipore CLX 7080 Water Filtration System
- Isensix Temperature Monitoring System
Fred S Apple, PhD/DABCC/FACSM
Principal Investigator - Hennepin Healthcare Research Institute
Medical Director of CAP FDT Toxicology Laboratory / HCMC
Professor, Laboratory Medicine & Pathology - University of Minnesota
apple004@umn.edu
612-873-3324
Karen M. Schulz, DC
Principal Investigator and Co-Investigator – Hennepin Healthcare Research Institute
Clinical Research Laboratory Director
kschulz@hhrinstitute.org
612-873-6893
Hannah Brown, PhD
Medical Director, Clinical & Forensic Toxicology; Hennepin Healthcare/HCMC
Principal Investigator and Co-Investigator – Hennepin Healthcare Research Institute
Sarah Drawz, MD, PhD
Chairperson of the Laboratory Medicine and Pathology; Hennepin Healthcare/HCMC
Stephen W. Smith, MD
Emergency Medicine attending physician – Hennepin Healthcare/HCMC
Professor, Department of Emergency Medicine – University of Minnesota
Co-Investigator Hennepin Healthcare Research Institute
Yader B. Sandoval, MD/FACC/FSCAI/FESC
Co-Chairman, Center for Coronary Artery Disease – Minneapolis Heart Institute Foundation
Interventional Cardiologist
Co-Investigator – Hennepin Healthcare Research Institute
Brittany Lindgren, MLS (ASCP)
Medical Laboratory Scientist
Kathryn Worrell, MLS (ASCP)
Medical Laboratory Scientist
Kylie Meyer, MLS (ASCP)
Medical Laboratory Scientist
Alanna Ladd, MLS (ASCP)
Medical Laboratory Scientist
Sarah Elmer, MS
Research Coordinator
Hawi Amente, BS
Research Coordinator
Anne Sexter, MPH
Biostatistical Program Manager
Cardiac Biomarker Trials Laboratory
Hennepin Healthcare Research Institute
914 South 8th Street, S3.110
Minneapolis, Minnesota 55404
Phone: 612-873-6893
Dr. Fred Apple - apple004@umn.edu
Dr. Karen Schulz - kschulz@hhrinstitute.org
Dr. Hannah Brown - Hannah.Brown@hcmed.org
HHRI is not responsible for the content on external websites. The appearance of these links on the HHRI website does not constitute an endorsement by HHRI.
- University of Minnesota Department of Laboratory Medicine and Pathology
- Academy of Clinical Laboratory and Physicians, and Scientists
- Association for Diagnostics & Laboratory Medicine
- The Society of Forensic Toxicology
- Clinical Trials.GOV
- International Federation of Clinical Chemistry
- American Heart Association
Key Researcher
Fred Apple, PhD, DABCC
Principal Investigator
Dr. Apple is an internationally recognized expert in the fields of clinical chemistry and toxicology. He has lectured and published extensively in the field of cardiac biomarkers.
Dr. Apple serves as an associate editor of Clinical Chemistry, and is a member of the global task force on the universal definition of myocardial infarction and myocardial injury, chair of the International Federation of Clinical Chemistry task force on clinical application of cardiac biomarkers, member of the AACC Academy committee on laboratory medicine practice guidelines for myocardial infarction and heart failure, and member of the AACC Clinical Societies Collaboration Committee and is on the steering committee of the British Heart Foundation HighSTEACS trial. He is the principal investigator of the UTROPIA, CONTRAST, SAFETY, and SEIGE clinicaltrials.gov studies.