Key Researcher
Fred Apple, PhD, 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.
Cardiac Biomarkers
The Hennepin Healthcare Research Institute/HCMC Cardiac Biomarker Trials Laboratory (CBTL) provides a CLIA certified, reliable and 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
- clinical and applied investigations addressing SARS-CoV-2 antibody and antigen utilization, cardiac and inflammatory risk biomarkers
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 350 clinical studies, trials, and analytical evaluations. 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.
Services provided by the laboratory include:
- 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 FDA regulations, Emergency Use Authorization (EUA), and CE Marking
- Testing on human and veterinary serum, plasma or tissue samples
- Reference range determination customized for age, ethnic 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
Current Research
Cardiac Biomarkers Studied:
- 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)
- hsCRP
- Novel biomarkers of ischemia, myocardial dysfunction and inflammation
- SARS-CoV-2 (Covid-19) antigen and antibodies: IgG, IgM, IgA; nucleocapsid (N-protein), spike protein and receptor binding domain (RBD)
Other Areas
- Toxicology – postmortem forensic toxicology, drugs of abuse, therapeutic drug monitoring
- Diabetes
- Obesity
- Stroke
- Pulmonary Embolism
- Metabolic – electrolytes, beta-hydroxybutyrate, vitreous humor analysis
- Anemia – B12, folate, ferritin
- Tumor markers
- Traumatic brain injury (TBI)
- Infectious Disease
- Urinalysis
- SARS-CoV-2 (Covid-19) serology and antigen diagnostics
Instrumentation
Automated Platforms:
- Abbott Architect i1000 SR and i2000 SR
- Abbott Alinity I
- Siemens ADVIA Centaur CP
- Siemens ADVIA Centaur XP
- Siemens ADVIA Centaur XPT
- Siemens Immulite 2000
- Siemens Atellica
- Beckman Coulter Access2
- Beckman Coulter DxI 800
- Beckman Coulter DxI 9000
- Beckman Coulter DxC 700 AU
- Ortho Clinical Diagnostics Vitros ECi
- Ortho Clinical Diagnostics 5600
- Roche Cobas e411
- bioMérieux Vidas, Mini-Vidas
- Brahms Kryptor Plus
- TECAN EVO 150
Point of Care:
- Alere Triage
- Siemens Stratus CS
- Abbott POC 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
- Tecan EVO 150 Automated Microtiter Plate System
- ThermoScientific Heraus Megafuge 16
- Eppendorf 5430 Microcentrifuge
- Denville Scientific 300D Microcentrifuge
- Stat Spin Express 3
- Water Bath Precision 183
- Millipore AFs-16D Water Filtration System
- Isensix Temperature Monitoring System
Contact Us
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
Karen Schulz - kschulz@hhrinstitute.org
Key Researcher
Fred Apple, PhD, 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.
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