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Cardiac Biomarkers

FApple

Key Researcher

Fred Apple, PhD, 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. 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, 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. 

KSchulz

Key Researcher

Karen Schulz, DC, serves as the Clinical Research Laboratory Director, Principal Investigator and Co-Investigator.

Laboratory Staff

Cardiac Biomarkers

The Hennepin Healthcare Research Institute/HCMC Cardiac Biomarker Trials Laboratory (CBTL) provides a CLIA certified; CLIA # 2D2019908, reliable and comprehensive center of excellence for:

CBTL photo 03.03.21
  • 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 400 clinical studies, trials, and analytical evaluations. CBTL has served as a core lab for NIH, 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.

 

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), CE Marking, and China FDA regulatory clearance.
  • 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)
  • 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 dIscharGE 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
    • UTROPIA - Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes: NCT02060760

Other Areas

  • 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

 

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 IM 600
  • Beckman Coulter Access2
  • Beckman Coulter DxI 800
  • Beckman Coulter DxI 9000
  • Beckman Coulter DxC 700 AU
  • Ortho Clinical Diagnostics 5600
  • Roche Cobas e411
  • bioMérieux Vidas,
  • bioMérieux Mini-Vidas
  • Randox Evidence Investigator
  • ET Healthcare

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 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
Dr. Karen Schulz - kschulz@hhrinstitute.org

Image of Dr. Fred Apple

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.

Laboratory Staff

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