Essential for hypertension management.

Clinical Trial Services

Standard evaluation tools traditionally used in clinical trial protocols have limited ability to characterize the hemodynamic effects of pharmacological or device-based interventions. Noninvasive central blood pressure waveform analysis and carotid-femoral pulse wave velocity measurements directly assess aortic pressures and stiffness, thus providing a more comprehensive understanding of an individual’s cardiovascular health as well as a better characterization of the true hemodynamic impact of an intervention.

AtCor Medical’s Clinical Trial Services team is the industry’s most experienced group of individuals highly skilled in supporting central hemodynamic data collection in clinical trial protocols. For more than 10 years, we have provided equipment and support to trials spanning all sizes (single-center to global, multi-national studies) and phases of drug development, encompassing numerous cardiovascular and non-cardiovascular therapeutic areas. AtCor Medical’s clinical trial offerings include:

Technology

  • Office pulse wave analysis and simultaneous brachial blood pressure
  • Single-step carotid-femoral pulse wave velocity
  • 24-hour ambulatory brachial and central blood pressure
  • 24-hour ambulatory pulse wave analysis

Services

  • Study protocol design assistance
  • Personalized end-user training
  • Data management and site support through study closeout

Why measure central hemodynamics?

chartDerivation of the time-resolved ascending aortic pressure waveform through pulse wave analysis (PWA) assessments provides ascending aortic blood pressures which, due to the phenomenon of pulse pressure amplification, are more representative of the pressure to which the target organs are exposed than traditional brachial pressure. Extensive research has shown that although different pharmacological interventions may affect brachial pressures equivalently, their impact on central aortic pressure can differ significantly. This differential blood pressure effect has proven to be an important factor in explaining the heterogeneity of outcomes in major clinical trials. Further evaluation of the pressure waveform contour allows for more complete characterization of ventricular-vascular coupling through indices of pressure wave reflections, left ventricular load and arterial stiffness.

Carotid-femoral pulse wave velocity (PWV) is the AHA’s only recommended* method for noninvasive measurement of arterial stiffness. It is considered by many to be the most powerful cardiovascular risk factor and a valuable biomarker for cardiovascular risk prediction. Elevated PWV (increased aortic stiffness) is a precursor to hypertension and its persistent elevation during treatment is associated with high risk for an adverse outcome in those with established disease.

Experience

  • First FDA cleared device for noninvasive aortic pressure waveform measurements
  • More than 10 years of experience providing equipment and support services to clinical trials
  • Supported clinical trial sites in 35 countries on 6 continents
  • Successfully managed trials from Phase I to Phase IV over a wide range of therapeutic areas, including:
    • Hypertension
    • Heart Failure
    • Chronic Kidney Disease
    • COPD
    • Diabetes
    • Gout

Team

  • Data over-reads completed by industry-leading technical experts
  • Dedicated operational staff providing 24 hour global support
  • Most experienced clinical trial support team in the industry for central hemodynamic measurements

Procedural

  • Training and QA processes designed to maximize data quality and yield
  • Simple, automated, secure data transfers

*McDonald’s Blood Flow in Arteries, 6th Edition, 2011; AHA Scientific Statement: Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness, 2015.

© 2017 AtCor Medical Pty Ltd.

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