Clinical Trial Services

Increase Confidence and Optimize Clinical Development Efficiency

Central hemodynamic assessments such as aortic pressure waveform analysis and pulse wave velocity measurements present investigators with a better understanding of the cardiovascular effects of an intervention. By characterizing ventricular-arterial interactions, pulse wave analysis and arterial stiffness measures can independently predict response to therapy, target organ damage and risk of a  cardiovascular event, providing important insights that increase confidence in clinical program development decision-making.

Additionally, post-hoc analysis with SphygmoCor allows researchers to evaluate large animal blood pressure waveforms to assess the effects of experimental interventions on wave reflections and other hemodynamic variables.

AtCor Medical’s industry-leading SphygmoCor technology and global clinical trial services provides sponsors with reliable, high-yield central hemodynamic data, enhancing trial efficiency. The team’s experience spans pre-clinical through phase four clinical trials. Click here to learn more.

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
  • Pre-clinical pressure waveform analysis

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.