Increasingly, Sponsors are using echocardiography to examine the structural health of the heart in clinical trials. Echocardiography is a non-invasive test that will allow Sponsors to view the anatomy, structure and function of the heart including:
- Complete cardiac chamber dimension
- Cardiac wall thickness, left ventricular mass
- Segmental wall motion analysis
- Cardiac valvular structure, function and competency
- Cardiac chamber pressures and filling capacities
- Contrast Echocardiography, including perfusion studies
(All acquired and measured according to ASE guidelines)
Due to the technical and sophisticated nature of the test, it is extremely important to work with a vendor that has expertise in echocardiography. With Biomedical Systems, you’ll work with one of our Board Certified Cardiologists Level III Echocardiographer who can assist or completely design your protocol to meet specific Sponsor and FDA requirements. Sites also receive protocol specific training at investigator meetings, teleconferences or videoconferences by the cardiologist or Registered Diagnostic Cardiac Sonographer designated to your study. In addition, Biomedical Systems offers comprehensive group training sessions at our coorporate office and/or one to one on-site training.
Biomedical Systems Echocardiography team is skilled in 2D, M-Mode, Contrast Agents and Doppler. Several advantages of working with Biomedical Systems include:
- Site certification for quality of echocardiograms ensures protocol is followed by site designated personnel and correct views are acquired.
- Registered Diagnostic Cardiac Sonographer ensures equipment has the required capabilities. Test echocardiogram is submitted before the study start with site notification via quality report form within 48 hours of receipt at Biomedical Systems.
- Analysis includes, but not limited to, ejection fraction, cardiac output, fractional shortening, left ventricular volumes, and left ventricular mass
- Specific Doppler measurements required to evaluate left ventricular diastolic function. Increased sensitivity of specific protocols designed by Biomedical Systems permits earlydetection of diastolic dysfunction/heart failure before overt changes in ejection fraction are seen.
- Single Board Certified Cardiologist Level III Echocardiographer interpretation for all subjects minimizes variability.
- Technical site support provided by a Registered Diagnostic Cardiac Sonographer.
For more information on Biomedical Systems Centralized Echocardiography Services, please click here.