Core Lab Activities
The UCSF Quantitative Echocardiography Core Laboratory
The UCSF Quantitative Echocardiography Core Laboratory (ECL) has been in existence for over 25 years and helped to pioneer the use of emerging echocardiographic technologies, including MD mode, 2D, and 3D echo. We have been involved in a number of landmark clinical trials and have recognized expertise especially in the areas of dyssynchrony, LV function assessment and assessment of valvular heart disease.
We offer a number of services that include:
- Helping designing research protocols in collaboration with study sponsors
- Providing training to participating centers, designing training materials, and providing on going feedback to study sites on echocardiogram quality
- Designing case report forms (CRFs) and managing primary and secondary data in a safe and secure manner
- Performing in depth quantitative analysis of adult echocardiograms including but not limited to: LV and RV function, strain/strain rate analysis (LV, RV and LA), valvular heart disease assessment, and congenital heart disease assessment
- Providing in depth quality control analysis
- Preparing abstracts and manuscripts in collaboration with the investigators of multi center studies
Our lab has access to some of the world’s experts in cardiovascular disease, heart failure and electrophysiology which we leverage in designing new protocols for sponsors.
We use only highly trained senior sonographer/technicians to perform quantitative measurements. All studies are formally reviewed and read by experienced, board-certified echocardiologists.
Our lab understands the time, effort and cost burdens of assessing both research and clinical echocardiograms and strives to design echocardiography protocols which are parsimonious yet help answer all the relevant clinical question(s) or study aims. We are able to be highly competitive in pricing with many commercially available core labs due to staffing and support from the UCSF Division of Cardiology.
We follow the most recent American Society of Echocardiography Standards and conduct all of our operations under FDA guidelines and Good Clinical Practice.
If your company is looking for a central laboratory to perform any of the above services for a new study, please contact the ECL Director, Atif Qasim. MD, MSCE at firstname.lastname@example.org.
Electrocardiography Core Laboratory
Under the direction of Byron Lee, MD, and Thomas Everett, PhD, the Electrocardiography Core Lab (ECGL) conducts all its operations under FDA guidelines and Good Clinical Practice. The ECGL can serve as the central laboratory that will independently analyze 12-Lead ECG, signal averaged ECG, P-wave ECG, Holter, stress test, and Baroreflex Sensitivity (BRS) studies performed by participating centers. Sample studies are reviewed from each of the participating sites and feedback is provided to the center to ensure that quality signals are collected with low signal to noise ratios for accurate analysis, and to ensure adherence to the protocol.
Scope of Work
The ECGL will provide a reproducible, qualitative and quantitative analysis of all data. At the request of the study sponsor, the ECGL will develop a Statement of Work document that will outline the sponsor’s expectations, the protocol requirements, and the ECGL’s responsibilities and the scope of work for the trial.
All data that comes into the ECG Core will be subject to quality control. Data from each of the tests that are involved in the study will be viewed for noise and data variability. The 12-Lead ECG, signal averaged ECG, P-wave ECG, Holter, and stress test are analyzed using GE Healthcare analysis programs (MUSE – ECG, MARS – Holter, Cardiosoft – stress test). Baroreflex Sensitivity (BRS) studies are analyzed using Task Force Monitor and custom Matlab programs.