Echo Core Lab is a Key for Using Echocardiography in Clinical Trials

Echocardiography is a noninvasive method to assess cardiac anatomy, function, and hemodynamics and may provide important data on the effects of a new drug or medical device. In many cardiovascular clinical trials, echocardiography data are used for assessing eligibility and endpoints. At the same time, the main disadvantage is operator dependency for acquisition, measurement and interpretation which introduces high variability and potential for human error.  It is therefore essential to standardize echocardiography acquisition, measurement, and interpretation, especially in multicenter clinical trials. This can be achieved by an echo core lab.

What is Echo core lab

Standardization of image acquisition among all clinical sites is accomplished through a study specific echo manual as well as a training workshop. Additionally regular visits to sites and continuous feedback may improve standardization throughout the clinical sites. A Core Lab should have an experienced physician echocardiographer who is able to identify inter- and intra-observer variability to maintain standardization regarding acquisition, measurement and interpretation of echocardiographic variables.

For quality reasons all echocardiographic assessments will be performed within multiple cardiac cycles. That is why image acquisitions should mostly include three cardiac cycles for patients in sinus rhythm. . In the case of atrial fibrillation, five cardiac cycles are to be measured for standardized assessment and calculating the mean value. Within a core lab one dedicated physician echocardiographer will perform all necessary measurements for entire trial and proof readings will be performed by another physician echocardiographer. In addition, assessment and interpretation of echo variables are performed blinded with regard to subjects as well as timepoints.

Take Away Message

An Echo Core Lab is essential for reliability of echocardiographic data and should be integrated especially in multicenter trials to minimize random errors and inter-observer variability. As assessment and interpretation of data within a core lab allows an independent and more accurate analysis. ‘Hands-on’ training modules for each clinical site and reduces variability of image acquisition and improves data quality.

Reference 

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