SDTM. Late Gadolinium Enhancement

This example dataset shows the findings of a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. The level of granularity varies with the type of test used. Research requirements will determine what level of granularity is needed. For example, a study may not include the analysis method. Alternatively, researchers may be interested in understanding if the assessments were done visually or with quantitative methods. If the study includes an assessment of each segment, such as with the Segmental Late Gadolinium Enhancement Percentage, there may be interest in representing the quantitative analysis method. This example illustrates how to represent this type of information. (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-16-45)

The procedures (PR) domain is used to represent diagnostic, preventive, and therapeutic activity. The example PR dataset shows the cardiac magnetic resonance imaging with two different MRI machines. The variable SPDEVID represents the imaging device identifier information provided in the DI dataset below.

The cardiovascular system findings (CV) dataset shows the results of the LGE test measured using cardiac magnetic resonance (CMR) imaging. The CVANMETH variable is used to represent the analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). There are machine-centric analysis methods inherit to the type of machine (e.g., full-width half maximum, 5 standard deviations, 6 standard deviations). (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-12-21) If this information is of interest to the study, it would be represented using the ANMETH variable.The procedure agents (AG) domain represents the agents administered to the participant as part of a procedure or assessment. The example AG dataset below shows the timing of the gadolinium-based contrast, GD-DOTA. The time the contrast was given to participant DMD-EFLGE-01-202 was not available, so only the date is represented in AGSTDTC variable.