SDTM. Late Gadolinium Enhancement

The procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. The example PR dataset below shows the cardiac magnetic resonance imaging with two different MRI machines (PRTRT=MRI and PRLOC=HEART). The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset below.

The example CV dataset below shows the results of the LGE test measured using CMR imaging. The analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). There may be 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 CVANMETH variable.The procedure agents (AG) domain contains the agents administered to the subject 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-LGE-01-202 was not available, so only the date is represented in AGSTDTC variable.The device identifiers (DI) domain is used to represent the device information details. For this particular example, the device type was the only detail of interest to the researchers. The sequence number (DISEQ) is specific to each device; note there are two different CMR scanners noted with different values in the SPDEVID variable. Each scanners has a value of "1" for the DISEQ variable since there is only one record or row for each device.