SDTM. Late Gadolinium Enhancement

This example 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.

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. The variable SPDEVID is used to represent the imaging device identifier information provided in the DI dataset below. For more information on this domain, see Section 6.1.5, Procedures (PR), in the SDTMIG v3.4.

The example CV dataset below shows the results of the LGE test measured using cardiac magnetic resonance (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. For more information on this domain, see Section 6.1.1, Procedure Agents (AG), in the SDTMIG v3.4. 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.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 DI Sequence number (DISEQ) is specific to each device; note there are two different CMR Scanners each with different identifiers in the Sponsor Device Identifier (SPDEVID) variable and each have a value of "1" for the DISEQ variable. The reason because there is only one record or row for each device.