SDTM. Late Gadolinium Enhancement

This example dataset shows the findings associated with a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. There are different levels of granularity noted to show various tests and details that might be represented. The research requirements will determine what level of granularity is needed. For example, a study using LGE may require LGE test in their data without the detail of the analysis method, or the researchers may be interested if the assessment was 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 of "Full-width half maximum" which is one of the types of analysis that may be done. The example provides how to represent this type of information if the researchers are interested in this type of information for the study data.

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

The ANMETH variable describes 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) which in this case applies to the CMR imaging.

TO DO - Describe the analysis method for LGE - three different methods:

• Full-width half maximum
• 5 standard deviations
• 6 standard deviations

The Cardiovascular System Findings (CV) domain represents physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. The findings from the CMR procedure for LGE are noted in this example. If LGE was not performed, it would not appear in the dataset.The Procedure Agent (AG) represents the agents administered to the participant as part of a procedure or assessment. The example AG dataset shows the timing of the gadolinium-based contrast, GD-DOTA. The time the contrast was given to participant 202 was not available, so only the date is represented in AGSTDTC variable.