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"In DMD patients, LGE occurs early, is progressive and increases with both age and decreasing LVEF. Segmentally, the incidence of the number of positive LGE segments increase with age and lower LVEF. Older patients and those who died during the study period had more septal LGE involvement. The current studies suggest that the time course and distribution of LGE-positivity may be an important clinical biomarker to aid in the management of DMD-associated cardiac disease." (ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-15-107)

Late gadolinium enhancement (LGE) is an assessment made with cardiac magnetic resonance (CMR) imaging that includes gadolinium contrast administration. The test increases over time for patients with DMD. Early onset LGE may be used as a prognostic factor since cardiac function has been shown to decline more rapidly for these patients.[5]

LGE assessments can is done to assess accumulation of gadolinium contrast material in the tissue with increased extracellular space to determine both left and right ventricle fibrosis (ref: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801263/). For LGE, the assessment relates to the timing of the reading showing whether the contrast is present or not (shown as positive or negative). If the LGE is noted as present, more assessments may be done, such as presence per segment and the percentage of presence per segment. Since contrast is important to these assessments, the Procedure Agents (AG) dataset is shown with this example.
LGE assessments may be done on each of the cardiovascular segments as shown in Figure 1. (ref: https://www.ahajournals.org/doi/full/10.1161/hc0402.102975)[6]

Excerpt Include
Figure 1. Left Ventricular Segments
Figure 1. Left Ventricular Segments

The SDTM examples in this section show the findings of a CMR imaging procedure with late gadolinium enhancement. The level of granularity varies with the type of test used; research requirements will determine what level of granularity is needed.

Example

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SDTM. Late Gadolinium Enhancement
SDTM. Late Gadolinium Enhancement

Info

For more information on the domains used in this section see:

  • Procedures (PR) - SDTMIG v3.4, Section 6.1.5
  • Cardiovascular System Findings (CV) - SDTMIG v3.4, Section 6.3.7.2
  • Procedure Agents (AG) - SDTMIG v3.4 Section 6.1.1
  • Device Identifiers (DI) - SDTMIG-Medical Devices v1.1, Section 3.1

The SDTMIG is available at https://www.cdisc.org/standards/foundational/sdtmig.

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