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Late gadolinium enhancement (LGE) 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 be done on each of the cardiovascular segments as shown in Figure 1.[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

Info
titleNotes
  • CVORRES: Result of the measurement or finding as originally received or collected.
  • CVORRESU: Original units in which the data were collected. Unit for CVORRES.
  • CVSTRESC: Result value for all findings from CVORRES in a standard format or in standard units. If results are numeric, they should also be stored in numeric format in CVSTRESN.
  • CVSTRESN: Used for continuous or numeric results or findings in standard format; copied in numeric format from CVSTRESC.
  • CVSTRESU: Standardized units used for CVSTRESC and CVSTRESN.

The following example shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to late gadolinium enhancement.

Example

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ExampleSDTM. Late Gadolinium EnhancementExample
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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