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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]

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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
titleQuestions for the Team
  1. Is "CARDIAC WALL" okay for location?  
    1. It is the only term in CT that fits.  It seems wrong because technically if there is a mass within the heart, it would be seen on the CMR imaging.
  2. All the segments in the CT is for the LV, is it safe to assume the same segments for RV?
  3. Request SME review and update of text and values.

Note from standards discussion - Determined this would be an indicator test and there is an additional term LGE percentage. → is there anything different to do with this?

Late Gadolinium Enhancement (LGE) is an assessment made with CMR imaging that includes gadolinium contrast administration. The test is done to assess for gadolinium contrast material accumulation in the tissue with increased extracellular space to determine both left and right ventricle fibrosis (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801263/). For LGE, the assessment relates to the timing of the reading showing whether or not the contrast is present or not at the specific time of the reading (would be determined by the protocol but typically is noted approximately 10 minutes after contrast injection). If the LGE is noted as present, more assessments may be done such as presence per segment and the percentage of presence per segment.

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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