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For pediatric patients with DMD, the contrast administration procedure associated with LGE testing may be challenging. Non-contrast CMR methods, such as T1 mapping, exist and are useful for early myocardial remodeling detection. It has been found that T1 levels are typically elevated in patients with DMD, compared to healthy individuals, even prior to LGE. (ref: https://jcmr-online.biomedcentral.com/articles/10.1186/s12968-020-00687-z)[8]

The following SDTM examples show T1, T2, and extracellular volume test results. This example includes device information (i.e., device manufacturer, software, version information, and the specific settings for each subject); however, study requirements will determine what data should be included.

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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
  • Device Properties (DO) - SDTMIG-Medical Devices v1.1, Section 3.7
  • Device In-Use (DU) - SDTMIG-Medical Devices v1.1, Section 3.2
  • RELREC - SDTMIG v3.4 Section 8.2

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

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