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. (ref: https://jcmr-online.biomedcentral.com/articles/10.1186/s12968-020-00687-z), even prior to LGE.[8]
The following SDTM examples show parametric mapping ( T1, T2, and extracellular volume ) test results. For brevity, a limited sample of tests after contrast are shown in this example. The This example includes some 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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For more information on the domains used in this section see:
The SDTMIG is available at https://www.cdisc.org/standards/foundational/sdtmig. |
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