Cardiorespiratory failure is a common cause of death for patients with Duchenne muscular dystrophy (DMD). Current therapies may delay the progression of heart failure for this population. Measuring left ventricular ejection fraction (LVEF) regularly can show the rate of decline in left ventricle function for a patient.[1]
This section illustrates how the results of several systolic function tests, and accompanying data, are represented using the SDTM.
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| SDTM. Basic CMR Tests - Systolic Function |
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| SDTM. Basic CMR Tests - Systolic Function |
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For more information on the domains used in this section, see: - Demographics (DM) - SDTMIG v3.4, Section 5.2
- Vital Signs (VS) - SDTMIG v3.4, Section 6.3.13
- Cardiovascular System Findings (CV) - SDTMIG v3.4, Section 6.3.7.2
- Laboratory Test Results (LB) -
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| title | Questions for the Team |
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- Would there be a baseline at diagnosis of DMD and then a regular follow-up? How often would this occur?
- Yes, but maybe not at diagnosis, sometimes annually or every other year
- What would the anticipated abnormalities be on follow-up CMR?
- Changes in LVF, changes in strain or delayed enhancement, parametric mapping
- Do the CMR images have any cardiac labs done at the same time that would need to be linked (such as a BNP)? If they say yes, I thought we could include text regarding this. I am not sure if it would just be part of the data and not necessarily need to be linked with LNKID.
- NTproBNP, BNP, troponin are the most common
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- SDTMIG v3.4, Section 6.3.
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- 6
- Related Records (RELREC) - SDTMIG v3.4, Section 8.2.1
The SDTMIG is available at https://www.cdisc.org/standards/foundational/sdtmig. |
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| SDTM. Ejection Fraction | SDTM. Ejection Fraction