Notes
- 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.
Questions for the Team
- 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
Measurements such as Cardiac Output (as seen in the example below) and Spirometry are effected by Body Service Area. It is important in the DMD population to ensure the height and weight are current for accurate data collection (especially as the participant becomes wheelchair bound). Height and weight are represented in the Vital Signs domain. Refer to the SDTMIG v3.4, Section 6.3.13 for more information.
The following example shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction.
Example
Unable to render {include} The included page could not be found.