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:
- Are there RV Cardiac Output and RV Cardiac Index measurements obtained?
- Would there be a baseline at diagnosis of DMD and then a regular follow-up? How often would this occur?
- What would the anticipated abnormalities be on follow-up CMR?
- We discussed if the ECG GATED MRI was the same as the Cardiac Magnetic Resonance Imaging Procedure. I think the conclusion was that it was so this is the CVMETHOD that was used.
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The following example shows the findings associated with a Cardiac Magnetic Resonance Imaging Procedure related to the ejection fraction.
| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DMD-CI | CV | 100 | 1 | RVSYSVOL | Right Ventricle Systolic Volume | 38 | mL/m2 | 38 | 38 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 2 | DMD-CI | CV | 100 | 2 | RVDIAVOL | Right Ventricle Diastolic Volume | 8 | mL/m2 | 8 | 8 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 3 | DMD-CI | CV | 100 | 3 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 38 | % | 38 | 38 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 4 | DMD-CI | CV | 100 | 4 | LVSYSVOL | Left Ventricle Systolic Volume | 100 | mL/m2 | 100 | 100 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 5 | DMD-CI | CV | 100 | 5 | LVDIAVOL | Left Ventricle Diastolic Volume | 60 | mL/m2 | 60 | 60 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 6 | DMD-CI | CV | 100 | 6 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 50 | % | 50 | 50 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 7 | DMD-CI | CV | 100 | 7 | LVCO | LV Cardiac Output | 4.5 | L/min | 4.5 | 4.5 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | |
| 8 | DMD-CI | CV | 100 | 8 | LVCI | LV Cardiac Index | 3.6 | L/min/m2 | 3.6 | 3.6 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 |