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The example includes the representation of some device information (i.e., device manufacturer, software, version information, and the specific settings for each subject. Study requirements determine what data is needed. The device identifier is represented using SPDEVID and PRREFID. This information shows what device is used and the accession number or procedure reference identifier associated with the specific procedure for subject DMD-RT-01-301. The SPDEVID variable is used to relate this procedures (PR dataset ) dataset to other records by the device (in this case, the CMR machine).
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRSTDTC |
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| 1 | DMD-RT | PR | DMD-RT-01-301 | ABC001 | 1 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING | 2023-08-01 |
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The example cardiovascular system findings (CV) dataset below shows how to represent longitudinal relaxation time, transverse relaxation time and extracellular volume findings from CMR. The timing of the contrast specificity is documented using the CVTPT = BEFORE or AFTER contrast administration. This example includes records for an unreadable image and an unperformed test. CVSTAT was populated with "NOT DONE" and CVREASND was populated with the reason the result was not provided or the procedure was not done. A non-standard variable is used to represent image quality.
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Rows 1-6: | Show the longitudinal relaxation time and the transverse relaxation time for different segments of the heart prior to contrast. | Rows 7-8: | Show the longitudinal relaxation time and myocardial extracellular volume for different segments of the heart after contrast. | Row 9: | Shows an unreadable CMR result for participant DMD-RT-01-302, CVREASND = "NON-EVALUABLE IMAGE".
| Row 10: | Shows participant DMD-RT-01-303 did not have a CMR procedure because they were unable to place an intravenous access line, CVREASND = "UNABLE TO PLACE INTRAVENOUS LINE".
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVSTAT | CVREASND | CVLOC | CVMETHOD | CVLOBFXL | VISITNUM | VISIT | CVTPT | CVTPTREF | CVDTC |
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| 1 | DMD-RT | CV | DMD-RT-01-301 | 1 | T1 | LONGITUDINAL RELAXATION TIME (T1 TIME) | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 2 | DMD-RT | CV | DMD-RT-01-301 | 2 | T1 | LONGITUDINAL RELAXATION TIME (T1 TIME) | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 3 | DMD-RT | CV | DMD-RT-01-301 | 3 | T1 | LONGITUDINAL RELAXATION TIME (T1 TIME) | | ms | | 980 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 4 | DMD-RT | CV | DMD-RT-01-301 | 4 | T2 | TRANSVERSE RELAXATION TIME (T2 TIME) | | ms | 45 | 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 5 | DMD-RT | CV | DMD-RT-01-301 | 5 | T2 | TRANSVERSE RELAXATION TIME (T2 TIME) | | ms | 40 | 40 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 6 | DMD-RT | CV | DMD-RT-01-301 | 6 | T2 | TRANSVERSE RELAXATION TIME (T2 TIME) | | ms | 48 | 48 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 7 | DMD-RT | CV | DMD-RT-01-301 | 7 | T1 | LONGITUDINAL RELAXATION TIME (T1 TIME) | | ms | 450 | 450 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 8 | DMD-RT | CV | DMD-RT-01-301 | 8 | MYECV | MYOCARDIAL EXTRACELLULAR VOLUME | | % | 25 | 25 | % | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 9 | DMD-RT | CV | DMD-RT-01-302 | 1 | CVALL | CARDIOVASCULAR SYSTEM FINDINGS |
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| | | | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION | 2023-08-05 |
| NON-EVALUABLE IMAGE | | 10 | DMD-RT | CV | DMD-RT-01-303 | 1 | CVALL | CARDIOVASCULAR SYSTEM FINDINGS |
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| | UNABLE TO PLACE INTRAVENOUS LINE | | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION | 2023-08-05 |
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| Variable | Label | Type | Role | Origin |
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| CVOIQ | Overall Image Quality | text | Non-standard Record Qualifier | CRF |
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The example procedure agents (AG) dataset shows details for the gadolinium based contrast used for the procedure.
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