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The following example shows the parametric mapping (T1 mapping, T2 mapping, and extracellular volume) results for USUBJID 301. For brevity, after contrast only one of each test was a limited sample of tests were shown in this example.
The PR dataset shows the procedure of cardiac magnetic resonance imaging using the device associated with SPDEVID ABC001 and the PRREFID of 12345678. This information shows what CMR device is used for the procedure and the accession number or procedure reference identifier associated with the specific procedure for USUBJID 301.
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRSTDTC |
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| 1 | DMD-RT | PR | 301 | ABC001 | 1 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING | 2023-08-01 |
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Rows 1-10: | Show the T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart prior to contrast for CMR. | Rows 11-13: | Show the T1 Longitudinal Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart after contrast for CMR. |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBFXL | VISITNUM | VISIT | CVDTC |
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| 1 | DMD-RT | CV | 301 | 1 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | | 1315 | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 2 | DMD-RT | CV | 301 | 2 | T1 | LONGITUDINAL RELAXATION TIME | Pre-contrast | 1166 | ms | 1166 | 1166 | ms | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 3 | DMD-RT | CV | 301 | 3 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | | 980 | ms | LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 4 | DMD-RT | CV | 301 | 4 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 45 | 45 | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 5 | DMD-RT | CV | 301 | 5 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 40 | 40 | ms | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 6 | DMD-RT | CV | 301 | 6 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 48 | 48 | ms | LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 7 | DMD-RT | CV | 301 | 7 |
| NATIVE T1 MAPPING | Pre-contrast | 1070 | ms | | 1070 | ms |
| CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 8 | DMD-RT | CV | 301 | 8 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.5 | /s | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 9 | DMD-RT | CV | 301 | 9 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.2 | /s | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 10 | DMD-RT | CV | 301 | 10 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.1 | /s | LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 11 | DMD-RT | CV | 301 | 11 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | 450 | 450 | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 12 | DMD-RT | CV | 301 | 12 |
| NATIVE T1 MAPPING | Post-contrast | 840 | ms | | 840 | ms |
| CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 | | 13 | DMD-RT | CV | 301 | 13 | EXTRAVOL | EXTRACELLULAR VOLUME | | | % | 25 | 25 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-LGE | AG | 301 | 1 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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DI holds the device identifier information that describes the device used to produce the image that was the basis of the interpretation recorded in the CV domain. Characteristics in DI are those necessary to identify each device to the level of granularity necessary for the study (e.g., to the model level if knowing the actual unit is not necessary, to the serial number level if there is a need to distinguish among units).
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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1 | DMD-LGE | DI | ABC001 | 1 | DEVTYPE | Device Type | CMR Scanner | 2 | DMD-LGE | DI | ABC001 | 2 | MANUF | Manufacturer | ACME | 3 | DMD-LGE | DI | ABC001 | 3 | TRADENAM | Trade Name | ACME 64 | 4 | DMD-LGE | DI | ABC001 | 4 | MODEL | Model Number | CMR540 |
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Fixed properties of devices identified in DI are represented in the DO domain. The sponsor chose to keep the software version constant throughout the study. DO should contain properties that are important for interpreting the data.
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| Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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| 1 | DMD-LGE | DO | ABC002 | | SFTWRNAM | Software Name | CMRRLXU2 |
| | 2 | DMD-LGE | DO | ABC002 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| | 3 | DMD-LGE | DO | ABC002 | 3 | IMAQDIM | Image Acquisition Dimensionality | 3 |
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Changeable properties and parameters of the devices identified in DI are represented in the DU domain. These settings could be linked to the record in the CV domain by their shared SPDEVID and DTC values. For the sake of brevity, only 1 subject's parameters are shown. For more information on relating records, see SDTMIG v3.4 Section 8.2, Relating Peer Records.
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DUSEQ | DUREFID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU | DUDTC |
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| 1 | DMD-LGE | DU | 301 | ABC001 | 1 | 12345678 | ANTPLANE | Anatomical Plane | SAGITTAL |
| SAGITTAL |
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| 2020-02-21 | | 2 | DMD-LGE | DU | 301 | ABC001 | 2 | 12345678 | INTDISTM | | 1 | mm | 1 | 1 | mm | 2020-02-21 | | 3 | DMD-LGE | DU | 301 | ABC001 | 3 | 12345678 | STHICK | Slice Thickness | 1 | mm | 1 | 1 | mm | 2020-02-21 | | 4 | DMD-LGE | DU | 301 | ABC001 | 4 | 12345678 | PIXSPCX | X-axis Pixel Spacing | 2 | mm | 2 | 2 | mm | 2020-02-21 | | 5 | DMD-LGE | DU | 301 | ABC001 | 5 | 12345678 | PIXSPCY | Y-axis Pixel Spacing | 2 | mm | 2 | 2 | mm | 2020-02-21 | | 6 | DMD-LGE | DU | 301 | ABC001 | 6 | 12345678 | AQMTRXSZ | Image Acquisition Matrix Size | 256X256 | VOXEL | 256X256 | 256X256 | VOXEL | 2020-02-21 | | 7 | DMD-LGE | DU | 301 | ABC001 | 7 | 12345678 | FLDVIEW | Field of View | 280X280 | mm | 280X280 | 280X280 | mm | 2020-02-21 | | 8 | DMD-LGE | DU | 301 | ABC001 | 8 | 12345678 | NUMSLICE | Number of Slices | 125 |
| 125 | 125 |
| 2020-02-21 | | 9 | DMD-LGE | DU | 301 | ABC001 | 9 | 12345678 | ATTCRCT | Attenuation Correction Type | FBP |
| FBP |
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| 2020-02-21 | | 10 | DMD-LGE | DU | 301 | ABC001 | 10 | 12345678 | DECCORR | Decay Correction Indicator | N |
| N |
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| 2020-02-21 | | 11 | DMD-LGE | DU | 301 | ABC001 | 11 | 12345678 | RANDCORR | Randoms Correction Indicator | N |
| N |
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| 2020-02-21 | | 12 | DMD-LGE | DU | 301 | ABC001 | 12 | 12345678 | RECONDAT | Reconstruction of Raw Data Type | ITERATIVE |
| ITERATIVE |
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| 2020-02-21 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-LGE | PR |
| PRLNKID |
| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
| AGLNKID |
| ONE | 04 |
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