The example shows the representation of device information, such as the CMR device manufacturer, software and version information, and the specific settings for each subject. Study requirements determine what data is needed. This examples shows how to do it, if it is desired. https://www.sciencedirect.com/science/article/pii/S1936878X15008670?via%3Dihub, https://www.ahajournals.org/doi/10.1161/circresaha.116.307974
The example The PR dataset shows the procedure of cardiac magnetic resonance imaging using the device associated with SPDEVID ABC001 and the PRREFID of 12345678cardiac MRI. The device identifier data is represented using SPDEVID and PRREFID. 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 subject DMD-RT-01-301. The SPDEVID variable is was used to relate this PR dataset to other records by the device (in this case, the CMR machine). The Device Identifier (DI) domain represents the device information details, the Device Properties (DO) domain represents characteristics of the device that do not vary between subjects. The Device-In-Use (DU) domain represents settings that are set on a device when it is used and may vary between participants.
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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 Cardiovascular System Findings (CV) domain represents physiological and morphological findings related to the cardiovascular system so it holds the assessments from the parametric mapping. The example 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 noted using the CVTPT to note if the CVTEST was done before or after contrast. CVTPTREF associates the timepoints in CVTPT with "contrast administration." In the example below, row 9 shows an unreadable CMR using the CVSTAT variable This example includes records for an unreadable image and an unperformed test. CVSTAT was populated with "NOT DONE" and the CVREASND variable shows was populated with the reason the procedure result was not done, provided or in this case the result not provided which was a non-evaluable image. A similar approach may be used if there is a desire to record that the CMR was not obtained at the specific visit (omitting the poor-quality information) and why in the dataset recordsthe procedure was not done. The non-standard variable CVOIQ = Cardiovascular Overall Image Quality is used to represent if the image for the evaluation is "non-evaluable", "evaluable", "evaluable Image - sub-optimal", or "evaluable image - optimal"image quality.
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Rows 1-6: | Show the T1 Longitudinal Relaxation Time, and the T2 Transverse Relaxation Time, (Native T1 Mapping) longitudinal relaxation time and the transverse relaxation time for different segments of the heart prior to contrast for CMR. | Rows 7-8: | Show the T1 Longitudinal Relaxation Time, Native T1 Mapping, and Extracellular longitudinal relaxation time and myocardial extracellular volume for different segments of the heart after contrast for CMR. | Row 9: | Shows an unreadable CMR result for participant 302 had a CMR procedure that was unreadableDMD-RT-01-302, CVREASND = "NON-EVALUABLE ". This is denoted by CVTESTCD = "CARDIOVASCULAR SYSTEM FINDINGS" and CVMETHOD = "CARDIAC MAGNETIC RESONANCE IMAGING"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 AG dataset shows the Gadolinium gadolinium based contrast that was used for the procedure. In this example, the researchers did not collect the time of the contrast.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-RT | AG | DMD-RT-01-301 | 1 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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The device identifiers (DI) domain represents is used to represent 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 information details. Characteristics recorded in a DI dataset 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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Changeable properties and parameters of devices 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 brevity, only 1 subject's parameters are shown. For For more information on relating records, see SDTMIG v3.4 Section 8.2, Relating Peer Records.
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