This example Procedures (PR) dataset includes the SPDEVID variable to show what device was used and the PRREFID variable to represent the accession number or procedure reference identifier associated with the specific procedure. SPDEVID was used to link this PR record to the device records.
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRLOC | PRSTDTC |
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| 1 | DMD-RT | PR | DMD-RT-01-301 | ABC001 | 1 | 12345678 | 04 | MRI | HEART | 2023-08-01 |
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This example cardiovascular system findings (CV) dataset shows how to represent longitudinal relaxation time, transverse relaxation time, and extracellular volume findings from CMR imaging. This example includes records for an unreadable image and an unperformed test. For these records, CVSTAT was populated with "NOT DONE" and CVREASND was populated with the reason the result was not provided or the procedure was not done. An NSV was used to represent image quality
"T1 mapping stands for registering the course of recovery of longitudinal magnetism", this means the relaxation time after either the preparation step (saturation or inversion prepulse) followed by the acquisition of images at several time points during the T1 recover/relaxation. T1 value represents the time when recovery of magnetism has reached a percentage of its original state (63%). The recovery rate relates to the myocardial tissue properties that may be altered by pathological tissue presence (https://www.ahajournals.org/doi/10.1161/circresaha.116.307974). T1 mapping values increase with disease, and decrease post contrast.
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- What is the difference between T1 and T2? Should there be any differences in the data collected for each of these?
- Do we need minimum and maximum values? for SI mean, area, circumference, SI mean, SI min/max?
- Do we need timepoints for the T1 measurement or just the point in time of the final assessment?
- Does Cardiac Motion correction need to be indicated? If yes, does the type need to be indicated (such as the modified LL (MOLLI) sequence)? If yes, should this be reflected on each result? (Alana/Jon/Diane - I am considering a "Cardiac Motion Correction Indicator" NSV)
- Do we need a postcontrast indicator since those measurement differ? or is that what the terms "native T1" (no contrast) and "post-contrast T1" (after contrast) mean?
- Three is a "gold" standard noted as the "T1 mapping based on the acquisition of single images by a T1 turbo spin-echo sequence". It is noted as the ultimate T1 mapping method. Does the method need to be called out by what kind of acquisition sequence was used?
- For the location does the intracellular compartment need to be noted? (myocytes, fibroblasts, endothelial cells, smooth muscle cells)
- Does the cardiac phase for the specific T1 segment need to be noted? (atrial systole-diastole; isovolumentric contraction-diastole; rapid ejection-systole; reduced ejection-systole; isovolumetric relaxation-diastole; rapid ventricular filling-diastole)
- Is it important to record the "MRI scanner type" (Avanto, Siemens; Best, Philips; Acheiva, Philips), the "reception coil" (16-channel; 32-channel), "the T1 mapping sequence" (MOLLI; ShMOLLI)
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The following example shows the T1 mapping results for USUBJID 301. For brevity, after contrast only one of each test was shown in this example.
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Rows 1-106: | Show the T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume longitudinal relaxation time and the transverse relaxation time for different segments of the heart prior to contrast for CMR(CVTPT = BEFORE and CVTPTREF = CONTRAST ADMINISTRATION). | Rows 117-148: | Show the T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart after contrast for CMRlongitudinal relaxation time and myocardial extracellular volume for the LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT after contrast (CVTPT = AFTER and CVTPTREF = CONTRAST ADMINISTRATION). | 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 | CVLNKID | CVTESTCD | CVTEST |
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CVCAT | 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 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | | | Longitudinal Relaxation Time | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 2 | DMD-RT | CV | DMD-RT-01-301 | 2 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | Pre-contrast | | Longitudinal Relaxation Time | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 3 | DMD-RT | CV | DMD-RT-01-301 | 3 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | | | Longitudinal Relaxation Time | | ms | | 980 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 4 | DMD-RT | CV | DMD-RT-01-301 | 4 | 04 | T2 |
TRANSVERSE RELAXATION TIME | | 962| Transverse Relaxation Time | | ms |
962962| 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 5 | DMD-RT | CV | DMD-RT-01-301 | 5 | 04 | T2 |
TRANSVERSE RELAXATION TIME | | | ms | | | Transverse Relaxation Time | | ms | 40 | 40 |
976 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 6 | DMD-RT | CV | DMD-RT-01-301 | 6 | 04 | T2 |
TRANSVERSE RELAXATION TIME | | | Transverse Relaxation Time | |
985985985| 48 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 7 | DMD-RT | CV | DMD-RT-01-301 | 7 | 04 |
NATIVE MAPPINGPre-contrast | | Longitudinal Relaxation Time | |
107010701070CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION |
SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 8 | DMD-RT | CV | DMD-RT-01-301 | 8 |
EXTRAVOLEXTRACELLULAR VOLUME | | | /s | | 1.5 | | MYECV | Myocardial Extracellular Volume | | % | 25 | 25 | % |
/s | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING| 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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| | | | MRI |
| 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 | | MRI |
| 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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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGLNKID | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-RT | AG | DMD-RT-01-301 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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The Device Identifiers (DI) domain is used to represent the device 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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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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1 | DMD-RT | DI | ABC001 | 1 | DEVTYPE | Device Type | CMR Scanner | 2 | DMD-RT | DI | ABC001 | 2 | MANUF | Manufacturer | ACME | 3 | DMD-RT | DI | ABC001 | 3 | TRADENAM | Trade Name | ACME 64 | 4 | DMD-RT | DI | ABC001 | 4 | MODEL | Model Number | CMR540 |
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Fixed properties of devices are represented in the Device Properties (DO) domain. The sponsor chose to keep the software version constant throughout the study.
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| Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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| 1 | DMD-RT | DO | ABC001 | | SFTWRNAM | Software Name | CMRRLXU2 |
| | 2 | DMD-RT | DO | ABC001 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| | 3 | DMD-RT | DO | ABC001 | 3 | IMAQDIM | Image Acquisition Dimensionality | 3 |
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Changeable properties and parameters of devices are represented in the Device-in-Use (DU) domain. These settings can be linked to records in the CV dataset by their shared SPDEVID and DTC values. For brevity, only 1 subject's parameters are shown.
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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-RT | DU | DMD-RT-01-301 | ABC001 | 1 | 12345678 | ANTPLAN | Anatomical Plane | SAGITTAL |
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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 | SCREENING11CV | 301 | 11 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | | 1015 | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | DU | DMD-RT-01-301 | ABC001 | 2 | 12345678 | PULSSEQ | Pulse Sequence | SPGR |
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| 2023-08-01 | | 3 | DMD-RT | DU | DMD-RT-01-301 | ABC001 | 3 | 12345678 | FLIPANGL | Flip Angle | 50 | deg | 50 | 50 | deg |
SCREENING12CV | 301 | 12 | T2 | TRANSVERSE RELAXATION TIME | | | ms | | | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | DU | DMD-RT-01-301 | ABC001 | 4 | 12345678 | INTDISTM | | 1 | mm | 1 | 1 | mm | 2023-08-01 | | 5 | DMD-RT | DU | DMD-RT-01-301 | ABC001 | 5 | 12345678 | STHICK | Slice Thickness | 6 | mm | 6 | 6 | mm |
SCREENING13CV | 301 | 13 | NATIVE T1 MAPPING | Post-contrast | 840 | ms | | 840 | ms | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | DU | DMD-RT-01-301 | ABC001 | 6 | 12345678 | FLDVIEW | Field of View | 32X38 | cm | 32X38 | 32X38 | cm | 2023-08-01 | | 7 | DMD-RT | DU | DMD-RT-01-301 | ABC001 | 7 | 12345678 | NUMSLICE | Number of Slices | 12 |
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SCREENING14CV | 301 | 14 | EXTRAVOL | EXTRACELLULAR VOLUME | DU | DMD-RT-01-301 | ABC001 | 8 | 12345678 | COILSTR | Coil Strength |
Post-contrast1/s11/s | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | |
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The AG dataset shows the Gadolinium based contrast that was used for the procedure. In this example, the researchers did not collect the time of the contrast.RELREC dataset is used to describe the relationship between 2 or more records in different domains.
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DOMAINRDOMAIN | USUBJID | IDVAR | IDVARVAL |
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AGSEQAGTRTAGCATAGDOSEAGDOSUAGDOSFRMAGROUTEAGSTDTC1LGEAG3011Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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