This example shows the findings of a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. The level of granularity varies with the type of test used; research requirements will determine what level of granularity is needed. For example, a study may not include the analysis method. Alternatively, researchers may be interested in understanding if the assessments were done visually or with quantitative methods. If the study includes an assessment of each segment, such as with the Segmental Late Gadolinium Enhancement Percentage, there may be interest in representing the quantitative analysis method. (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-16-45)
The procedures (The Procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. The This example PR dataset below shows the cardiac magnetic resonance CMR imaging with two 2 different MRI machines. The sponsor device identifier (SPDEVID) variable SPDEVID is used to represent the imaging device identifier information provided in the DI dataset below. For more information on this domain, see Section 6.1.5, Procedures (PR), in the SDTMIG v3.4.
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Row 1: | Shows the results procedure of a cardiac MRI for participant DMD-EFLGELGE-01-101201. | Row 2: | Shows the results procedure of a cardiac MRI for participant DMD-EFLGELGE-01-202 with a different MRI machine. The time of the procedure was not available, so only the date is shown in the PRSTDTC variable. |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | SPDEVID | PRREFID | PRLNKID | PRTRT | PRLOC | PRFAST | PRSTDTC |
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1 | DMD-EFLGELGE | PR | DMD-EFLGELGE-01-101201 | 1 | ABC001 | 12345678 | 04 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | Y | 2023-07-01T09:15:00 | 2 | DMD-EFLGELGE | PR | DMD-EFLGELGE-01-202 | 1 | ABC002 | 98765432 | 05 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | N | 2023-07-05 |
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The This example CV dataset below shows the results of the LGE test measured using cardiac magnetic resonance ( CMR ) imaging. The analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). There may be machine-centric analysis methods inherit to the type of machine (e.g., full-width half maximum, 5 standard deviations, 6 standard deviations). (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-12-21). If [7] If this information is of interest to the study, it would be represented using the ANMETH CVANMETH variable.
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Row 1: | Shows the late gadolinium enhancement that LGE is positive for participant DMD-EFLGELGE-01-101201. | Row 2: | Shows the total late gadolinium enhancement LGE percentage is 40%. | Rows 3-19: | Show the segmental late gadolinium enhancement LGE results for each of the left ventricle segments. | Row 20: | Shows the late gadolinium enhancement LGE segment count. | Rows 21-24: | Show the segmental late gadolinium enhancement LGE percentage for each of the positive segments. | Row 25: | Shows the late gadolinium enhancement that LGE is negative for participant DMD-EFLGELGE-01-202. |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBFXL | CVANMETH | VISITNUM | VISIT | CVDTC |
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1 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 1 | 04 | LGELATE GADOLINIUM ENHANCEMENT | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 2 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 2 | 04 | TLGEPER | LGEPER | Late Gadolinium Enhancement PercentageTOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 40 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| QUANTITATIVE | 1 | VISIT 1 | 2023-07-01 | 3 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 3 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium Enhancement SEGMENTAL LATE GADOLINIUM ENHANCEMENT | NEGATIVE |
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| LEFT VENTRICULAR BASAL ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 4 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 4 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 5 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 5 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 6 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 6 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 7 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 7 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 8 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 8 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 9 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 9 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 10 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 10 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 11 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 11 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 12 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 12 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 13 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 13 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 14 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 14 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 15 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 15 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 16 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 16 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 17 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 17 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 18 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 18 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 19 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 19 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APEX SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 20 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 20 | 04 | LGESEGC | LGESEGCT | Late Gadolinium Enhancement Segment Ct LATE GADOLINIUM ENHANCEMENT SEGMENT COUNT | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 21 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 21 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 40 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 22 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 22 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 23 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 23 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 45 | % | LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 24 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-101201 | 24 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | 25 | DMD-EFLGELGE | CV | DMD-EFLGELGE-01-202 | 1 | 05 | LGELATE GADOLINIUM ENHANCEMENT | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-05 |
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The procedure agents Procedure Agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. For more information on this domain, see Section 6.1.1, Procedure Agents (AG), in the SDTMIG v3.4.The This example AG dataset below shows the timing of the gadolinium-based contrast, ' Gd-DOTA'. The time the contrast was given to participant DMD-EFLGELGE-01-202 was not available, so only the date is represented in AGSTDTC variable.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGLNKID | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | VISITNUM | AGSTDTC |
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1 | DMD-EFLGELGE | AG | DMD-EFLGELGE-01-101201 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-01T09:25:00 | 2 | DMD-EFLGELGE | AG | DMD-EFLGELGE-01-202 | 2 | 0405 | Gd-DOTA | CONTRAST AGENT | 10 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-05 |
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The Device Identifiers (DI) domain is used to represent the device information details. For this particular example, the device type was the only detail of interest to the researchers. The sequence number (DISEQ) is specific to each device; note there are 2 different CMR scanners noted with different values in the SPDEVID variable. Each scanner has a value of "1" for the DISEQ variable since there is only 1 record or row for each device.
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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 | ABC002 | 1 | DEVTYPE | Device Type | CMR Scanner |
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The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-LGE | PR |
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| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
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| ONE | 04 |
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