This example dataset 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 ; 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. This example illustrates how to represent this type of information. (Ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-16-45)
The procedures (PR) domain is used to represent contains interventional activity intended to have diagnostic, preventive, and therapeutic activity, or palliative effects. The example PR dataset below shows the cardiac magnetic resonance imaging with two different MRI machines. The variable SPDEVID represents 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 of a cardiac MRI for participant DMD-EFLGE-01-101. | Row 2: | Shows the results of a cardiac MRI for participant DMD-EFLGE-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 | PRSEQ | PRREFID | PRLNKID | PRTRT | PRFAST | PRSTDTC |
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| 1 | DMD-EFLGE | PR | DMD-EFLGE-01-101 | 1 | ABC001 | 1 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING | Y | 2023-07-01T09:15:00 | | 2 | DMD-EFLGE | PR | DMD-EFLGE-01-202 | 1 | ABC0021 | 98765432 | 05 | CARDIAC MAGNETIC RESONANCE IMAGING | N | 2023-07-05 |
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The cardiovascular system findings (CV) dataset example CV dataset below shows the results of the LGE test measured using cardiac magnetic resonance (CMR) imaging.
The CVANMETH variable is used to represent the analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence). There are 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 this information is of interest to the study, it would be represented using the ANMETH variable.
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Row 1: | Shows the late gadolinium enhancement is positive for participant DMD-EFLGE-01-101. | Row 2: | Shows the total late gadolinium enhancement percentage is 40%. | Rows 3-19: | Show segmental late gadolinium enhancement results for each of the left ventricle segments. | Row 20: | Shows the late gadolinium enhancement segment count. | Rows 21-24: | Show the segmental late gadolinium enhancement percentage for each of the positive segments. | Row 25: | Shows the late gadolinium enhancement is negative for participant DMD-EFLGE-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-EFLGE | CV | DMD-EFLGE-01-101 | 1 | 04 | LGE | LATE GADOLINIUM ENHANCEMENT | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 2 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 2 | 04 | TLGEPER | TOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 40 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING |
| QUANTITATIVE | 1 | VISIT 1 | 2023-07-01 | | 3 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 3 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | NEGATIVE |
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| LEFT VENTRICULAR BASAL ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 4 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 4 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 5 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 5 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 6 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 6 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 7 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 7 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 8 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 8 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 9 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 9 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 10 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 10 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 11 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 11 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 12 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 12 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 13 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 13 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 14 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 14 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 15 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 15 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 16 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 16 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 17 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 17 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 18 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 18 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 19 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 19 | 04 | SGTLGE | SEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APEX SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 20 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 20 | 04 | LGESEGC | LATE GADOLINIUM ENHANCEMENT SEGMENT COUNT | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | | 21 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 21 | 04 | LGEPER | LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 40 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 22 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 22 | 04 | LGEPER | LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 20 | % | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 23 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 23 | 04 | LGEPER | LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 45 | % | LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 24 | DMD-EFLGE | CV | DMD-EFLGE-01-101 | 24 | 04 | LGEPER | LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 20 | % | LEFT VENTRICULAR INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| FULL-WIDTH HALF MAXIMUM | 1 | VISIT 1 | 2023-07-01 | | 25 | DMD-EFLGE | CV | DMD-EFLGE-01-202 | 1 | 05 | LGE | LATE GADOLINIUM ENHANCEMENT | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING |
| VISUAL | 1 | VISIT 1 | 2023-08-05 |
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The procedure agents (AG) domain represents contains the agents administered to the participant 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 example AG dataset below shows the timing of the gadolinium-based contrast, GD'Gd-DOTA'. The time the contrast was given to participant DMD-EFLGE-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-EFLGE | AG | DMD-EFLGE-01-101 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS |
| 2023-07-01T09:25:00 | 2 | DMD-EFLGE | AG | DMD-EFLGE-01-202 | 2 | 04 | Gd-DOTA | CONTRAST AGENT | 10 | mL | SOLUTION | INTRAVENOUS |
| 2023-07-05 |
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