This example dataset shows the findings of a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. Different levels of granularity are shown with the various tests and details that might be represented. The research requirements will determine what level of granularity is needed. For example, a study using LGE may require LGE test in their data without the detail of 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 of "Full-width half maximum" which is one of the types of analysis that may be done. The example provides how to represent this type of information if the researchers are interested in this type of information for the study data.
LGE assessments may be done on each of the cardiovascular segments as shown in Figure 1. https://www.ahajournals.org/doi/full/10.1161/hc0402.102975.
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Figure 1. Left Ventricular Segments | Figure 1. Left Ventricular Segments | This example includes example datasets to reflect how the CMR procedure and the contrast would be represented in the data.The Procedures (PR) domain
represents contains interventional activity intended to have diagnostic, preventive,
and therapeutic
activity. The , or palliative effects. This example PR dataset shows the
cardiac magnetic resonance CMR imaging with
two 2 different MRI machines
, using the SPDEVID . The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset
below. The ANMETH variable describes 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) which in this case applies to the CMR imaging.
TO DO - Describe the analysis method for LGE - three different methods:
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Row 1: | Shows the procedure of a cardiac MRI for participant 101DMD-LGE-01-201. | Row 2: | Shows the procedure of a cardiac MRI for participant DMD-LGE-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 | PRLOC | PRFAST | PRSTDTC |
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1 | DMD-EFLGELGE | PR | DMD-LGE-01-201 | 1 101 | ABC0011 | 12345678 | 04 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | Y | 2023-07-01T09:15:00 | 2 | DMD-EFLGELGE | PR | DMD-LGE-01-202 | 1 | ABC002 | 1 | 98765432 | 05 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | N | 2023-07-05 |
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The Cardiovascular System Findings (CV) domain represents physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. The findings from the CMR procedure for LGE are noted in this example. If LGE was not performed, it would not appear in the datasetThis example CV dataset shows the results of the LGE test measured using 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).[7] If this information is of interest to the study, it would be represented using the CVANMETH variable.
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Row 1: | Shows the late gadolinium enhancement (that LGE ) is positive for the overall Left Ventricle for participant 101participant DMD-LGE-01-201. | Row 2: | Shows the late gadolinium enhancement (LGE) overall Left Ventricle total LGE percentage is 40% for participant 101. | Rows 3-1819: | Show the segmental late gadolinium enhancement (LGE) values LGE results for each of the left ventricle segments for participant 101. | Row 1920: | Shows the total late gadolinium enhancement (LGE) positive segments for participant 101LGE segment count. | Rows 2021-2324: | Show the segmental late gadolinium enhancement ( LGE ) percentage for each of the positive LGE segments for participant 101. | Row 2425: | Shows the late gadolinium enhancement (that LGE ) is negative for participant DMD-LGE-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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 2 | 04 | TLGEPR | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 4 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 5 | DMD-EFLGELGE | CV101 | DMD-LGE-01-201 | 5 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 6 | DMD-EFLGELGE | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 8 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL ANTEROLATERAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 9 | DMD-EFLGELGE | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 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 | CV101 | DMD-LGE-01-201 | 19 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APEX SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 20 | DMD-LGE | CV | DMD-LGE-01-201 | 20 | 04 | LGESEGCT | Late Gadolinium Enhancement Segment Ct | TLGE | TOTAL LGE SEGMENTS | |
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| HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 2021 | DMD-EFLGELGE | CV | 101 | DMD-LGE-01-201 | 2120 | 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 | 2122 | DMD-EFLGELGE | CV | 101 | DMD-LGE-01-201 | 2221 | 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 | 2223 | DMD-EFLGELGE | CV | 101 | DMD-LGE-01-201 | 2322 | 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 | 2324 | DMD-EFLGELGE | CV | 101 | DMD-LGE-01-201 | 2423 | 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 | 2425 | DMD-EFLGELGE | CV | DMD-LGE-01-202 | 1 | 0405 | 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 Agent Agents (AG) represents domain contains the agents administered to the participant subject as part of a procedure or assessment. The This example AG dataset shows the timing of the gadolinium-based contrast, GDGd-DOTA. The time the contrast was given to participant DMD-LGE-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 | AG101 | DMD-LGE-01-201 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-01T09:25:00 | 2 | DMD-EFLGELGE | AG | DMD-LGE-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 |
| PRLNKID |
| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
| AGLNKID |
| ONE | 04 |
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