This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to late gadolinium enhancement.
The Procedures (PR) dataset is an interventions domain that represents domain 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 MR MRI machines. The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset.
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Row 1: | Shows the procedure of a cardiac MRI for participant DMD-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-LGE | PR | DMD-LGE-01-201 | 1 | ABC0011 | 12345678 | 04 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | Y | 2023-07-01T09:15:00 | 2 | DMD-LGE | PR | DMD-LGE-01-202 | 1 | ABC0021 | 98765432 | 05 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | N | 20202023-07-0205 |
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This 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 variableThe Cardiovascular System Findings (CV) dataset contains 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 dataset.
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Row 1: | Shows the late gadolinium enhancement (that LGE ) is positive for the overall Left Ventricle for participant DMD-LGE-01-201. | Row 2: | Shows the late gadolinium enhancement (LGE) overall Left Ventricle total LGE percentage is 40% for participant 201. | Rows 3-1819: | Shows Show the segmental late gadolinium enhancement (LGE) values LGE results for each of the left ventricle segments for participant 201. | Row 1920: | Shows the total late gadolinium enhancement (LGE) positive segments for participant 201LGE segment count. | Rows 2021-2324: | Shows Show the segmental late gadolinium enhancement ( LGE ) percentage for each of the positive LGE segments for participant 201. | Row 725: | 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-LGE | CV | DMD-LGE-01-201 | 1 | 04 | LGELATE GADOLINIUM ENHANCEMENT | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUALCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2 | DMD-LGE | CV | DMD-LGE-01-201 | 2 | 04 | TLGEPR | LGEPER | Late Gadolinium Enhancement PercentageTOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE | | % | | 40 | % | HEART, LEFT VENTRICLE | MRI |
| QUANTITATIVECARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 3 | DMD-LGE | CV | 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 | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 4 | DMD-LGE | CV | 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 | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 5 | DMD-LGE | CV | DMD-LGE-01-201 | 5 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 6 | DMD-LGE | CV | DMD-LGE-01-201 | 6 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 7 | DMD-LGE | CV | DMD-LGE-01-201 | 7 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 8 | DMD-LGE | CV | DMD-LGE-01-201 | 8 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR ANTEROLATERAL SEGMENTBASAL INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 9 | DMD-LGE | CV | DMD-LGE-01-201 | 9 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 10 | DMD-LGE | CV | DMD-LGE-01-201 | 10 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 11 | DMD-LGE | CV | DMD-LGE-01-201 | 11 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 12 | DMD-LGE | CV | DMD-LGE-01-201 | 12 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 13 | DMD-LGE | CV | DMD-LGE-01-201 | 13 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 14 | DMD-LGE | CV | DMD-LGE-01-201 | 14 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 15 | DMD-LGE | CV | DMD-LGE-01-201 | 15 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 16 | DMD-LGE | CV | DMD-LGE-01-201 | 16 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 17 | DMD-LGE | CV | DMD-LGE-01-201 | 17 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 18 | DMD-LGE | CV | DMD-LGE-01-201 | 18 | 04 | SGTLGE | SGELGE | Segmental Late Gadolinium EnhancementSEGMENTAL LATE GADOLINIUM ENHANCEMENT | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01CARDIAC MAGNETIC RESONANCE IMAGING | 19 | DMD-LGE | CV | 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 | MRI |
| VISUALCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2021 | DMD-LGE | CV | DMD-LGE-01-201 | 2021 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 40 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUMCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2122 | DMD-LGE | CV | DMD-LGE-01-201 | 2122 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUMCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2223 | DMD-LGE | CV | DMD-LGE-01-201 | 2223 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 45 | % | LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUMCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2324 | DMD-LGE | CV | DMD-LGE-01-201 | 2324 | 04 | LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | % | | 20 | % | LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| FULL-WIDTH HALF MAXIMUMCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-01 | 2425 | DMD-LGE | CV | DMD-LGE-01-202 | 1 | 0405 | LGELATE GADOLINIUM ENHANCEMENT | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUALCARDIAC MAGNETIC RESONANCE IMAGING | 1SCREENING | VISIT 1 | 2023-07-0105 |
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The Procedure Agent Agents (AG) dataset is an interventions domain that 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 gadolinium-based contrast, GDGd-DOTA. Participant 202 did not have the 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-LGE | AG | DMD-LGE-01-201 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-01T0801T09:4525:00 | 2 | DMD-LGE | 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 |
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| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
| AGLNKID |
| ONE | 04 |
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