Late Gadolinium Enhancement (LGE) is an assessment made with CMR imaging that includes gadolinium contrast administration. The test is done to assess for gadolinium contrast material accumulation in the tissue with increased extracellular space to determine both left and right ventricle fibrosis (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801263/). For LGE, the assessment relates to the timing of the reading showing whether or not the contrast is present or not at the specific time of the reading (would be determined by the protocol but typically is noted approximately 10 minutes after contrast injection). If the LGE is noted as present, more assessments may be done such as presence per segment and the percentage of presence per segment.
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 machinesMRI 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 subject participant DMD-LGE-01-201. | Row 2: | Shows the procedure of a cardiac MRI for subject 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 | SPDEVIDPRSEQ | PRREFID | PRLNKID | PRTRT | PRLOC | PRFAST | PRSTDTC |
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1 | DMD-LGE | PR | DMD-LGE-01-201 | 1 | ABC0011 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING | MRI | HEARTCARDIAC WALL | Y | 2023-07-01T0801T09:5515:00 | 2 | DMD-LGE | PR | DMD-LGE-01-202 | 1 | ABC0021 | 98765432 | 05 | CARDIAC MAGNETIC RESONANCE IMAGING | MRI | HEARTCARDIAC WALL | N | 20202023-07-02T10:05:00 |
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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.
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Row 1: | Shows that LGE is positive for participant DMD-LGE-01-201. | Row 2: | Shows the total LGE percentage is 40%. | Rows 3-19Rows 1-5: | Show the late gadolinium enhancement (LGE) is present and affecting 4 segments with corresponding percentage for each segment for subject 201.segmental LGE results for each of the left ventricle segments. | Row 20: | Shows the LGE segment count. | Rows 21-24: | Show the segmental LGE percentage for each of the positive segments. | Row 25: | Shows that LGE is negative for participant DMD-LGE-01- | Row 6: | Shows the late gadolinium enhancement (LGE) is absent for subject 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 |
LATE GADOLINIUM ENHANCEMENT | | | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | LGE | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 2 | DMD-LGE | CV | DMD-LGE-01-201 | 2 | 04 | LGEPER | Late Gadolinium Enhancement Percentage | | % | | 40 | % | HEART, LEFT VENTRICLE | MRI |
| QUANTITATIVE | 1 | VISIT 1 | 2023-07-01 | 3 | DMD-LGE | CV | DMD-LGE-01-201 | 3 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | NEGATIVE |
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| LEFT VENTRICULAR BASAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 4 | DMD-LGE | CV | DMD-LGE-01-201 | 4 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 5 | DMD-LGE | CV | DMD-LGE-01-201 | 5 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 6 | DMD-LGE | CV | DMD-LGE-01-201 | 6 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 7 | DMD-LGE | CV | DMD-LGE-01-201 | 7 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 8 | DMD-LGE | CV | DMD-LGE-01-201 | 8 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 9 | DMD-LGE | CV | DMD-LGE-01-201 | 9 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 10 | DMD-LGE | CV | DMD-LGE-01-201 | 10 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 11 | DMD-LGE | CV | DMD-LGE-01-201 | 11 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 12 | DMD-LGE | CV | DMD-LGE-01-201 | 12 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 13 | DMD-LGE | CV | DMD-LGE-01-201 | 13 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID INFEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 14 | DMD-LGE | CV | DMD-LGE-01-201 | 14 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 15 | DMD-LGE | CV | DMD-LGE-01-201 | 15 | 04 | LATE GADOLINIUM ENHANCEMENT (# of segments) | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL ANTERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 16 | DMD-LGE | CV | DMD-LGE-01-201 | 16 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL SEPTAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 17 | DMD-LGE | CV | DMD-LGE-01-201 | 17 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL INFERIOR SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 18 | DMD-LGE | CV | DMD-LGE-01-201 | 18 | 04 | SGELGE | Segmental Late Gadolinium Enhancement | |
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| LEFT VENTRICULAR APICAL LATERAL SEGMENT | MRI |
| VISUAL | 1 | VISIT 1 | 2023-07-01 | 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 | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | SCREENING321 | DMD-LGE | CV | DMD-LGE-01-201 | 3LATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | 20202040 | % | LEFT VENTRICULAR BASAL | ANTERIOR CARDIAC MAGNETIC RESONANCE IMAGING | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | SCREENING422 | DMD-LGE | CV | DMD-LGE-01-201 | 4LATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | 30303020 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | SCREENING523 | DMD-LGE | CV | DMD-LGE-01-201 | 5LATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage | | % | | 45 | % | LEFT VENTRICULAR MID | INFERIOR CARDIAC MAGNETIC RESONANCE IMAGING | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | SCREENING524 | DMD-LGE | CV | DMD-LGE-01-201 | 6LATE GADOLINIUM ENHANCEMENT PERCENTAGE | Late Gadolinium Enhancement Percentage | | 505050RIGHT INFERIOR CARDIAC MAGNETIC RESONANCE IMAGING | MRI |
| FULL-WIDTH HALF MAXIMUM | 1 | SCREENING125 | DMD-LGE | CV | DMD-LGE-01-202 | 1 | 05 |
LATE GADOLINIUM ENHANCEMENT | | | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | LGE | Late Gadolinium Enhancement | |
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| HEART, LEFT VENTRICLE | MRI |
| VISUAL | 1 | VISIT 1 | SCREENING01 |
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The Procedure Agent Agents (AG) dataset is an interventions domain that contains the agents administered to the subject as part of a procedure or assessment. The This example AG dataset shows the timing of the Gadolinium 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-LGE | AG | DMD-LGE-01-201 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-01T0801T09:4525:00 | 12 | DMD-LGE | AG | DMD-LGE-01-202 | 12 | 05 | Gd-DOTA | CONTRAST AGENT | 10 | mL | SOLUTION | INTRAVENOUS | VISIT 1 | 2023-07-05T09:55:00-05 |
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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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