The procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. The example PR dataset below shows the cardiac magnetic resonance imaging with two different MRI machines. The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset below.
Row 1:
Shows the results of a cardiac MRI for participant DMD-LGE-01-201.
Row 2:
Shows the results 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.
pr.xpt
pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
SPDEVID
PRREFID
PRLNKID
PRTRT
PRLOC
PRFAST
PRSTDTC
1
DMD-LGE
PR
DMD-LGE-01-201
1
ABC001
12345678
04
MRI
HEART
Y
2023-07-01T09:15:00
2
DMD-LGE
PR
DMD-LGE-01-202
1
ABC002
98765432
05
MRI
HEART
N
2023-07-05
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
The example CV dataset below 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). (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 CVANMETH variable.
Row 1:
Shows that LGE is positive for participant DMD-LGE-01-201.
Row 2:
Shows the total LGE percentage is 40%.
Rows 3-19:
Show the 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-01-202.
The procedure agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. The example AG dataset below shows the timing of the gadolinium-based contrast, 'Gd-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.
ag.xpt
ag.xpt
Row
STUDYID
DOMAIN
USUBJID
AGSEQ
AGLNKID
AGTRT
AGCAT
AGDOSE
AGDOSU
AGDOSFRM
AGROUTE
VISITNUM
AGSTDTC
1
DMD-EFLGE
AG
DMD-LGE-01-201
1
04
Gd-DOTA
CONTRAST AGENT
8
mL
SOLUTION
INTRAVENOUS
VISIT 1
2023-07-01T09:25:00
2
DMD-EFLGE
AG
DMD-LGE-01-202
2
04
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 two 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 one record or row for each device.