This example 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 requirements will determine what level of granularity is needed.
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 variable SPDEVID 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.
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
PRFAST
PRSTDTC
1
DMD-EFLGE
PR
DMD-LGE-01-201
1
ABC001
12345678
04
CARDIAC MAGNETIC RESONANCE IMAGING
Y
2023-07-01T09:15:00
2
DMD-EFLGE
PR
DMD-LGE-01-202
1
ABC002
98765432
05
CARDIAC MAGNETIC RESONANCE IMAGING
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 showsthe results of the LGE test measured using cardiac magnetic resonance (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-EFLGE-01-101.
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-EFLGE-01-202.
The procedure agents (AG) domain contains the agents administered to the 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-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.
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 DI Sequence number (DISEQ) is specific to each device; note there are two different CMR Scanners each with different identifiers in the Sponsor Device Identifier (SPDEVID) variable and each have a value of "1" for the DISEQ variable. The reason because there is only one record or row for each device.