"In DMD patients, LGE occurs early, is progressive and increases with both age and decreasing LVEF. Segmentally, the incidence of the number of positive LGE segments increase with age and lower LVEF. Older patients and those who died during the study period had more septal LGE involvement. The current studies suggest that the time course and distribution of LGE-positivity may be an important clinical biomarker to aid in the management of DMD-associated cardiac disease." (ref: https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-15-107)
Late gadolinium enhancement (LGE) is an assessment made with cardiac magnetic resonance (CMR) imaging that includes gadolinium contrast administration. The test is done to assess accumulation of gadolinium contrast material in the tissue with increased extracellular space to determine both left and right ventricle fibrosis (ref: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801263/). For LGE, the assessment relates to the timing of the reading showing whether the contrast is present or not (shown as positive or negative). If the LGE is noted as present, more assessments may be done, such as presence per segment and the percentage of presence per segment. Since contrast is important to these assessments, the Procedure Agents (AG) dataset is shown with this example.
The Procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. This example PR dataset shows the CMR imaging with 2 different MRI machines. The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset.
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.
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
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
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 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.
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
CVSEQ
CVLNKID
CVTESTCD
CVTEST
CVORRES
CVORRESU
CVSTRESC
CVSTRESN
CVSTRESU
CVLOC
CVMETHOD
CVLOBFXL
CVANMETH
VISITNUM
VISIT
CVDTC
1
DMD-LGE
CV
DMD-LGE-01-201
1
04
LGE
Late Gadolinium Enhancement
POSITIVE
POSITIVE
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
%
40
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
NEGATIVE
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
POSITIVE
POSITIVE
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
POSITIVE
POSITIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
POSITIVE
POSITIVE
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
POSITIVE
POSITIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT
MRI
VISUAL
1
VISIT 1
2023-07-01
15
DMD-LGE
CV
DMD-LGE-01-201
15
04
SGELGE
Segmental Late Gadolinium Enhancement
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
NEGATIVE
NEGATIVE
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
4
4
4
HEART, LEFT VENTRICLE
MRI
VISUAL
1
VISIT 1
2023-07-01
21
DMD-LGE
CV
DMD-LGE-01-201
21
04
LGEPER
Late Gadolinium Enhancement Percentage
40
%
40
40
%
LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT
MRI
FULL-WIDTH HALF MAXIMUM
1
VISIT 1
2023-07-01
22
DMD-LGE
CV
DMD-LGE-01-201
22
04
LGEPER
Late Gadolinium Enhancement Percentage
20
%
20
20
%
LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
MRI
FULL-WIDTH HALF MAXIMUM
1
VISIT 1
2023-07-01
23
DMD-LGE
CV
DMD-LGE-01-201
23
04
LGEPER
Late Gadolinium Enhancement Percentage
45
%
45
45
%
LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT
MRI
FULL-WIDTH HALF MAXIMUM
1
VISIT 1
2023-07-01
24
DMD-LGE
CV
DMD-LGE-01-201
24
04
LGEPER
Late Gadolinium Enhancement Percentage
20
%
20
20
%
LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT
MRI
FULL-WIDTH HALF MAXIMUM
1
VISIT 1
2023-07-01
25
DMD-LGE
CV
DMD-LGE-01-202
1
05
LGE
Late Gadolinium Enhancement
NEGATIVE
NEGATIVE
HEART, LEFT VENTRICLE
MRI
VISUAL
1
VISIT 1
2023-07-05
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Procedure Agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. This example AG dataset 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-LGE
AG
DMD-LGE-01-201
1
04
Gd-DOTA
CONTRAST AGENT
8
mL
SOLUTION
INTRAVENOUS
VISIT 1
2023-07-01T09:25:00
2
DMD-LGE
AG
DMD-LGE-01-202
2
05
Gd-DOTA
CONTRAST AGENT
10
mL
SOLUTION
INTRAVENOUS
VISIT 1
2023-07-05
$warningHtml
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.
di.xpt
di.xpt
Row
STUDYID
DOMAIN
SPDEVID
DISEQ
DIPARMCD
DIPARM
DIVAL
1
DMD-LGE
DI
ABC001
1
DEVTYPE
Device Type
CMR Scanner
2
DMD-LGE
DI
ABC002
1
DEVTYPE
Device Type
CMR Scanner
$warningHtml
The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
$titleHtml
relrec.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
RELTYPE
RELID
1
DMD-LGE
PR
PRLNKID
ONE
04
2
DMD-LGE
CV
CVLNKID
MANY
04
3
DMD-LGE
AG
AGLNKID
ONE
04
$warningHtml
For more information on the domains used in this section see:
Procedures (PR) - SDTMIG v3.4, Section 6.1.5
Cardiovascular System Findings (CV) - SDTMIG v3.4, Section 6.3.7.2