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Late gadolinium enhancement (LGE) is shown to increase over time for patients with DMD. Cardiac magnetic resonance (CMR) imaging is used to assess ventricular function and myocardial fibrosis by LGE. "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)

LGE assessments may be done on each of the cardiovascular segments as shown in Figure 1. (ref: https://www.ahajournals.org/doi/full/10.1161/hc0402.102975)

Figure 1. Left Ventricular Segments

1 = basal anterior; 2 = asal anteroseptal; 3 = basal inferoseptal; 4 = basal inferior; 5 = basal inferolateral; 6 = basal anterolateral; 7 = mid anterior; 8 = mid anteroseptal; 9 = mid inferoseptal; 10 = mid inferior; 11 = mid inferolateral; 12 = mid anterolateral; 13 = apical anterior; 14 = apical septal; 15 = apical inferior; 16 = apical lateral; 17 = apex.

The SDTM examples in this section show 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.

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

MRIHEART

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

1DMD-LGECVDMD-LGE-01-201104LGELate Gadolinium Enhancement

POSITIVE


POSITIVE



HEART, LEFT VENTRICLEMRI
VISUAL1VISIT 12023-07-01
2DMD-LGECVDMD-LGE-01-201204LGEPERLate Gadolinium Enhancement Percentage

40

%

40

40%HEART, LEFT VENTRICLEMRI
QUANTITATIVE1VISIT 12023-07-01
3DMD-LGECVDMD-LGE-01-201304SGELGE

Segmental Late Gadolinium Enhancement

NEGATIVE

NEGATIVE



LEFT VENTRICULAR BASAL ANTERIOR SEGMENTMRI
VISUAL1VISIT 12023-07-01
4DMD-LGECVDMD-LGE-01-201404SGELGESegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
5DMD-LGECVDMD-LGE-01-201504SGELGESegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
VISUAL1VISIT 12023-07-01
6DMD-LGECVDMD-LGE-01-201604SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFERIOR SEGMENT

MRI
VISUAL1VISIT 12023-07-01
7DMD-LGECVDMD-LGE-01-201704SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT

MRI
VISUAL1VISIT 12023-07-01
8DMD-LGECVDMD-LGE-01-201804SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
9DMD-LGECVDMD-LGE-01-201904SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTERIOR SEGMENTMRI
VISUAL1VISIT 12023-07-01
10DMD-LGECVDMD-LGE-01-2011004SGELGESegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
11DMD-LGECVDMD-LGE-01-2011104SGELGESegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
12DMD-LGECVDMD-LGE-01-2011204SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFERIOR SEGMENTMRI
VISUAL1VISIT 12023-07-01
13DMD-LGECVDMD-LGE-01-2011304SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFEROLATERAL SEGMENT

MRI
VISUAL1VISIT 12023-07-01
14DMD-LGECVDMD-LGE-01-2011404SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT

MRI
VISUAL1VISIT 12023-07-01
15DMD-LGECVDMD-LGE-01-2011504SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL ANTERIOR SEGMENTMRI
VISUAL1VISIT 12023-07-01
16DMD-LGECVDMD-LGE-01-2011604SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL SEPTAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
17DMD-LGECVDMD-LGE-01-2011704SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL INFERIOR SEGMENTMRI
VISUAL1VISIT 12023-07-01
18DMD-LGECVDMD-LGE-01-2011804SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL LATERAL SEGMENTMRI
VISUAL1VISIT 12023-07-01
19DMD-LGECVDMD-LGE-01-2011904SGELGESegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APEX SEGMENTMRI
VISUAL1VISIT 12023-07-01
20DMD-LGECVDMD-LGE-01-2012004

LGESEGCT

Late Gadolinium Enhancement Segment Ct

4


4

4
HEART, LEFT VENTRICLEMRI
VISUAL1VISIT 12023-07-01
21DMD-LGECVDMD-LGE-01-2012104LGEPERLate Gadolinium Enhancement Percentage

40

%

40

40%LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENTMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
22DMD-LGECVDMD-LGE-01-2012204LGEPERLate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENTMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
23DMD-LGECVDMD-LGE-01-2012304LGEPERLate Gadolinium Enhancement Percentage

45

%

45

45%LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
24DMD-LGECVDMD-LGE-01-2012404LGEPERLate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
25DMD-LGECVDMD-LGE-01-202105LGELate Gadolinium Enhancement

NEGATIVE


NEGATIVE



HEART, LEFT VENTRICLEMRI
VISUAL1VISIT 12023-07-05
$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
  • Procedure Agents (AG) - SDTMIG v3.4 Section 6.1.1
  • Device Identifiers (DI) - SDTMIG-Medical Devices v1.1, Section 3.1

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