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Comment: In the PR domain, changed "results" to "procedure" since the PR domain is showing the procedure and not the results... typo?

This example dataset shows the findings of a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. Different levels of granularity are shown with the various tests and details that might be represented. The research requirements will determine what level of granularity is needed. For example, a study using LGE may require LGE test in their data without the detail of the analysis method. Alternatively, researchers may be interested in understanding if the assessments were done visually or with quantitative methods. If the study includes an assessment of each segment such as with the Segmental Late Gadolinium Enhancement Percentage, there may be interest in representing the quantitative analysis method of "Full-width half maximum" which is one of the types of analysis that may be done. The example provides how to represent this type of information if the researchers are interested in this type of information for the study data. https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-16-45

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

Excerpt IncludeFigure 1. Left Ventricular SegmentsFigure 1. Left Ventricular SegmentsThis example includes example datasets to reflect how the CMR procedure and the contrast would be represented in the data.The Procedures (PR) domain represents 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 MRI machines, using the SPDEVID . The sponsor device identifier (SPDEVID) variable is used to represent the imaging device identifier information provided in the DI dataset below. The ANMETH variable describes the analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence) which in this case applies to the CMR imaging. There are machine-centric analysis methods inherit to the type of machine (e.g.,full-width half maximum, 5 standard deviations, 6 standard deviations). https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-12-21 These may be of interest for the study and would be represented using the ANMETH variable.

Dataset wrap
Namepr
Rowcaps

Row 1:

Shows the procedure of a cardiac MRI for participant DMD-EFLGELGE-01-101201.

Row 2:

Shows the procedure of a cardiac MRI for participant DMD-EFLGELGE-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.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

PRSEQ

SPDEVIDPRSEQ

PRREFID

PRLNKID

PRTRT

PRLOC

PRFAST

PRSTDTC

1

DMD-EFLGELGE

PR

DMD-EFLGELGE-01-101201

1

ABC001

1

12345678

04

MRI

HEARTCARDIAC MAGNETIC RESONANCE IMAGING

Y

2023-07-01T09:15:00

2

DMD-EFLGELGE

PR

DMD-EFLGELGE-01-202

1

ABC0021

98765432

05

MRIHEARTCARDIAC MAGNETIC RESONANCE IMAGING

N

2023-07-05

The Cardiovascular System Findings (CV) domain represents 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. If LGE was not performed, it would not appear in the datasetThis 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.

Dataset wrap
Namecv
Rowcaps

Row 1:

Shows the late gadolinium enhancement that LGE is positive for subject participant DMD-EFLGELGE-01-101201.

Row 2:

Shows the total late gadolinium enhancement LGE percentage is 40% for subject DMD-EFLGE-01-101.

Rows 3-19:

Show the segmental late gadolinium enhancement LGE results for each of the left ventricle segments for subject DMD-EFLGE-01-101.

Row 20:

Shows the late gadolinium enhancement LGE segment count for subject DMD-EFLGE-01-101.

Rows 21-24:

Show the segmental late gadolinium enhancement LGE percentage for each of the positive segments for subject DMD-EFLGE-01-101

Row 25:

Shows the late gadolinium enhancement that LGE is negative for subject participant DMD-EFLGELGE-01-202.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVLOC

CVMETHOD

CVLOBFXL

CVANMETH

VISITNUM

VISIT

CVDTC

1DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201104LGE
LATE GADOLINIUM ENHANCEMENT
Late Gadolinium Enhancement

POSITIVE


POSITIVE



HEART, LEFT VENTRICLE
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
2DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201204
TLGEPER
LGEPERLate Gadolinium Enhancement Percentage
TOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE

40

%

40

40%HEART, LEFT VENTRICLE
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
QUANTITATIVE1VISIT 12023-07-01
3DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201304
SGTLGE
SGELGE

Segmental Late Gadolinium Enhancement

SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE

NEGATIVE



LEFT VENTRICULAR BASAL ANTERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
4DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201404
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
5DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201504
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
6DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201604
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFERIOR SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
7DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201704
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
8DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201804
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
9DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
201904
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
10DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011004
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
11DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011104
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
12DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011204
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
13DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011304
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
14DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011404
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
15DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011504
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL ANTERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
16DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011604
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL SEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
17DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011704
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
18DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011804
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL LATERAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
19DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2011904
SGTLGE
SGELGESegmental Late Gadolinium Enhancement
SEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APEX SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
20DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2012004
LGESEGC

LGESEGCT

Late Gadolinium Enhancement Segment Ct

LATE GADOLINIUM ENHANCEMENT SEGMENT COUNT

4


4

4
HEART, LEFT VENTRICLE
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-07-01
21DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2012104LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

40

%

40

40%LEFT VENTRICULAR BASAL
ANTEROSEPTAL
ANTEROLATERAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
22DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2012204LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR BASAL
INFEROSEPTAL
ANTEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
23DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2012304LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

45

%

45

45%LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
24DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-
101
2012404LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR MID INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
25DMD-
EFLGE
LGECVDMD-
EFLGE
LGE-01-202105LGE
LATE GADOLINIUM ENHANCEMENT
Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



HEART, LEFT VENTRICLE
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
VISUAL1VISIT 12023-
08
07-05

The Procedure Agent Agents (AG) represents domain contains the agents administered to the participant subject as part of a procedure or assessment. The This example AG dataset shows the timing of the 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.

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

VISITNUM

AGSTDTC

1

DMD-EFLGELGE

AG

DMD-EFLGELGE-01-101201

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-01T09:25:00

2

DMD-EFLGELGE

AG

DMD-EFLGELGE-01-202

2

0405

Gd-DOTA

CONTRAST AGENT

10

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-05

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.

Dataset wrap
Namedi
Dataset2

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

The RELREC dataset is used to describe the relationship between 2 or more records in different domains.

Dataset wrap
Namerelrec
Dataset2

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