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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 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 The Procedures (PR) domain contains interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects. The This example PR dataset below shows the cardiac magnetic resonance CMR imaging with two 2 different MRI machines. The sponsor device identifier (SPDEVID) variable  variable is used to represent the imaging device identifier information provided in the DI dataset below.

Dataset wrap
Namepr
Rowcaps

Row 1:

Shows the results procedure of a cardiac MRI for participant DMD-LGE-01-201.

Row 2:

Shows the results 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.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

PRSEQ

SPDEVID

PRREFID

PRLNKID

PRTRT

PRLOC

PRFAST

PRSTDTC

1

DMD-EFLGELGE

PR

DMD-LGE-01-201

1

ABC001

12345678

04

MRI

HEARTCARDIAC MAGNETIC RESONANCE IMAGING

Y

2023-07-01T09:15:00

2

DMD-EFLGELGE

PR

DMD-LGE-01-202

1

ABC002

98765432

05

MRIHEARTCARDIAC MAGNETIC RESONANCE IMAGING

N

2023-07-05

The This example CV dataset below shows   the 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 [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 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.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVLOC

CVMETHOD

CVLOBFXL

CVANMETH

VISITNUM

VISIT

CVDTC

1DMD-EFLGELGECVDMD-LGE-01-201104LGELATE GADOLINIUM ENHANCEMENTLate Gadolinium Enhancement

POSITIVE


POSITIVE



HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
2DMD-EFLGELGECVDMD-LGE-01-201204LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

40

%

40

40%HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
QUANTITATIVE1VISIT 12023-07-01
3DMD-EFLGELGECVDMD-LGE-01-201304SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

Segmental Late Gadolinium Enhancement

NEGATIVE

NEGATIVE



LEFT VENTRICULAR BASAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
4DMD-EFLGELGECVDMD-LGE-01-201404SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
5DMD-EFLGELGECVDMD-LGE-01-201504SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
6DMD-EFLGELGECVDMD-LGE-01-201604SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFERIOR SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
7DMD-EFLGELGECVDMD-LGE-01-201704SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
8DMD-EFLGELGECVDMD-LGE-01-201804SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
9DMD-EFLGELGECVDMD-LGE-01-201904SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
10DMD-EFLGELGECVDMD-LGE-01-2011004SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
11DMD-EFLGELGECVDMD-LGE-01-2011104SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

POSITIVE


POSITIVE



LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
12DMD-EFLGELGECVDMD-LGE-01-2011204SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
13DMD-EFLGELGECVDMD-LGE-01-2011304SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
14DMD-EFLGELGECVDMD-LGE-01-2011404SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTEROLATERAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
15DMD-EFLGELGECVDMD-LGE-01-2011504SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
16DMD-EFLGELGECVDMD-LGE-01-2011604SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL SEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
17DMD-EFLGELGECVDMD-LGE-01-2011704SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
18DMD-EFLGELGECVDMD-LGE-01-2011804SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL LATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
19DMD-EFLGELGECVDMD-LGE-01-2011904SGELGESEGMENTAL LATE GADOLINIUM ENHANCEMENTSegmental Late Gadolinium Enhancement

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APEX SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
20DMD-EFLGELGECVDMD-LGE-01-2012004

LGESEGCT

LATE GADOLINIUM ENHANCEMENT SEGMENT CT

Late Gadolinium Enhancement Segment Ct

4


4

4
HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-01
21DMD-EFLGELGECVDMD-LGE-01-2012104LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

40

%

40

40%LEFT VENTRICULAR BASAL ANTEROSEPTAL ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
22DMD-EFLGELGECVDMD-LGE-01-2012204LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR BASAL INFEROSEPTAL ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
23DMD-EFLGELGECVDMD-LGE-01-2012304LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

45

%

45

45%LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
24DMD-EFLGELGECVDMD-LGE-01-2012404LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGELate Gadolinium Enhancement Percentage

20

%

20

20%LEFT VENTRICULAR MID INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGMRI
FULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
25DMD-EFLGELGECVDMD-LGE-01-202105LGELATE GADOLINIUM ENHANCEMENTLate Gadolinium Enhancement

NEGATIVE


NEGATIVE



HEART, LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGMRI
VISUAL1VISIT 12023-07-05

The procedure agents Procedure Agents (AG) domain contains the agents administered to the subject as part of a procedure or assessment. The This example AG dataset below shows the timing of the gadolinium-based contrast, ' Gd-DOTA'. The time the contrast was given to participant DMD-EFLGELGE-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-LGE-01-201

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-01T09:25:00

2

DMD-EFLGELGE

AG

DMD-LGE-01-202

2

0405

Gd-DOTA

CONTRAST AGENT

10

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-05

The device identifiers 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 sequence number (DISEQ) is specific to each device; note there are two 2 different CMR scanners noted with different values in the SPDEVID variable. Each scanners scanner has a value of "1" for the DISEQ variable since there is only one 1 record or row for each device.

Dataset wrap
Namedi
Dataset2

Row

STUDYID

DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

DMD-EFLGELGE

DI

ABC001

1

DEVTYPE

Device Type

CMR Scanner

2

DMD-EFLGELGE

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