Versions Compared

Old Version 13

changes.mady.by.user Rebecca Baker

Saved on

compared with

New Version Current

changes.mady.by.user Rebecca Baker

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: In the PR domain, changed "results" to "procedure" since the PR domain is showing the procedure and not the results... typo?

For LGE - Late Gadiolium Enhancement, it is dealing with the timing of the reading. Often it is either present or not present. If present, they may look at presence per segment (even provide the percentage of the presence per segment).

The image is read 8-10 minutes after the contrast is given.

Determined this would be an indicator test and there is an additional term LGE percentage.

...

  1. It is the only term in CT that fits.  It seems wrong because technically if there is a mass within the heart, it would be seen on the CMR imaging.

...

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.

Dataset wrap
Namepr
Rowcaps

Row 1:

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

Row 2:

Shows the procedure of a cardiac MRI for subject 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.

CARDIAC WALL
Dataset2
Row

STUDYID

DOMAIN

USUBJID

PRSEQ

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRLOC

PRFAST

PRSTDTC

1

DMD-LGE

PR

DMD-LGE-01-201

1

ABC001

1

12345678

04

CARDIAC MAGNETIC RESONANCE IMAGING

MRI

HEART

Y

2023-07-

01T08

01T09:

55

15:00

2

DMD-LGE

PR

DMD-LGE-01-202

1

ABC002

2

98765432

05

CARDIAC MAGNETIC RESONANCE IMAGING
MRIHEART
CARDIAC WALL

N

2020

2023-07-

02T10:05:00

05

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.

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 3-19Rows 1-5:

Show the late gadolinium enhancement (LGE) is present and affecting 4 segments with corresponding percentage for each segment for subject 201.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-

Row 6:

Shows the late gadolinium enhancement (LGE) is absent for subject 202.

SCREENING
Dataset2
Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVLOC

CVMETHOD

CVLOBFXL

CVANMETH

VISITNUM

VISIT

CVDTC

1DMD-LGECVDMD-LGE-01-201104
LATE GADOLINIUM ENHANCEMENT

PRESENT

PRESENT

CARDIAC MAGNETIC RESONANCE IMAGING1
LGELate 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-01-2011804
LATE GADOLINIUM ENHANCEMENT (# of segments)
SGELGESegmental 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
VISUAL
CARDIAC MAGNETIC RESONANCE IMAGING
1
SCREENING
VISIT 12023-07-01
3
21DMD-LGECVDMD-LGE-01-201
3
2104LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

40

20

%
20

40

20
40%LEFT VENTRICULAR BASAL
ANTERIOR
ANTEROLATERAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1
SCREENING
VISIT 12023-07-01
4
22DMD-LGECVDMD-LGE-01-201
4
2204LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

20

30

%
30

20

30
20%LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1
SCREENING
VISIT 12023-07-01
5
23DMD-LGECVDMD-LGE-01-201
5
2304LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

45

%

45

45%LEFT VENTRICULAR MID
INFERIOR
ANTEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1
SCREENING
VISIT 12023-07-01
5
24DMD-LGECVDMD-LGE-01-201
6
2404LGEPER
LATE GADOLINIUM ENHANCEMENT PERCENTAGE
Late Gadolinium Enhancement Percentage

20

50

%
50

20

50
20%
RIGHT
LEFT VENTRICULAR MID
INFERIOR
INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
FULL-WIDTH HALF MAXIMUM1
SCREENING
VISIT 12023-07-01
1
25DMD-LGECVDMD-LGE-01-202105
LATE GADOLINIUM ENHANCEMENT

ABSENT

ABSENT

CARDIAC MAGNETIC RESONANCE IMAGING1
LGELate Gadolinium Enhancement

NEGATIVE


NEGATIVE



HEART, LEFT VENTRICLEMRI
VISUAL1VISIT 1
SCREENING
2023-07-
01
05

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

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

VISITNUM

AGSTDTC

1

DMD-LGE

AG

DMD-LGE-01-201

1

04GADOLINIUM

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-01T0801T09:4525:00

12

DMD-LGE

AG

DMD-LGE-01-202

12

05GADOLINIUM

Gd-DOTA

CONTRAST AGENT

10

mL

SOLUTION

INTRAVENOUS

VISIT 1

2023-07-05T09:55:00-05

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