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The example includes information about how to represent imaging device information in the event that the research requires this type of data.

The PR dataset shows the procedure of cardiac magnetic resonance imaging using the device associated with SPDEVID ABC001 and the PRREFID of 12345678. This information shows what CMR device is used for the procedure and the accession number or procedure reference identifier associated with the specific procedure for subject 301. The SPDEVID variable is used to relate records by the device (in this case, the CMR machine). The Device Identifier (DI) domain represents the device information details, the Device Properties (DO) domain represents characteristics of the device that do not vary between subjects. The Device-In-Use (DU) domain represents settings that are set on a device when it is used and may vary between participants.

pr.xpt

pr.xpt

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRSTDTC

1

DMD-RT

PR

301

ABC001

1

12345678

04

CARDIAC MAGNETIC RESONANCE IMAGING

2023-08-01

$warningHtml
The Cardiovascular System Findings (CV) domain represents physiological and morphological findings related to the cardiovascular system so it holds the assessments from the parametric mapping. The example CV dataset below shows how to represent longitudinal relaxation time, transverse relaxation time and extracellular volume findings from CMR. The timing of the contrast specificity is noted using the CVTPT to note if the CVTEST was done before or after contrast. CVTPTREF associates the timepoints in CVTPT with "contrast administration." In the example below, row 9 shows an unreadable CMR using the CVSTAT variable populated with "NOT DONE" and the CVREASND variable shows the reason the procedure was not done, or in this case the result not provided which was a non-evaluable image. A similar approach may be used if there is a desire to record that the CMR was not obtained at the specific visit (omitting the poor-quality information) and why in the dataset records. The non-standard variable CVOIQ=Cardiovascular Overall Image Quality is used to represent if the image for the evaluation is non-evaluable", "evaluable", "evaluable Image - sub-optimal", or "evaluable image - optimal".
Rows 1-6:Show the T1 Longitudinal Relaxation Time, and the T2 Transverse Relaxation Time, (Native T1 Mapping) for different segments of the heart prior to contrast for CMR.
Rows 7-8:Show the T1 Longitudinal Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart after contrast for CMR.
Row 9:Shows participant 302 had a CMR procedure that was unreadable, CVREASND = "NON-EVALUABLE". This is denoted by CVTESTCD of CVALL for "CARDIOVASCULAR SYSTEM FINDINGS with the METHOD of "CARDIAC MAGNETIC RESONANCE IMAGING".
Row 10:Shows participant 303 did not have a CMR procedure because they were unable to place an intravenous access line, CVREASND = "UNABLE TO PLACE INTRAVENOUS LINE".

cv.xpt

cv.xpt

Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVSTAT

CVREASND

CVLOC

CVMETHOD

CVLOBFXL

VISITNUM

VISIT

CVTPT

CVTPTREF

CVDTC


CVOIQ

1DMD-RTCV3011T1LONGITUDINAL RELAXATION TIME (T1 TIME)

1315

ms

1315

1315ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
2DMD-RTCV3012T1LONGITUDINAL RELAXATION TIME (T1 TIME)1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
3DMD-RTCV3013T1LONGITUDINAL RELAXATION TIME (T1 TIME)

980

ms

980

980ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
4DMD-RTCV3014T2TRANSVERSE RELAXATION TIME (T2 TIME)

45

ms4545ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
5DMD-RTCV3015T2TRANSVERSE RELAXATION TIME (T2 TIME)

40

ms4040ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
6DMD-RTCV3016T2TRANSVERSE RELAXATION TIME (T2 TIME)

48

ms4848ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
7DMD-RTCV3017T1LONGITUDINAL RELAXATION TIME (T1 TIME)

450

ms450450ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
8DMD-RTCV3018EXTRAVOLEXTRACELLULAR VOLUME

25

%2525%



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
9DMD-RTCV3021CVALLCARDIOVASCULAR SYSTEM FINDINGS




NOT DONE

NON-EVALUABLE IMAGE

HEART

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05
NON-EVALUABLE IMAGE
10DMD-RTCV3031CVALLCARDIOVASCULAR SYSTEM FINDINGS




NOT DONE

UNABLE TO PLACE INTRAVENOUS LINE

HEART

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05

$warningHtml

CV NSV Metadata

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The AG dataset shows the Gadolinium based contrast that was used for the procedure. In this example, the researchers did not collect the time of the contrast.

ag.xpt

ag.xpt

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-LGE

AG

301

1

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-08-01

$warningHtml
DI holds the device identifier information that describes the device used to produce the image that was the basis of the interpretation recorded in the CV domain. Characteristics in DI are those necessary to identify each device to the level of granularity necessary for the study (e.g., to the model level if knowing the actual unit is not necessary, to the serial number level if there is a need to distinguish among units).

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

ABC001

2

MANUF

Manufacturer

ACME

3

DMD-LGE

DI

ABC001

3

TRADENAM

Trade Name

ACME 64

4

DMD-LGE

DI

ABC001

4

MODEL

Model Number

CMR540

$warningHtml
Fixed properties of devices identified in DI are represented in the DO domain. The sponsor chose to keep the software version constant throughout the study. DO should contain properties that are important for interpreting the data. 

do.xpt

do.xpt

Row

STUDYID

DOMAIN

SPDEVID

DOSEQ

DOTESTCD

DOTEST

DOORRES

DOORRESU

1

DMD-LGE

DO

ABC002

1

SFTWRNAM

Software Name

CMRRLXU2


2

DMD-LGE

DO

ABC002

2

SFTWRVER

Software Version

CMRLX.2


3

DMD-LGE

DO

ABC002

3IMAQDIMImage Acquisition Dimensionality3
$warningHtml
Changeable properties and parameters of the devices identified in DI are represented in the DU domain. These settings could be linked to the record in the CV domain by their shared SPDEVID and DTC values. For the sake of brevity, only 1 subject's parameters are shown. For more information on relating records, see SDTMIG v3.4 Section 8.2, Relating Peer Records. 

du.xpt

du.xpt

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

DUSEQ

DUREFID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

DUDTC

1

DMD-LGE

DU

301

ABC001

1

12345678

ANTPLANAnatomical PlaneSAGITTAL
SAGITTAL

2023-08-01

2

DMD-LGE

DU

301

ABC001

2

12345678

PULSSEQPulse SequenceSPGR
SPGR

2023-08-01

3

DMD-LGE

DU

301

ABC001

3

12345678

FLIPANGLFlip Angle50deg5050deg

2023-08-01

4

DMD-LGE

DU

301

ABC001

4

12345678

INTDISTM

Interslice Distance

1mm11mm

2023-08-01

5

DMD-LGE

DU

301

ABC001

5

12345678

STHICKSlice Thickness6mm66mm

2023-08-01

6

DMD-LGE

DU

301

ABC001

6

12345678

FLDVIEWField of View32X38cm32X3832X38cm

2023-08-01

7

DMD-LGE

DU

301

ABC001

7

12345678

NUMSLICENumber of Slices12
1212

2023-08-01

8

DMD-LGE

DU

301

ABC001

8

12345678

COILSTRCoil Strength1.5T1.51.5T

2023-08-01

$warningHtml
The RELREC dataset is used to describe the relationship between 2 or more records in different domains. For more information on relating records see SDTMIG v3.4, Section 8.2.
$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

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