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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 DMD-RT-01-301. 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.

Dataset wrap
Namepr
Dataset2
Row

STUDYID

DOMAIN

USUBJID

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRSTDTC

1

DMD-RT

PR

DMD-RT-01-301

ABC001

1

12345678

04

CARDIAC MAGNETIC RESONANCE IMAGING

2023-08-01

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".

Dataset wrap
Namecv
Rowcaps

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 = "CARDIOVASCULAR SYSTEM FINDINGS" and CVMETHOD = "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".
Dataset2

Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVSTAT

CVREASND

CVLOC

CVMETHOD

CVLOBFXL

VISITNUM

VISIT

CVTPT

CVTPTREF

CVDTC


CVOIQ

1DMD-RTCVDMD-RT-01-3011T1LONGITUDINAL 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-RTCVDMD-RT-01-3012T1LONGITUDINAL RELAXATION TIME (T1 TIME)1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
3DMD-RTCVDMD-RT-01-3013T1LONGITUDINAL RELAXATION TIME (T1 TIME)

980

ms

980

980ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
4DMD-RTCVDMD-RT-01-3014T2TRANSVERSE RELAXATION TIME (T2 TIME)

45

ms4545ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
5DMD-RTCVDMD-RT-01-3015T2TRANSVERSE RELAXATION TIME (T2 TIME)

40

ms4040ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
6DMD-RTCVDMD-RT-01-3016T2TRANSVERSE RELAXATION TIME (T2 TIME)

48

ms4848ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
7DMD-RTCVDMD-RT-01-3017T1LONGITUDINAL RELAXATION TIME (T1 TIME)

450

ms450450ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
8DMD-RTCVDMD-RT-01-3018MYECV

MYOCARDIAL EXTRACELLULAR VOLUME

25

%2525%



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
9DMD-RTCVDMD-RT-01-3021CVALLCARDIOVASCULAR SYSTEM FINDINGS




NOT DONE

NON-EVALUABLE IMAGE

HEART

CARDIAC MAGNETIC RESONANCE IMAGING
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05
NON-EVALUABLE IMAGE
10DMD-RTCVDMD-RT-01-3031CVALLCARDIOVASCULAR SYSTEM FINDINGS




NOT DONE

UNABLE TO PLACE INTRAVENOUS LINE

HEART

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

Nsvmeta
DomainCV

Variable

Label

Type

Role

Origin

CVOIQOverall Image QualitytextNon-standard Record QualifierCRF

...

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-LGERT

AG

DMD-RT-01-301

1

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-08-01

...

Dataset wrap
Namedi
Dataset2

Row

STUDYID

DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

DMD-LGERT

DI

ABC001

1

DEVTYPE

Device Type

CMR Scanner

2

DMD-LGERT

DI

ABC001

2

MANUF

Manufacturer

ACME

3

DMD-LGERT

DI

ABC001

3

TRADENAM

Trade Name

ACME 64

4

DMD-LGERT

DI

ABC001

4

MODEL

Model Number

CMR540

...

Dataset wrap
Namedo
Dataset2
Row

STUDYID

DOMAIN

SPDEVID

DOSEQ

DOTESTCD

DOTEST

DOORRES

DOORRESU

1

DMD-LGERT

DO

ABC002

1

SFTWRNAM

Software Name

CMRRLXU2


2

DMD-LGERT

DO

ABC002

2

SFTWRVER

Software Version

CMRLX.2


3

DMD-LGERT

DO

ABC002

3IMAQDIMImage Acquisition Dimensionality3

...

Dataset wrap
Namedu
Dataset2
Row

STUDYID

DOMAIN

USUBJID

SPDEVID

DUSEQ

DUREFID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

DUDTC

1

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

1

12345678

ANTPLANAnatomical PlaneSAGITTAL
SAGITTAL

2023-08-01

2

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

2

12345678

PULSSEQPulse SequenceSPGR
SPGR

2023-08-01

3

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

3

12345678

FLIPANGLFlip Angle50deg5050deg

2023-08-01

4

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

4

12345678

INTDISTM

Interslice Distance

1mm11mm

2023-08-01

5

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

5

12345678

STHICKSlice Thickness6mm66mm

2023-08-01

6

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

6

12345678

FLDVIEWField of View32X38cm32X3832X38cm

2023-08-01

7

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

7

12345678

NUMSLICENumber of Slices12
1212

2023-08-01

8

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

8

12345678

COILSTRCoil Strength1.5T1.51.5T

2023-08-01

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.

Dataset wrap
Namerelrec
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

DMD-LGERT

PR


PRLNKID


ONE

04

2

DMD-LGERT

CV


CVLNKID


MANY

04

3

DMD-LGERT

AG


AGLNKID


ONE

04