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This example Procedures (PR) dataset includes the SPDEVID variable to show what device was used and the PRREFID variable to represent the accession number or procedure reference identifier associated with the specific procedure. SPDEVID was used to link this PR record to the device records.

Dataset wrap
Namepr
Dataset2
Row

STUDYID

DOMAIN

USUBJID

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRLOC

PRSTDTC

1

DMD-RT

PR

DMD-RT-01-301

ABC001

1

12345678

04

MRI

HEART

2023-08-01

This example cardiovascular system findings (CV) dataset shows how to represent longitudinal relaxation time, transverse relaxation time, and extracellular volume findings from CMR imaging. This example includes records for an unreadable image and an unperformed test. For these records, CVSTAT was populated with "NOT DONE" and CVREASND was populated with the reason the result was not provided or the procedure was not done. An NSV was used to represent image quality

Call lit Parametric mapping: then use T1, T2, ECV in the example.

"T1 mapping stands for registering the course of recovery of longitudinal magnetism", this means the relaxation time after either the preparation step (saturation or inversion prepulse) followed by the acquisition of images at several time points during the T1 recover/relaxation. T1 value represents the time when recovery of magnetism has reached a percentage of its original state (63%). The recovery rate relates to the myocardial tissue properties that may be altered by pathological tissue presence (https://www.ahajournals.org/doi/10.1161/circresaha.116.307974). T1 mapping values increase with disease, and decrease post contrast.

Info
  1. What is the difference between T1 and T2? Should there be any differences in the data collected for each of these?
  2. Do we need minimum and maximum values? for SI mean, area, circumference, SI mean, SI min/max?- will change depending on the (also changes after contrast)- NA; in the context of research do they collect this - no. Not relevant.
  3. Do we need timepoints for the T1 measurement or just the point in time of the final assessment?
  4. Does Cardiac Motion correction need to be indicated? If yes, does the type need to be indicated (such as the modified LL (MOLLI) sequence)?  If yes, should this be reflected on each result? (Alana/Jon/Diane - I am considering a "Cardiac Motion Correction Indicator" NSV)
  5. Do we need a postcontrast indicator since those measurement differ? or is that what the terms "native T1" (no contrast) and "post-contrast T1" (after contrast) mean?
  6. Three is a "gold" standard noted as the "T1 mapping based on the acquisition of single images by a T1 turbo spin-echo sequence". It is noted as the ultimate T1 mapping method. Does the method need to be called out by what kind of acquisition sequence was used?
  7. For the location does the intracellular compartment need to be noted? (myocytes, fibroblasts, endothelial cells, smooth muscle cells)
  8. Does the cardiac phase for the specific T1 segment need to be noted? (atrial systole-diastole; isovolumentric contraction-diastole; rapid ejection-systole; reduced ejection-systole; isovolumetric relaxation-diastole; rapid ventricular filling-diastole)
  9. Is it important to record the "MRI scanner type" (Avanto, Siemens; Best, Philips; Acheiva, Philips), the "reception coil" (16-channel; 32-channel), "the T1 mapping sequence" (MOLLI; ShMOLLI)

The following example shows the T1 mapping results for USUBJID 301. For brevity, after contrast only one of each test was shown in this example.

Dataset wrap
Namecv
Rowcaps

Rows 1-106:

Show the

T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume

longitudinal relaxation time and the transverse relaxation time for different segments of the heart prior to contrast

for CMR

(CVTPT = BEFORE and CVTPTREF = CONTRAST ADMINISTRATION).

Rows 117-148:

Show the

T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart after contrast for CMR

longitudinal relaxation time and myocardial extracellular volume for the LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT after contrast (CVTPT = AFTER and CVTPTREF = CONTRAST ADMINISTRATION).

Row 9:

Shows an unreadable CMR result for participant DMD-RT-01-302, CVREASND = "NON-EVALUABLE IMAGE".

Row 10:

Shows participant DMD-RT-01-303 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

CVLNKID

CVTESTCD

CVTEST

CVCAT

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVSTAT

CVREASND

CVLOC

CVMETHOD

CVLOBFXL

VISITNUM

VISIT

CVTPT

CVTPTREF

CVDTC


CVOIQ

1DMD-RTCVDMD-RT-01-301104T1
LONGITUDINAL RELAXATION TIME

Pre-contrast

Longitudinal Relaxation Time

1315

ms

1315

1315ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING

MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
2DMD-RTCVDMD-RT-01-301204T1
LONGITUDINAL RELAXATION TIMEPre-contrast
Longitudinal Relaxation Time1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
3DMD-RTCVDMD-RT-01-301304T1
LONGITUDINAL RELAXATION TIME

Pre-contrast

Longitudinal Relaxation Time

980

ms

980

980ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
4DMD-RTCVDMD-RT-01-301404T2
TRANSVERSE RELAXATION TIME

Pre-contrast

under 49 change to 40 to 50; 50,60 is high

Transverse Relaxation Time

45

ms4545
ms
ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
5DMD-RTCVDMD-RT-01-301504T2
TRANSVERSE RELAXATION TIME

Pre-contrast

Transverse Relaxation Time

40

ms4040
ms
ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
6DMD-RTCVDMD-RT-01-301604T2
TRANSVERSE RELAXATION TIME
Transverse Relaxation Time

48

Pre-contrast

ms4848ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
7DMD-RTCVDMD-RT-01-301704
NATIVE
T1
MAPPINGPre-contrast
Longitudinal Relaxation Time

450

1070

ms
1070
450
1070
450ms
CARDIAC MAGNETIC RESONANCE IMAGING1



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1AFTERCONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
8DMD-RTCVDMD-RT-01-3018
EXTRAVOL
04
EXTRACELLULAR VOLUME

Pre-contrast

1.5

/s

1.5

1.5
MYECV

Myocardial Extracellular Volume

25

%2525%
/s



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
9DMD-RTCVDMD-RT-01-3021
CVALLCardiovascular System Findings




NOT DONE

NON-EVALUABLE IMAGE

HEART

MRI
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05
NON-EVALUABLE IMAGE
10DMD-RTCVDMD-RT-01-3031
CVALLCardiovascular System Findings




NOT DONE

UNABLE TO PLACE INTRAVENOUS LINE

HEART

MRI
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05

Nsvmeta
DomainCV

Variable

Label

Type

Role

Origin

CVOIQOverall Image QualitytextNon-standard Record QualifierCRF

The example Procedure Agents (AG) dataset shows details for the gadolinium-based contrast used for the procedure.

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-RT

AG

DMD-RT-01-301

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-08-01

The Device Identifiers (DI) domain is used to represent the device information details. Characteristics recorded in a DI dataset 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).

Dataset wrap
Namedi
Dataset2

Row

STUDYID

DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

DMD-RT

DI

ABC001

1

DEVTYPE

Device Type

CMR Scanner

2

DMD-RT

DI

ABC001

2

MANUF

Manufacturer

ACME

3

DMD-RT

DI

ABC001

3

TRADENAM

Trade Name

ACME 64

4

DMD-RT

DI

ABC001

4

MODEL

Model Number

CMR540

Fixed properties of devices are represented in the Device Properties (DO) domain. The sponsor chose to keep the software version constant throughout the study.

Dataset wrap
Namedo
Dataset2
Row

STUDYID

DOMAIN

SPDEVID

DOSEQ

DOTESTCD

DOTEST

DOORRES

DOORRESU

1

DMD-RT

DO

ABC001

1

SFTWRNAM

Software Name

CMRRLXU2


2

DMD-RT

DO

ABC001

2

SFTWRVER

Software Version

CMRLX.2


3

DMD-RT

DO

ABC001

3IMAQDIMImage Acquisition Dimensionality3

Changeable properties and parameters of devices are represented in the Device-in-Use (DU) domain. These settings can be linked to records in the CV dataset by their shared SPDEVID and DTC values. For brevity, only 1 subject's parameters are shown.

Dataset wrap
Namedu
SCREENING
Dataset2
Row

STUDYID

DOMAIN

USUBJID

SPDEVID

DUSEQ

DUREFID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

DUDTC

1

DMD-RT

DU

DMD-RT-01-301

ABC001

1

12345678

ANTPLANAnatomical PlaneSAGITTAL
SAGITTAL
3019EXTRAVOLEXTRACELLULAR VOLUME

Pre-contrast

1.2

/s

1.2

1.2/sLEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2023-08-0110DMD-RTCV30110EXTRAVOLEXTRACELLULAR VOLUME

Pre-contrast

1.1

/s

1.1

1.1/sLEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING1


2023-08-01

11
2

DMD-RT

CV30111T1LONGITUDINAL RELAXATION TIME

Post-contrast

1015

400-500s

ms

1015

1015ms

LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1

DU

DMD-RT-01-301

ABC001

2

12345678

PULSSEQPulse SequenceSPGR
SPGR

2023-08-01

3

DMD-RT

DU

DMD-RT-01-301

ABC001

3

12345678

FLIPANGLFlip Angle50deg5050deg
SCREENING

2023-08-01

12
4

DMD-RT

CV30112T2TRANSVERSE RELAXATION TIME

Post-contrast

750

not done post contrast

ms

750

750

ms

LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1

DU

DMD-RT-01-301

ABC001

4

12345678

INTDISTM

Interslice Distance

1mm11mm

2023-08-01

5

DMD-RT

DU

DMD-RT-01-301

ABC001

5

12345678

STHICKSlice Thickness6mm66mm
SCREENING

2023-08-01

13
6

DMD-RT

CV

DU

DMD-RT-01-301
13

ABC001

NATIVE T1 MAPPINGPost-contrast840ms

840

840msCARDIAC MAGNETIC RESONANCE IMAGING1
6

12345678

FLDVIEWField of View32X38cm32X3832X38cm
SCREENING

2023-08-01

14
7

DMD-RT

CV30114EXTRAVOLEXTRACELLULAR VOLUME

Post-contrast

percent or decimal

normal is under 28.5% or .285

abnormal is in the 30s - mid

mid 20s for high

DU

DMD-RT-01-301

ABC001

7

12345678

NUMSLICENumber of Slices12
1212

2023-08-01

8

DMD-RT

DU

DMD-RT-01-301

ABC001

8

12345678

COILSTRCoil Strength1.5T1.51.5T
%%

LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING

2023-08-01

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

Dataset wrap
Nameagrelrec
2023-08-01
Dataset2

Row

STUDYID

DOMAIN

RDOMAIN

USUBJID

AGSEQ

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-LGE

AG

301

1

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

IDVAR

IDVARVAL

RELTYPE

RELID

1

DMD-RT

PR


PRLNKID


ONE

04

2

DMD-RT

CV


CVLNKID


MANY

04

3

DMD-RT

AG


AGLNKID


ONE

04