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(SMEs add content and update the text below. Thank you.)

Parametric Mapping is a way to measure relaxation time for longitudinal and transverse relaxation time along with extracellular volume. The Native T1 mapping or longitudinal (T1)  relaxation time is the time constant which determines the rate at which excited protons return to equilibrium. It is a measure of the time taken for spinning protons to realign with the external magnetic field. The Native T1 mapping or transverse (T2) relaxation time constant which determines the rate at which excited protons reach equilibrium or go out of phase with each other. It is a measure of the time taken for spinning protons to lose phase coherence among the nuclei spinning perpendicular to the main field.

"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.

...

For extracellular volume - use percent. Normal is under 28.5%; Abnormal is in the mid 30%; mid 20% 

...

Post contrast longitudinal relaxation time is 400s to 500s

Post contrast transverse relaxation time is not done

Stopped here -

  1. Do we need timepoints for the T1 measurement or just the point in time of the final assessment? Not applicable
  2. 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 if this is important)- MOLLI shMOLLI, SHASHA, too much in the weeds. not applicable.
  3. 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? NA
  4. For the location does the intracellular compartment need to be noted? (myocytes, fibroblasts, endothelial cells, smooth muscle cells)
  5. 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) - NA, done in diastole
  6. 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 parametric mapping (T1 mapping, T2 mapping, and extracellular volume) results for USUBJID 301. For brevity, after contrast a limited sample of tests were shown in this example.

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 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 for USUBJID 301. The SPDEVID variable is was used to relate records by the device (in this case, the CMR machine). The Device Identifier (DI) dataset holds the device information details, the Device Properties (DO) dataset holds characteristics of the device that do not vary over the between subjects. The Device-In-Use (DU) dataset holds settings that are set on a device when it is used and may vary between participants.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

CARDIAC MAGNETIC RESONANCE IMAGING

MRI

HEART

2023-08-01

The Cardiovascular System Findings This example cardiovascular system findings (CV) dataset contains physiological and morphological findings related to the cardiovascular system so it holds the assessments from the parametric mapping. The CV dataset below 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.

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 117-138:

Show the

T1 Longitudinal 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".
CVICMOTD
Dataset2

Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVSTAT

CVREASND

CVLOC

CVMETHOD

CVLOBFXL

VISITNUM

VISIT

CVTPT

CVTPTREF

CVDTC

CVICNOIS

CVFOIIND


CVOIQ

1DMD-RTCVDMD-RT-01-301104T1
LONGITUDINAL RELAXATION TIME
Longitudinal Relaxation Time

1315

ms

1315

1315ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
2DMD-RTCVDMD-RT-01-301204T1
LONGITUDINAL RELAXATION TIME
Longitudinal Relaxation Time1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISE
NO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
3DMD-RTCVDMD-RT-01-301304T1
LONGITUDINAL RELAXATION TIME
Longitudinal Relaxation Time

980

ms

980

980ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISE
NO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
4DMD-RTCVDMD-RT-01-301404T2
TRANSVERSE RELAXATION TIME
Transverse Relaxation Time

45

ms4545ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
5DMD-RTCVDMD-RT-01-301504T2
TRANSVERSE RELAXATION TIME
Transverse Relaxation Time

40

ms4040ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
6DMD-RTCVDMD-RT-01-301604T2
TRANSVERSE RELAXATION TIME
Transverse Relaxation Time

48

ms4848ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
11
7DMD-RTCVDMD-RT-01-3017
11
04T1
LONGITUDINAL RELAXATION TIME
Longitudinal Relaxation Time

450

ms450450ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
13
8DMD-RTCVDMD-RT-01-3018
13
04
EXTRAVOLEXTRACELLULAR VOLUME
MYECV

Myocardial Extracellular Volume

25

%2525%



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
LOW NOISENO MOTION DISTORTIONNO FOREIGN OBJECTS

EVALUABLE IMAGE
1
9DMD-RTCVDMD-RT-01-3021
CVALL
CMR TEST RESULTS- add text aournd this - most cases would be one test. May have this occur when the participant is older, and this is how it would be known.
Cardiovascular System Findings




NOT DONE

NON-EVALUABLE IMAGE

HEART

CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1
CONTRAST ADMINISTRATION2023-08-05
HIGH NOISEYES-NOT ACCEPTABLE MOTION DISTORTION
YES FOREIGN OBJECTS

NON-EVALUABLE IMAGE
nsvmeta
10
Domain
DMD-RTCVDMD-RT-01-3031
CVALLCardiovascular System Findings




NOT DONE

UNABLE TO PLACE INTRAVENOUS LINE

HEART

MRI
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05

Nsvmeta
DomainCV
CRF

Variable

Label

Type

Role

Origin

Variable

Label

Type

Role

Origin

CVICNOIS

Image Condition r/t Noise

textNon-standard Record QualifierCRF
CVICMOTDImage Condition r/t Motion DistortiontextNon-standard Record QualifierCRF
CVFOIINDForeign Object on Image IndicatortextNon-standard Record Qualifier

CVOIQOverall Image QualitytextNon-standard Record QualifierCRF

The example Procedure Agents (AG) dataset shows details for the Gadolinium gadolinium-based contrast that was used for the procedure. In this example, the researchers did not collect the time of the contrast.

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-LGERT

AG

DMD-RT-01-301

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-08-01

DI holds The Device Identifiers (DI) domain is used to represent 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 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-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

Fixed properties of devices identified in DI are represented in the Device Properties (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. 

Dataset wrap
Namedo
Dataset2
Row

STUDYID

DOMAIN

SPDEVID

DOSEQ

DOTESTCD

DOTEST

DOORRES

DOORRESU

1

DMD-

LGE

RT

DO

ABC002

ABC001

1

SFTWRNAM

Software Name

CMRRLXU2


2

DMD-

LGE

RT

DO

ABC002

ABC001

2

SFTWRVER

Software Version

CMRLX.2


3

DMD-

LGE

RT

DO

ABC002

ABC001

3IMAQDIMImage Acquisition Dimensionality3

Changeable properties and parameters of the devices identified in DI are represented in the Device-in-Use (DU) domain. These settings could can be linked to the record records in the CV domain dataset 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. 

...

Notes for discussion

...

A minimum of 12 slices were performed, with 20 phases/slice... ?

Imaging protocol - would this be put somewhere? It seems like it would be helpful - would a GRPID be used and then defined somewhere? Or, would it be in the study protocol and not required in the data. If aggregating across studies, it seems like it would be helpful to have it in the data.

Number of excitations =2 for breath hold; 4 to 5 for free breathing (what would this DUTEST be?)

Radiofrequency flip angles were set between 50 degrees and 70 degrees

Grid tag spacing was 7 to 8 mm

TE/TR = 3ms/6.6 ms (by type of machiine)

views per segment = views/segment = 7 to 9  based on machine type (one was = 8)

Data analysis was via "standard planimetry techniques" using semi-automated computer software - this is where Medis is mentioned... is this perhaps what should be in ANMETH?  Do we have a definition for "Feature Tracking" (in the Circum and Long Strain examples)

https://www.jacc.org/doi/abs/10.1016/j.jacc.2008.12.032 - article is for strain - find one for CMR and Parametric mapping .... if different parameters.

Image Removed

Image Removed

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-RT

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

2023-08-01

2
4

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

2
4

12345678

INTDISTM

Interslice Distance

1mm11mm

2023-08-01

3
5

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

3
5

12345678

STHICKSlice Thickness6mm66mm

2023-08-01

4
6

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

7
6

12345678

FLDVIEWField of View32X38cm32X3832X38cm

2023-08-01

5
7

DMD-

LGE

RT

DU

DMD-RT-01-301

ABC001

8
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

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