(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.
"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.
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For extracellular volume - use percent. Normal is under 28.5%; Abnormal is in the mid 30%; mid 20%
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Post contrast longitudinal relaxation time is 400s to 500s
Post contrast transverse relaxation time is not done
Stopped here -
- Do we need timepoints for the T1 measurement or just the point in time of the final assessment?
- 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)
- 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?
- 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?
- For the location does the intracellular compartment need to be noted? (myocytes, fibroblasts, endothelial cells, smooth muscle cells)
- 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)
- 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 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. SPDEVID was used to link this PR record to the device records.
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRLOC | PRSTDTC |
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1 | DMD-RT | PR | DMD-RT-01-301 | ABC001 | 1 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING |
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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.
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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 CMRlongitudinal 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".
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST |
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CVCATPre-contrast | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVSTAT | CVREASND | CVLOC | CVMETHOD | CVLOBFXL | VISITNUM | VISIT | CVTPT | CVTPTREF | CVDTC |
| CVOIQ |
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1 | DMD-RT | CV | DMD-RT-01-301 | 1 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | Longitudinal Relaxation Time | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | 2 | DMD-RT | CV | DMD-RT-01-301 | 2 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | Pre-contrast | Longitudinal Relaxation Time | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 3 | DMD-RT | CV | DMD-RT-01-301 | 3 | 04 | T1 |
LONGITUDINAL RELAXATION TIME | | Longitudinal Relaxation Time | | ms | | 980 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 4 | DMD-RT | CV | DMD-RT-01-301 | 4 | 04 | T2 |
TRANSVERSE RELAXATION TIME | | Transverse Relaxation Time | | ms | 45 | 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 5 | DMD-RT | CV | DMD-RT-01-301 | 5 | 04 | T2 |
TRANSVERSE RELAXATION TIME | | Transverse Relaxation Time | | ms | 40 | 40 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | SCREENINGPre-contrast | 2023-08-01 |
| EVALUABLE IMAGE | 6 | DMD-RT | CV | DMD-RT-01-301 | 6 | 04 | T2 |
TRANSVERSE RELAXATION TIME | Transverse Relaxation Time | | ms | 48 | 48 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 7 | DMD-RT | CV | DMD-RT-01-301 | 7 | 04 | NATIVE MAPPINGPre-contrast | | Longitudinal Relaxation Time | | 107010701070CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 8 | DMD-RT | CV | DMD-RT-01-301 | 8 | EXTRAVOLEXTRACELLULAR VOLUME | | | /s | | 1.5 | MYECV | Myocardial Extracellular Volume | | % | 25 | 25 | % | /s | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | 9 | DMD-RT | CV |
301 | 9 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.2 | /s | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-08-01 | DMD-RT-01-302 | 1 |
| CVALL | Cardiovascular System Findings |
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| | | | MRI |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION | 2023-08-05 |
| NON-EVALUABLE IMAGE | 10 |
10 | DMD-RT | CV | 301 | 10 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.1 | /s | LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-08-01 | 11301 | 11 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | 450 | 450 | ms | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-08-01 | DMD-RT-01-303 | 1 |
| CVALL | Cardiovascular System Findings |
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| | UNABLE TO PLACE INTRAVENOUS LINE | | MRI |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION |
12 | DMD-RT | CV | 301 | 12 | NATIVE T1 MAPPING | Post-contrast | 840 | ms | | 840 | ms | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING0113 |
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DMD-RT | 30113EXTRAVOLEXTRACELLULAR VOLUME | | | % | 25 | 25 | % | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-08-01 | Role | Origin |
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CVOIQ | Overall Image Quality | text | Non-standard Record Qualifier | CRF |
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The example Procedure Agents (AG) dataset shows details for the gadolinium-based contrast used for the procedure.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.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGLNKID | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-LGERT | AG | DMD-RT-01-301 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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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).
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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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 |
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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.
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Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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1 | DMD- | LGEABC002ABC001 | | SFTWRNAM | Software Name | CMRRLXU2 |
| 2 | DMD- | LGEABC002ABC001 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| 3 | DMD- | LGEABC002ABC001 | 3 | IMAQDIM | Image Acquisition Dimensionality | 3 |
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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.
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DUSEQ | DUREFID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU | DUDTC |
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1 | DMD- | LGERT | DU | DMD-RT-01-301 | ABC001 | 1 | 12345678 | ANTPLANEANTPLAN | Anatomical Plane | SAGITTAL |
| SAGITTAL | 20200221LGERT | DU | DMD-RT-01-301 | ABC001 | 2 | 12345678 | INTDISTMInterslice Distance1mm | 1 | 1 | mm | 2020-02-21LGERT | DU | DMD-RT-01-301 | ABC001 | 3 | 12345678 | STHICKSlice Thickness1mm11mm20200221LGERT | DU | DMD-RT-01-301 | ABC001 | 4 | 12345678 |
PIXSPCX | X-axis Pixel Spacing | 22220200221LGERT | DU | DMD-RT-01-301 | ABC001 | 5 | 12345678 |
PIXSPCY | Y-axis Pixel Spacing | 22220200221LGE7 | DMD-LGE | DU | 301 | ABC001 | 6 | 12345678 | AQMTRXSZ | Image Acquisition Matrix Size | 256X256 | VOXEL | 256X256 | 256X256 | VOXEL | 2020-02-21 | 76 | 12345678 | FLDVIEW | Field of View | 280X280mm280X280280X280mm202002218LGE87 | 12345678 | NUMSLICE | Number of Slices | 125125125202002219LGE10 | DMD-LGE | DU | 301 | ABC001 | 9 | 12345678 | ATTCRCT | Attenuation Correction Type | FBP | FBP | 2020-02-21 | 10DECCORR | Decay Correction Indicator | N | N | 2020-02-21 | 11 | DMD-LGE | DU | 301 | ABC001 | 11 | 12345678 | RANDCORR | Randoms Correction Indicator | N | N | 2020-02-21 | 12 | DMD-LGE | DU | 301 | ABC001 | 12 | 12345678 | RECONDAT | Reconstruction of Raw Data Type | ITERATIVE | ITERATIVE | 2020-02-21 | COILSTR | Coil Strength | 1.5 | T | 1.5 | 1.5 | T | 2023-08-01 |
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The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-LGERT | PR |
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| ONE | 04 | 2 | DMD-LGERT | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGERT | AG |
| AGLNKID |
| ONE | 04 |
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