(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.
- What is the difference between T1 and T2? Should there be any differences in the data collected for each of these? one is longitudinal relaxation time and the other is transverse relaxation time. The results vary by the physics of the MRI. It shows how the protocns relax after a period of excitation. 1.5 Tesla has a different constant than for another type of scanner. It detects edema/fibrosis. Transverse relaxation time - under 49 change to 40 to 50; 50,60 is high.
- 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.
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 - - 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)
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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 accession number or procedure reference identifier associated with the specific procedure for USUBJID 301. The SPDEVID variable is used to relate records by the device (in this case, the CMR machine).
| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRSTDTC |
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| 1 | DMD-RT | PR | 301 | ABC001 | 1 | 12345678 | 04 | CARDIAC MAGNETIC RESONANCE IMAGING | 2023-08-01 |
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Rows 1-10: | Show the T1 Longitudinal Relaxation Time, the T2 Transverse Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart prior to contrast for CMR. | Rows 11-13: | Show the T1 Longitudinal Relaxation Time, Native T1 Mapping, and Extracellular volume for different segments of the heart after contrast for CMR. |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVSTAT | CVREASND | CVLOC | CVMETHOD | CVLOBFXL | VISITNUM | VISIT | CVDTC |
| CVICNOIS | CVICMOTD | CVFOIIND | CVOIQ |
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| 1 | DMD-RT | CV | 301 | 1 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 2 | DMD-RT | CV | 301 | 2 | T1 | LONGITUDINAL RELAXATION TIME | Pre-contrast | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 3 | DMD-RT | CV | 301 | 3 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | | 980 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 4 | DMD-RT | CV | 301 | 4 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 45 | 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 5 | DMD-RT | CV | 301 | 5 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 40 | 40 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 6 | DMD-RT | CV | 301 | 6 | T2 | TRANSVERSE RELAXATION TIME | | | ms | 48 | 48 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 7 | DMD-RT | CV | 301 | 7 |
| NATIVE T1 MAPPING | Pre-contrast | 1070 | ms | | 1070 | ms |
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| CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | NON-EVALUABLE IMAGE | | 8 | DMD-RT | CV | 301 | 8 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.5 | /s | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 9 | DMD-RT | CV | 301 | 9 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.2 | /s |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 10 | DMD-RT | CV | 301 | 10 | EXTRAVOL | EXTRACELLULAR VOLUME | | | /s | | 1.1 | /s |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 11 | DMD-RT | CV | 301 | 11 | T1 | LONGITUDINAL RELAXATION TIME | | | ms | 450 | 450 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 12 | DMD-RT | CV | 301 | 12 |
| NATIVE T1 MAPPING | Post-contrast | 840 | ms | | 840 | ms |
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| CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 13 | DMD-RT | CV | 301 | 13 | EXTRAVOL | EXTRACELLULAR VOLUME | | | % | 25 | 25 | % | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-01 |
| LOW NOISE | NO MOTION DISTORTION | NO FOREIGN OBJECTS | EVALUABLE IMAGE | | 1 | DMD-RT | CV | 302 | 1 | CVALL | CMR TEST RESULTS | |
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| | | | CARDIAC MAGNETIC RESONANCE IMAGING |
| 1 | SCREENING | 2023-08-05 |
| HIGH NOISE | YES-NOT ACCEPTABLE MOTION DISTORTION | YES FOREIGN OBJECTS | NON-EVALUABLE IMAGE |
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Variable | Label | Type | Role | Origin |
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| CVICNOIS | Image Condition r/t Noise | text | Non-standard Record Qualifier | CRF | | CVICMOTD | Image Condition r/t Motion Distortion | text | Non-standard Record Qualifier | CRF | | CVFOIIND | Foreign Object on Image Indicator | text | Non-standard Record Qualifier | CRF | | CVOIQ | Overall Image Quality | text | Non-standard Record Qualifier | CRF |
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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.
Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-LGE | AG | 301 | 1 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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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).
Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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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 |
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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.
| Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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| 1 | DMD-LGE | DO | ABC002 | | SFTWRNAM | Software Name | CMRRLXU2 |
| | 2 | DMD-LGE | DO | ABC002 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| | 3 | DMD-LGE | DO | ABC002 | 3 | IMAQDIM | Image Acquisition Dimensionality | 3 |
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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.
Notes for discussion Interslice Distance - aligns with "Gap" A minium 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) |
| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DUSEQ | DUREFID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU | DUDTC |
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| 1 | DMD-LGE | DU | 301 | ABC001 | 1 | 12345678 | ANTPLANE | Anatomical Plane | SAGITTAL |
| SAGITTAL |
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| 2023-08-01 | | 2 | DMD-LGE | DU | 301 | ABC001 | 2 | 12345678 | INTDISTM | | 1 | mm | 1 | 1 | mm | 2023-08-01 | | 3 | DMD-LGE | DU | 301 | ABC001 | 3 | 12345678 | STHICK | Slice Thickness | 6 | mm | 6 | 6 | mm | 2023-08-01 | | 4 | DMD-LGE | DU | 301 | ABC001 | 4 | 12345678 | PIXSPCX | X-axis Pixel Spacing | 2 | mm | 2 | 2 | mm | 2023-08-01 | | 5 | DMD-LGE | DU | 301 | ABC001 | 5 | 12345678 | PIXSPCY | Y-axis Pixel Spacing | 2 | mm | 2 | 2 | mm | 2023-08-01 | | 6 | DMD-LGE | DU | 301 | ABC001 | 6 | 12345678 | AQMTRXSZ | Image Acquisition Matrix Size | 256X256 | VOXEL | 256X256 | 256X256 | VOXEL | 2023-08-01 | | 7 | DMD-LGE | DU | 301 | ABC001 | 7 | 12345678 | FLDVIEW | Field of View | 32X38 | cm | 32X38 | 32X38 | cm | 2023-08-01 | | 8 | DMD-LGE | DU | 301 | ABC001 | 8 | 12345678 | NUMSLICE | Number of Slices | 12 |
| 12 | 12 |
| 2023-08-01 | | 9 | DMD-LGE | DU | 301 | ABC001 | 9 | 12345678 | ATTCRCT | Attenuation Correction Type | FBP |
| FBP |
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| 2023-08-01 | | 10 | DMD-LGE | DU | 301 | ABC001 | 10 | 12345678 | DECCORR | Decay Correction Indicator | N |
| N |
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| 2023-08-01 | | 11 | DMD-LGE | DU | 301 | ABC001 | 11 | 12345678 | RANDCORR | Randoms Correction Indicator | N |
| N |
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| 2023-08-01 | | 12 | DMD-LGE | DU | 301 | ABC001 | 12 | 12345678 | RECONDAT | Reconstruction of Raw Data Type | ITERATIVE |
| ITERATIVE |
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| 2023-08-01 |
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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.
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-LGE | PR |
| PRLNKID |
| ONE | 04 | 2 | DMD-LGE | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-LGE | AG |
| AGLNKID |
| ONE | 04 |
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