This example dataset shows the findings of a cardiac magnetic resonance imaging procedure related to late gadolinium enhancement. Different levels of granularity are shown with the various tests and details that might be represented. The research requirements will determine what level of granularity is needed. For example, a study using LGE may require LGE test in their data without the detail of the analysis method. Alternatively, researchers may be interested in understanding if the assessments were done visually or with quantitative methods. If the study includes an assessment of each segment such as with the Segmental Late Gadolinium Enhancement Percentage, there may be interest in representing the quantitative analysis method of "Full-width half maximum" which is one of the types of analysis that may be done. The example provides how to represent this type of information if the researchers are interested in this type of information for the study data. https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-16-45
This example includes example datasets to reflect how the CMR procedure and the contrast would be represented in the data.The Procedures (PR) domain represents diagnostic, preventive, and therapeutic activity. The example PR dataset shows the cardiac magnetic resonance imaging with two different MRI machines, using the SPDEVID to represent the imaging device identifier information provided in the DI dataset below. The ANMETH variable describes the analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g., an image, a genetic sequence) which in this case applies to the CMR imaging. There are machine-centric analysis methods inherit to the type of machine (e.g.,full-width half maximum, 5 standard deviations, 6 standard deviations). https://jcmr-online.biomedcentral.com/articles/10.1186/1532-429X-12-21 These may be of interest for the study and would be represented using the ANMETH variable.
Row 1:
Shows a cardiac MRI for participant DMD-EFLGE-01-101.
Row 2:
Shows a cardiac MRI for participant DMD-EFLGE-01-202 with a different MRI machine. The time of the procedure was not available so only the date is shown in the PRSTDTC variable.
pr.xpt
pr.xpt
Row
STUDYID
DOMAIN
USUBJID
SPDEVID
PRSEQ
PRREFID
PRLNKID
PRTRT
PRFAST
PRSTDTC
1
DMD-EFLGE
PR
DMD-EFLGE-01-101
ABC001
1
12345678
04
CARDIAC MAGNETIC RESONANCE IMAGING
Y
2023-07-01T09:15:00
2
DMD-EFLGE
PR
DMD-EFLGE-01-202
ABC002
1
98765432
05
CARDIAC MAGNETIC RESONANCE IMAGING
N
2023-07-05
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Please add a row column to your dataset.
The Cardiovascular System Findings (CV) domain represents physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. The findings from the CMR procedure for LGE are noted in this example. If LGE was not performed, it would not appear in the dataset.
Row 1:
Shows the late gadolinium enhancement is positive for subject DMD-EFLGE-01-101.
Row 2:
Shows the total late gadolinium enhancement percentage is 40% for subject DMD-EFLGE-01-101.
Rows 3-19:
Show segmental late gadolinium enhancement results for each of the left ventricle segments for subject DMD-EFLGE-01-101.
Row 20:
Shows the late gadolinium enhancement segment count for subject DMD-EFLGE-01-101.
Rows 21-24:
Show the segmental late gadolinium enhancement percentage for each of the positive segments for subject DMD-EFLGE-01-101.
Row 25:
Shows the late gadolinium enhancement is negative for subject DMD-EFLGE-01-202.
The Procedure Agent (AG) represents the agents administered to the participant as part of a procedure or assessment. The example AG dataset shows the timing of the gadolinium-based contrast, GD-DOTA. The time the contrast was given to participant 202 was not available, so only the date is represented in AGSTDTC variable.