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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

LGE assessments may be done on each of the cardiovascular segments as shown in Figure 1. https://www.ahajournals.org/doi/full/10.1161/hc0402.102975.

Excerpt Include
Figure 1. Left Ventricular Segments
Figure 1. Left Ventricular Segments

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.

Dataset wrap
Namepr
Rowcaps

Row 1:

Shows a cardiac MRI for participant 101.

Row 2:

Shows a cardiac MRI for participant 202 with a different MRI machine. The time of the procedure was not available so only the date is shown in the PRSTDTC variable.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

SPDEVID

PRSEQ

PRREFID

PRLNKID

PRTRT

PRFAST

PRSTDTC

1

DMD-EFLGE

PR

101

ABC001

1

12345678

04

CARDIAC MAGNETIC RESONANCE IMAGING

Y

2023-07-01T09:15:00

2

DMD-EFLGE

PR

202

ABC002

1

98765432

05

CARDIAC MAGNETIC RESONANCE IMAGING

N

2023-07-05

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.

Dataset wrap
Namecv
Rowcaps

Row 1:

Shows the late gadolinium enhancement (LGE) is positive for the overall Left Ventricle for participant 101.

Row 2:

Shows the late gadolinium enhancement (LGE) overall Left Ventricle percentage is 40% for participant 101.

Rows 3-18:

Show the segmental late gadolinium enhancement (LGE) values for each of the left ventricle segments for participant 101.

Row 19:

Shows the total late gadolinium enhancement (LGE) positive segments for participant 101.

Rows 20-23:

Show the segmental late gadolinium enhancement (LGE) percentage for each of the positive LGE segments for participant 101. 

Row 24:

Shows the late gadolinium enhancement (LGE) is negative for participant 202.

Dataset2
Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKID

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVLOC

CVMETHOD

CVANMETH

VISITNUM

VISIT

CVDTC

1DMD-EFLGECV101104LGELATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
2DMD-EFLGECV101204TLGEPERTOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE

40

%

40

40%LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGQUANTITATIVE1VISIT 12023-07-01
3DMD-EFLGECV101304SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENTNEGATIVE

NEGATIVE



LEFT VENTRICULAR BASAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
4DMD-EFLGECV101404SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
5DMD-EFLGECV101504SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
6DMD-EFLGECV101604SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
7DMD-EFLGECV101704SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
8DMD-EFLGECV101804SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR BASAL ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
9DMD-EFLGECV101904SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
10DMD-EFLGECV1011004SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
11DMD-EFLGECV1011104SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

POSITIVE


POSITIVE



LEFT VENTRICULAR INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
12DMD-EFLGECV1011204SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
13DMD-EFLGECV1011304SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID INFEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
14DMD-EFLGECV1011404SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR MID ANTEROLATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
15DMD-EFLGECV1011504SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL ANTERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
16DMD-EFLGECV1011604SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL SEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
17DMD-EFLGECV1011704SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
18DMD-EFLGECV1011804SGTLGESEGMENTAL LATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICULAR APICAL LATERAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
19DMD-EFLGECV1011904LGESEGCLATE GADOLINIUM ENHANCEMENT SEGMENT COUNT

4


4

4
LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-01
20DMD-EFLGECV1012004LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE

40

%

40

40%LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGFULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
21DMD-EFLGECV1012104LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE

20

%

20

20%LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGFULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
22DMD-EFLGECV1012204LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE

45

%

45

45%LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGFULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
23DMD-EFLGECV1012304LGEPERLATE GADOLINIUM ENHANCEMENT PERCENTAGE

20

%

20

20%LEFT VENTRICULAR INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGINGFULL-WIDTH HALF MAXIMUM1VISIT 12023-07-01
24DMD-EFLGECV202104LGELATE GADOLINIUM ENHANCEMENT

NEGATIVE


NEGATIVE



LEFT VENTRICLECARDIAC MAGNETIC RESONANCE IMAGINGVISUAL1VISIT 12023-07-05

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.

Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-EFLGE

AG

101

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-07-01T09:25:00

2

DMD-EFLGE

AG

202

2

04

Gd-DOTA

CONTRAST AGENT

10

mL

SOLUTION

INTRAVENOUS

2023-07-05