SDTM. Late Gadolinium Enhancement

This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to late gadolinium enhancement.

The Procedures (PR) dataset is an interventions domain that represents diagnostic, preventive, and therapeutic activity. The PR dataset shows the cardiac magnetic resonance imaging with two different MR machines.

TO DO- Describe the analysis method for LGE - three different methods:

Full-width half maximum
5 standard deviations
6 standard deviations

These are represented in 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.

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.

pr.xpt

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

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The Cardiovascular System Findings (CV) dataset contains 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 (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.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVLOC	CVMETHOD	CVANMETH	VISITNUM	VISIT	CVDTC
1	DMD-EFLGE	CV	101	1	04	LGE	LATE GADOLINIUM ENHANCEMENT	POSITIVE		POSITIVE			LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL	1	SCREENING	2023-07-01
2	DMD-EFLGE	CV	101	2	04	TLGEPR	TOTAL LATE GADOLINIUM ENHANCEMENT PERCENTAGE	40	%	40	40	%	LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	QUANTITATIVE	1	SCREENING	2023-07-01
3	DMD-EFLGE	CV	101	3	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR BASAL ANTERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
4	DMD-EFLGE	CV	101	4	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	POSITIVE		POSITIVE			LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
5	DMD-EFLGE	CV	101	5	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	POSITIVE		POSITIVE			LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
6	DMD-EFLGE	CV	101	6	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR BASAL INFERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
7	DMD-EFLGE	CV	101	7	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR BASAL INFEROLATERAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
8	DMD-EFLGE	CV	101	8	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR ANTEROLATERAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
9	DMD-EFLGE	CV	101	9	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR MID ANTERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
10	DMD-EFLGE	CV	101	10	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	POSITIVE		POSITIVE			LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
11	DMD-EFLGE	CV	101	11	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	POSITIVE		POSITIVE			LEFT VENTRICULAR INFEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
12	DMD-EFLGE	CV	101	12	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR MID INFERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
13	DMD-EFLGE	CV	101	13	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR MID INFEROLATERAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
14	DMD-EFLGE	CV	101	14	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR ANTEROLATERAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
15	DMD-EFLGE	CV	101	15	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR APICAL ANTERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
16	DMD-EFLGE	CV	101	16	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR APICAL SEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
17	DMD-EFLGE	CV	101	17	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR APICAL INFERIOR SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
18	DMD-EFLGE	CV	101	18	04	SGTLGE	SEGMENTAL LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICULAR APICAL LATERAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL
19	DMD-EFLGE	CV	101	19	04	TLGE	TOTAL LGE SEGMENTS	4		4	4		LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL	1	SCREENING	2023-07-01
20	DMD-EFLGE	CV	101	20	04	LGEPER	LATE GADOLINIUM ENHANCEMENT PERCENTAGE	40	%	40	40	%	LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	FULL-WIDTH HALF MAXIMUM	1	SCREENING	2023-07-01
21	DMD-EFLGE	CV	101	21	04	LGEPER	LATE GADOLINIUM ENHANCEMENT PERCENTAGE	20	%	20	20	%	LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	FULL-WIDTH HALF MAXIMUM	1	SCREENING	2023-07-01
22	DMD-EFLGE	CV	101	22	04	LGEPER	LATE GADOLINIUM ENHANCEMENT PERCENTAGE	45	%	45	45	%	LEFT VENTRICULAR MID ANTEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	FULL-WIDTH HALF MAXIMUM	1	SCREENING	2023-07-01
23	DMD-EFLGE	CV	101	23	04	LGEPER	LATE GADOLINIUM ENHANCEMENT PERCENTAGE	20	%	20	20	%	LEFT VENTRICULAR INFEROSEPTAL SEGMENT	CARDIAC MAGNETIC RESONANCE IMAGING	FULL-WIDTH HALF MAXIMUM	1	SCREENING	2023-07-01
24	DMD-EFLGE	CV	202	1	04	LGE	LATE GADOLINIUM ENHANCEMENT	NEGATIVE		NEGATIVE			LEFT VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	VISUAL	1	SCREENING	2023-07-05

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The Procedure Agent (AG) dataset is an interventions domain that contains the agents administered to the participant as part of a procedure or assessment. The AG dataset shows the timing of the Gadolinium based contrast, GD-DOTA. Participant 202 did not have the time the contrast was given available so only the date is represented in AGSTDTC variable.

ag.xpt

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

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