SDTM. Ejection Fraction

This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every two months. The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.

Rows 1-8:	Show the baseline CMR ejection fraction measurements for participant 101 at VISIT 1.
Rows 9-16:	Show the CMR ejection fraction measurements for participant 101 at VISIT 6.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVLOC	CVMETHOD	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EFLGE	CV	101	1		LVESV	Left Ventricle End Systolic Volume	32	mL	32	32	mL		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
2	DMD-EFLGE	CV	101	2		LVEDV	Left Ventricle End Diastolic Volume	95	mL	95	95	mL		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
3	DMD-EFLGE	CV	101	3	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	67	%	67	67	%		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
4	DMD-EFLGE	CV	101	4	2	CARDOUT	Cardiac Output	5.4	L/min	5.4	5.4	L/min	LEFT, VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
5	DMD-EFLGE	CV	101	5		RVESV	Right Ventricle End Systolic Volume	24	mL	24	24	mL		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
6	DMD-EFLGE	CV	101	6		RVEDV	Right Ventricle End Diastolic Volume	90	mL	90	90	mL		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
7	DMD-EFLGE	CV	101	7	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	74	%	74	74	%		CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
8	DMD-EFLGE	CV	101	8	2	CARDOUT	Cardiac Output	5.6	L/min	5.6	5.6	L/min	RIGHT, VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	1	VISIT 1	2022-05-16	1
9	DMD-EFLGE	CV	101	9		LVESV	Left Ventricle End Systolic Volume	37	mL	37	37	mL		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
10	DMD-EFLGE	CV	101	10		LVEDV	Left Ventricle End Diastolic Volume	94	mL	94	94	mL		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
11	DMD-EFLGE	CV	101	11	2	LVEF_C	Left Ventricular Ejection Fraction, Calculated	60	%	60	60	%		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
12	DMD-EFLGE	CV	101	12	2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	LEFT, VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
13	DMD-EFLGE	CV	101	13		RVESV	Right Ventricle End Systolic Volume	36	mL	36	36	mL		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
14	DMD-EFLGE	CV	101	14		RVEDV	Right Ventricle End Diastolic Volume	93	mL	93	93	mL		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
15	DMD-EFLGE	CV	101	15	2	RVEF_C	Right Ventricular Ejection Fraction, Calculated	61	%	61	61	%		CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355
16	DMD-EFLGE	CV	101	16	2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	RIGHT, VENTRICLE	CARDIAC MAGNETIC RESONANCE IMAGING	6	VISIT 6	2023-06-01	355

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The laboratory test, N-Terminal ProB-type Natriuretic Peptide, is a biomarker used in heart failure and is used with ejection fraction for diagnosis and treatment (https://pubmed.ncbi.nlm.nih.gov/34918487/; https://pubmed.ncbi.nlm.nih.gov/33039447/).

Row 1:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for participant 101 at VISIT 1.
Row 2:	Shows the results for the N-Terminal ProB-type Natriuretic Peptide test at Visit 6.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTRNHI	LBNRIND	LBLOINC	LBSPEC	VISITNUM	VISIT	LBDTC	LBDY
1	DMD-EFLGE	LB	101	1	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	40	pg/mL	0	100	40	40	IU/L	100	40	NORMAL	71425-3	BLOOD	1	VISIT 1	2022-05-16	1
2	DMD-EFLGE	LB	101	2	2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	900	pg/mL	0	100	900	900	IU/L	100	900	HIGH	71425-3	BLOOD	6	VISIT 6	2023-06-01	355

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The relationship between CV and LB is represented in the Related Records dataset (RELREC). For more information on relating records, see the SDTMIG v3.4, Section 8.2.

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relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	DMD-EFLGE	CV		CVLNKID		MANY	2
2	DMD-EFLGE	LB		LBLNKID		ONE	2

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