CV-Imaging Example 1, Cardiac Valvular Abnormality

TU Domain Definition and Scope

The Tumor/Lesion domains (TU, TR) represent data collected in clinical trials where sites of disease (e.g., tumors/lesions/locations of interest, lymph nodes, organs of interest in the assessment of the disease) are identified and then repeatedly measured/assessed at subsequent time points and often used in an evaluation of disease response(s).

Tumor/Lesion Identification (TU)

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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	VISIT
1	ABC	PR	ABC-456	1	TRANSTHORACIC ECHOCARDIOGRAPHY	BASELINE

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The below examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation (CV).

Rows 1-3:	Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis.
Rows 4-5:	Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TULOC	TUORRES	TUSTRESC	TURESLOC	TUMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	TU	ABC-456	1		LESIONIND	Lesion Indicator	HEART	Y			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	TU	ABC-456	2	mv calcification	ABNEXAM	Examination for Abnormality	HEART	Valvular Calcification	Valvular Calcification	Mitral Valve Annulus	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
3	ABC	TU	ABC-456	3	mv stenosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis	Valvular Stenosis	Mitral Valve	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

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cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVSTRESC	CVRESLOC	CVRESLOC Detail	CVMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	CV	ABC-456	1			Abnormality Indicator	HEART	Y				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	CV	ABC-456	2	mv regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation	Blood Regurgitation	Mitral Valve	From left ventricle into the left atrium	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

Dataset Debug Messages

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Alternatively modeling all of the above in CV:

Rows 1-4:	Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis, as well as regurgitation.
Rows 5-8:	Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.
Rows 9-11:	Examination of the heart indicates flail aortic cusp and aortic valve stenosis, as well as regurgitation.
Rows 5-8:	Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	SCSTRESU	CVRESLOC	CVRESLOC Detail	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-456	1			ABNIND	Abnormality Indicator	HEART	Y		Y	Y				TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	CV	ABC-456	2		mv calcification	ABNEXAM	Examination for Abnormality	HEART	Valvular Calcification		Valvular Calcification	Valvular Calcification		Mitral Valve Annulus		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
3	ABC	CV	ABC-456	3	1	mv stennosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis		Valvular Stenosis	Valvular Stenosis		Mitral Valve		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
4	ABC	CV	ABC-456	4	2	mv regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation		Blood Regurgitation	Blood Regurgitation		Mitral Valve	From left ventricle into the left atrium	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
5	ABC	CV	ABC-456	5		mv regurgitation	EFFRGOA	Effective Regurgitant Orifice Area		26	mm2	26	26	mm2			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
6	ABC	CV	ABC-456	6		mv regurgitation	MVRGF	Regurgitant Fraction		35	%	35	35	%			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
7	ABC	CV	ABC-456	7		mv regurgitation	MVRGF	Regurgitant Volume		36	mL/beat	36	36	mL/beat			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
8	ABC	CV	ABC-456	8		mv regurgitation	MVVCA	Vena Contracta Area		26	mm2	26	26	mm2			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
9	ABC	CV	ABC-456	2		av cusp	ABNEXAM	Examination for Abnormality	HEART	Flail Cusp		Flail Cusp	Flail Cusp		Aortic Valve, Right Coronary Cusp		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
10	ABC	CV	ABC-456	3		av stenosis	ABNEXAM	Examination for Abnormality	HEART	Valvular Stenosis		Valvular Stenosis	Valvular Stenosis		Aortic Valve		TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
11	ABC	CV	ABC-456	4	3	av regurgitation	ABNEXAM	Examination for Abnormality	HEART	Blood Regurgitation		Blood Regurgitation	Blood Regurgitation		Aortic Valve	From aorta to left ventricle	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
12	ABC	CV	ABC-456	5		av regurgitation	EFFRGOA	Effective Regurgitant Orifice Area		15	mm2	15	15	mm2			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
13	ABC	CV	ABC-456	6		av regurgitation	MVRGF	Regurgitant Fraction		20	%	20	20	%			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
14	ABC	CV	ABC-456	7		av regurgitation	MVRGF	Regurgitant Volume		277	mL/beat	27	27	mL/beat			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
15	ABC	CV	ABC-456	8		av regurgitation	MVVCA	Vena Contracta Area		22	mm2	22	22	mm2			TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27

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The following example shows how to model severity assessments of the identified lesions and abnormalities based on peer-reviewed, validated and published instruments (either copyrighted or public domain). Note these tests were originally created as a CVTESTs, if users are using SDTMIG versions prior to 3.4. Per SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.

Row 1:	Mitral valve stenosis is moderate.
Row 2:	Mitral valve regurgitation is severe.

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rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTEST	RSCAT	RSORRES	VISITNUM	VISIT	RSDTC
1	ABC	RS(CC)	ABC-456	1	1	VSC-Cardiac Valvular Stenosis Severity: Mitral Valve	VALVE STENOSIS CLASSIFICATION 2009 VERSION	Moderate	1	BASELINE	2020-04-27
2
3	ABC	RS(CC)	ABC-456	3	2	SNVRC-Cardiac Valvular Regurgitation Severity	SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003	Moderate	1	BASELINE	2020-04-27

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