Transthoracic Echocardiography, MUGA Scan

Illustrates Domains

PR
AG
CV
RELREC

Illustrates Variables

PRLNKID
PRLOC
AGLNKID
AGROUTE
CVLNKID
CVLOC
CVANMETH
CMIMVIEW
CVRSLSCL
RELID

Content

This is an example showing measures of cardiac function that were obtained at baseline in a heart failure study. LVEF is often measured in patients with heart failure.

The PR domain shows the procedures the subjects underwent. In this example, the use of agents in association with a procedure is represented in the AG domain.

pr.xpt

pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRLNKID	PRTRT	PRCAT	PRLOC	VISITNUM	VISIT	PRSTDTC
1	HF2	PR	HF2-01	1	1	TRANSTHORACIC ECHOCARDIOGRAPHY	CV IMAGING	HEART	1	WEEK 1	2019-06-17T08:10
2	HF2	PR	HF2-02	1	1	TRANSTHORACIC ECHOCARDIOGRAPHY	CV IMAGING	HEART	1	WEEK 1	2019-07-17T08:10
3	HF2	PR	HF2-03	1	1	MUGA SCAN	CV IMAGING	HEART	1	WEEK 1	2019-07-18T08:10
4	HF2	PR	HF2-04	1	1	CONTRAST ENHANCED ECG GATED MRI	CV IMAGING	HEART	1	WEEK 1	2019-10-23T08:25

The following

dataset

shows contrast agents used in the TTE, MUGA scan, and c

ardiac MRI procedures. The cardiac MRI image was performed 15 minutes after the contrast agent was administered.

ag.xpt

ag.xpt

Row	STUDYID	DOMAIN	USUBJID	AGSEQ	AGLNKID	AGTRT	AGCAT	AGDOSE	AGDOSU	AGROUTE	VISITNUM	VISIT	AGSTDTC
1	HF2	AG	HF2-01	1	1	PERFLUTREN LIPID	CONTRAST AGENT	1	mL	INTRAVENOUS BOLUS	1	WEEK 1	2019-06-17T08:10
2	HF2	AG	HF2-02	1	1	SALINE	CONTRAST AGENT	10	mL	INTRAVENOUS BOLUS	1	WEEK 1	2019-07-17T08:10
3	HF2	AG	HF2-03	1	1	Tc-99m	RADIONUCLIDE	680	MBq	INTRAVENOUS BOLUS	1	WEEK 1	2019-07-18T08:10
4	HF2	AG	HF2-04	1	1	GADOBUTROL	CONTRAST AGENT	10	mL	INTRAVENOUS BOLUS	1	WEEK 1	2019-10-23TT08:10

The Cardiovascular System Findings (CV) domain was used to represent the measurements evaluated.

cv.xpt

Row 1:	Shows the qualitative result of estimated ejection fraction of the left ventricle obtained using a TTE.
Row 2:	Shows the fractional area change (FAC) measurement of the right ventricle. FAC can be used for the assessment of all 4 cardiac chambers; as such, the test itself remains general and does not include anatomical locations. The imaging view (placement of the TTE probe on the patient's chest) used to obtain the FAC measurement is the apical 4-chamber view represented in the NSCV.CVIMVIEW. CVLOC is included to indicate which of the 4 heart chambers is being measured in this case.
Row 3:	Shows the estimated ejection fraction of the left ventricle obtained using a TTE.
Row 4:	Shows the myocardial performance index (also known as the Tei index) of the right ventricle. This measurement is unit-less. This test can be used for the assessment of both right and left ventricles; as such, the test itself remains general and does not include a specific anatomical location.
Row 5:	Shows the peak pressure rise rate of the right ventricle. This test can be used to assess tissues and organs other than the heart; as such, the test itself remains general and does not include a specific anatomical location.
Row 6:	Shows the estimated LVEF, obtained using a MUGA scan.
Row 7:	Shows the estimated LVEF, obtained using an ECG-gated MRI with contrast.
Row 8:	Shows the mitral valve function using an ECG-gated MRI with contrast. The grade of 3+ indicates moderate to severe mitral regurgitation.[11,12]

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVCAT	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESNU	CVLOC	CVMETHOD	CVANMETH	VISITNUM	VISIT	CVDTC	CVIMVIEW	CVRSLSCL
1	HF2	CV	HF2-01	1	1	LVEF_E	Left Ventricular Ejection Fraction, Est	LEFT VENTRICULAR FUNCTION	NORMAL						TRANSTHORACIC ECHOCARDIOGRAPHY		2	BASELINE	2019-06-17T08:10		NOMINAL
2	HF2	CV	HF2-01	2	1	FAC	Fractional Area Change	RIGHT VENTRICULAR FUNCTION	42	%	42	42	%	HEART, RIGHT VENTRICLE	TRANSTHORACIC ECHOCARDIOGRAPHY	RVFAC = (RVEDA-RVESA)/RVEDA	2	BASELINE	2019-06-17T08:10	APICAL 4 CHAMBER VIEW
3	HF2	CV	HF2-02	1	1	LVEF_E	Left Ventricular Ejection Fraction, Est	LEFT VENTRICULAR FUNCTION	65	%	65	65	%		TRANSTHORACIC ECHOCARDIOGRAPHY		2	BASELINE	2019-07-17T08:10
4	HF2	CV	HF2-02	2	1	MPI	Myocardial Performance Index	RIGHT VENTRICULAR FUNCTION	0.52		0.52	0.52		HEART, RIGHT VENTRICLE	TRANSTHORACIC ECHOCARDIOGRAPHY	RV MPI = (IVCT + IVRT)/RVET	2	BASELINE	2019-07-17T08:10
5	HF2	CV	HF2-02	3	1	PPRR	Peak Pressure Rise Rate	RIGHT VENTRICULAR FUNCTION	200	mmHg/sec	200	200	mmHg/sec	HEART, RIGHT VENTRICLE	TRANSTHORACIC ECHOCARDIOGRAPHY		2	BASELINE	2019-07-17T08:10
6	HF2	CV	HF2-03	1	1	LVEF_E	Left Ventricular Ejection Fraction, Est	LEFT VENTRICULAR FUNCTION	51	%	51	51	%		MUGA		2	BASELINE	2019-07-18T08:10
7	HF2	CV	HF2-04	1	1	LVEF_E	Left Ventricular Ejection Fraction, Est	LEFT VENTRICULAR FUNCTION	20	%	20	20	%		ECG GATED MRI WITH CONTRAST		2	BASELINE	2019-10-23TT08:25
8	HF2	CV	HF2-04	2	1	CVLREGTS	Cardiac Valvular Regurgitation Severity	MITRAL VALVE FUNCTION	3+		3	3			ECG GATED MRI WITH CONTRAST		2	BASELINE	2019-10-23TT08:25

CV NSV Metadata

Variable	Label	Type	Role	Origin
CVIMVIEW	Imaging View	text	Non-standard Record Qualifier	CRF
CVRSLSCL	Result Scale	text	Non-standard Record Qualifier	CRF

The RELREC dataset shows the relationship between the PR, AG, and CV domains used for this example.

relrec.xpt

relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
1	HF2	PR	PRLNKID	ONE	PRAG
2	HF2	AG	AGLNKID	ONE	PRAG
3	HF2	PR	PRLNKID	ONE	PRCV
4	HF2	CV	CVLNKID	MANY	PRCV