CV-endpoint Example 2, Coronary Lesion

Collection Date	Collection Date TUDAT TUDTC	_________________
	Anatomical Part or Region Shown by the Image TULOC Hidden/pre-populated	CORONARY ARTERY SYSTEM
	Lesion Identification Test Name TUTEST Hidden/pre-populated	Lesion Indicator <TUTEST codelist>
	Was there a lesion present based on the assessment of the image? TUORRES	Yes No <Y/N codelist>
	Lesion Identification Test Name TUTEST Hidden/pre-populated	Examination for Abnormality <TUTEST codelist>
Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.	Lesion Type TUORRES TUORRES when TUTEST = ABNEXAM	_________________
If this location is a graft (or transplant), enter the name of the native tissue, organ or blood vessel on which the graft is built (or in which the transplant is implanted).	What was the location of the lesion based on the assessment of the image? TURESLOC TURESLOC when TUTEST = ABNEXAM	_________________ <LOC codelist>
Check "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel.	Indicate whether the located lesion is in a graft or transplant. TURLGFFL NSTU.TURLGFFL	Yes
	If applicable, indicate the laterality of the location of the lesion. TURESLAT TURESLAT when TUTEST = ABNEXAM	_________________ <LAT codelist>
	If applicable, provide more detail of the location of the lesion. TURESLDL TURLODTL when TUTEST = ABNEXAM	_________________
Sponsor-specified	What was the Lesion ID? TULNKID TULNKID, TRLNKID, RSLNKID	_________________
	Coronary Lesion Severity Clinical Classification RSCAT Hidden/pre-populated	ACC/AHA CLASSIFICATION OF CORONARY LESIONS
	What was the severity of the coronary lesion? RSTEST RSTEST when RSTEST = ACAH0101	Type A Type B Type C

Order	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	Controlled Terminology Codelist Name	Implementation Notes	Permissible Values	Pre-populated Value	Query Display	List Style	Hidden
1	text	TUDAT	Collection Date		Collection Date	TUDTC	N/A				Prompt
2	text	TULOC	What was the anatomical region shown by the imaging procedure?	Anatomical Part or Region Shown by the Image		TULOC		This is the general anatomical part or region made available for assessment by the imaging procedure.		CORONARY ARTERY SYSTEM			Y
3	text	TUTEST	What was the lesion identification test name?	Lesion Identification Test Name	Record the name of the TU test, if not printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.	TUTEST	(TUTEST)	Required to identify to which test the result relates. It is recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.		Lesion Indicator			Y
4	text	TUORRES	Was there a lesion present based on the assessment of the image?	Presence of Lesion		TUORRES	(Y/N)		Yes;No		redio
5	text	TUTEST	What was the lesion identification test name?	Lesion Identification Test Name	Record the name of the TU test, if not printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.	TUTEST	(TUTEST)	Required to identify to which test the result relates. It is recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.		Examination for Abnormality			Y
6	text	TUORRES	What was the type of lesion observed based on the assessment of the image?	Lesion Type	Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.	TUORRES when TUTEST = ABNEXAM					Prompt
7	text	TURESLOC	What was the location of the lesion based on the assessment of the image?	Result Anatomical Location	If this location is a graft (or transplant), enter the name of the native tissue, organ or blood vessel on which the graft is built (or in which the transplant is implanted).	TURESLOC when TUTEST = ABNEXAM	(LOC)
8	text	TURLGFFL	Indicate whether the located lesion is in a graft or transplant.	Graft Result Location Flag	Check "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel.	NSTU.TURLGFFL			Yes			checkbox
9	text	TURESLAT	If applicable, indicate the laterality of the location of the lesion.	Result Location Laterality		TURESLAT when TUTEST = ABNEXAM	(LAT)
10	text	TURESLDL	If applicable, provide more detail of the location of the lesion.	Result Location directionality		TURLODTL when TUTEST = ABNEXAM	N/A
11	text	TULNKID	What was the Lesion ID?	Lesion ID	Sponsor-specified	TULNKID, TRLNKID, RSLNKID	N/A	This variable is used to provide a unique code for each identified lesion in order to link records across related domains (TU, TR, RS).
12	text	RSCAT	Record the clinical classification used for the assessment of Coronary lesion severity.	Coronary Lesion Severity Clinical Classification		RSCAT				ACC/AHA CLASSIFICATION OF CORONARY LESIONS			Y
13	text	RSTEST	What was the severity of the coronary lesion?	Coronary Lesion Severity		RSTEST when RSTEST = ACAH0101		If the instrument is considered as a clinical classification (i.e. validated, peer-reviewed public domain or copyrighted instrument), use the combined RS/CC domain and follow CC controlled terminology business rules.	Type A; Type B; Type C			radio

Shows the identification of two coronary lesions and their associated locations.

Row 1:	Shows one or more lesions have been identified in the CORONARY ARTERY SYSTEM.
Row 2:	Shows the location of lesion 1.
Row 3:	Shows the location of lesion 2.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TULOC	TUORRES	TUSTRESC	TURESLOC	TURESDIR	TUMETHOD	TUEVAL	VISITNUM	VISIT	TUDTC
1	TUDY01	TU	40912	1		LESIONIND	Lesion Indicator	CORONARY ARTERY SYSTEM	Y	Y			CORONARY ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	2	Lesion 1	ABNEXAM	Examination for Abnormality	CORONARY ARTERY SYSTEM	IDENTIFIED	IDENTIFIED	CORONARY ARTERY, RIGHT	PROXIMAL	CORONARY ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
3	TUDY01	TU	40912	3	Lesion 2	ABNEXAM	Examination for Abnormality	CORONARY ARTERY SYSTEM	IDENTIFIED	IDENTIFIED	LEFT MAIN CORONARY ARTERY BIFURCATION		CORONARY ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07

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Shows the assessment of the severity of the coronary arterial lesions, based on the clinical classification ACC/AHA CLASSIFICATION OF CORONARY LESIONS.

Row 1:	Shows lesion 1 is considered as type A according to the ACC/AHA classification.
Row 2:	Shows lesion 2 is considered as type B1 according to the ACC/AHA classification.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	VISITNUM	VISIT	TUDTC
1	TUDY01	RS	40912	1	Lesion 1	ACAH0101	ACAH01-ACC/AHA Classification of Coronary Lesions Type	ACC/AHA CLASSIFICATION OF CORONARY LESIONS	Type A	Type A	INVESTIGATOR	2	VISIT 1	2007-02-07
1	TUDY01	RS	40912	1	Lesion 2	ACAH0101	ACCAHA01-ACC/AHA Classification of Coronary Lesions Type	ACC/AHA CLASSIFICATION OF CORONARY LESIONS	Type B1	Type B1	INVESTIGATOR	2	VISIT 1	2007-02-07

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