Page History

...

Most patients with aortic aneurysms (AA) are asymptomatic at the time of diagnosis, because the aneurysms are typically discovered incidentally on imaging studies. When an AA reaches medium to large size (>5cm), symptoms may manifest.

Symptoms for TAA are: patients may suffer a local mass effect, such as compression of the trachea or mainstem bronchus (if in the area of the lungs, will cause cough, shortness of breath, wheezing, or recurrent pneumonitis), compression of the esophagus (causing dysphagia), or compression of the recurrent laryngeal nerve (causing hoarseness). Chest pain, generally described as deep and aching or throbbing.

Symptoms of AAA are: pain in the chest, abdomen, lower back, or flank (over the kidneys). A pulsating feeling in the abdomen. A "cold foot" or a black or blue painful toe.

When a patient has abdominal aortic aneurysm of a substantial size, the patient may also have synchronous (at the same time) and metachronous (developed subsequently) thoracic aortic aneurysm. If causes and conditions are present to create an aneurysm in a large-medium size vessel in one place, you are more likely than those without those causes and conditions to have (or develop) another aneurysm somewhere. When a large abdominal aortic aneurysm is diagnosed, screening for TAA is usually recommended. The pressure from the medium to large aneurysm may also cause arterial dissection where the wall of the artery is tore, a "false lumen" forms within the wall of the artery and blood can leak into it - leading to rupture.

Both examples below ask the following questions:

Are AAA and TAA present? If yes, where are they? What is the diameter of the identified aneurysm?
In the presence of large AAA and TAA, arterial dissection is likely. If arterial dissection is observed, where is it? can you classify the dissection based on anatomy?

The figure below describes the general process flow from when a patient complains about the symptoms indicative of TAA and AAA to the diagnosis of TAA and AAA, followed by their subsequent evaluations. This is a summary of all the data collected. Excerpt IncludeTAA and AAA concept map 1TAA and AAA concept map 1

The concept map below transforms the general process figure above into CDISC-compliant format. Note the (TST) and (RES) prefixes are done intentional in the map to show: measurement (--TEST) location vs result (--ORRES) location, respectively.

The patient had undergone a diagnostic intervention, during which a CT scan was done on the chest and abdomen of the subject. The CT scan created images of the thoracic and abdominal regions. An evaluator then reviewed the images of the thoracic region and abdominal region, to find whether aneurysms and arterial dissections are present and where they are located.

Excerpt Include

	TAA and AAA concept map 2
	TAA and AAA concept map 2

Case 1 - Subject has both TAA and AAA

The subject had CT scans performed on the chest and abdomen.

...

Dataset wrap

title	cv.xpt
Name	cv

Rowcaps

Row 1:	I examined the image of the thoracic region (test location) and found an aneurysm in the Thoracic Aorta (result location) spanning from the aortic arch to the descending aorta (result location detail). In this case result location detail further qualifies both ORRES and RESLOC, hence this is a variable qualifier.
Row 2:	I measured the diameter of the aneurysm from aortic arch to the descending aorta (test location).
Row 3:	I examined the image of the thoracic region (test location) and found that the descending aorta (result location) had severely dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area.
Row 4:	The dissected descending aorta (test location) is classified based on the Stanford Aortic Dissection System as type B.
Row 5:	I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (result location), proximal to the iliac bifurcation (result location detail). In this case result location detail is a variable qualifier for the result, I am trying to say that the aneurysm is located in the segment of the infrarenal aorta closer (proximal) to the iliac bifurcation.
Row 6:	I measured the diameter of the infrarenal aortic (test location) aneurysm.
Row 7:	I examined the image of the abdominal region and found that the infrarenal aorta (result location) had dissected.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTEST	CVORRES	CVORRESU	CVLOC	CVLOCDTL	CVMETHOD	VISITNUM	VISIT	CVDTC	CVRESLOC	CVRESLOC Detail
1	ABC	CV	ABC-123	1	1	Aneurysm Indicator	Y		Thoracic region		CT SCAN	1	BASELINE	2020-04-27	Thoracic Aorta	Aortic Arch to Descending aorta
2	ABC	CV	ABC-123	2	1	Aneurysm Diameter	6	cm	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3	2	Dissection Indicator	Y		Thoracic region		CT SCAN	1	BASELINE	2020-04-27	Descending aorta
4	ABC	CV	ABC-123	4	2	Stanford AoD Classification	Stanford B		Descending aorta		CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	3	Aneurysm Indicator	Y		Abdominal region		CT SCAN	1	BASELINE	2020-04-27	Infrarenal aorta	proximal to the iliac bifurcation
6	ABC	CV	ABC-123	6	3	Aneurysm Diameter	7	cm	Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
7	ABC	CV	ABC-123	7		Dissection Indicator	Y		Abdominal region		CT SCAN	1	BASELINE	2020-04-27	Infrarenal aorta	proximal to the iliac bifurcation

Case 2 - Subject has AAA but TAA is not found

The subject had a MRI performed on the torso (trunk).

Dataset wrap

title	cv.xpt
Name	PR

Dataset2

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT		PRLOC1	PRLOC2
1	ABC	PR	ABC-456	1	MRI	TrunkMultiple	BASELINE		Chest	Abdomen

The MRI scan produced images about the thoracic and abdominal regions of the subject. The evaluator then examined the MRI images of the thoracic region and abdominal region, and found the presence of a large AAA, but the absence of TAA.

Dataset wrap

title	cv.xpt
Name	cv

Rowcaps

Row 1:	I examined the MRI image of the thoracic region (test location) and didn't find the presence of an aneurysm.
Row 2:	I examined the MRI image of the abdominal region (test location) and found an aneurysm in the left (Result LAT) renal artery (Result Loc).
Row 3:	I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (Result Loc).
Row 4:	I measured the diameter of the aneurysm in the left renal artery (test location).
Row 5:	I measured the diameter of the aneurysm in the Infrarenal Aorta (test location).

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTEST	CVORRES	CVORRESU	CVLOC	CVLAT	CVMETHOD	VISITNUM	VISIT	CVDTC	CVRESLOC	CVRESLAT
1	ABC	CV	ABC-456	1		Aneurysm Indicator	N		Thoracic Region		MRI	1	BASELINE	2020-04-27
2	ABC	CV	ABC-456	2	1	Aneurysm Indicator	Y		Abdominal Region		MRI	1	BASELINE	2020-04-27	Renal Artery	Left
3	ABC	CV	ABC-456	3	2	Aneurysm Indicator	Y		Abdominal Region		MRI	1	BASELINE	2020-04-27	Infrarenal Aorta
4	ABC	CV	ABC-456	4	1	Aneurysm Diameter	3	cm	Renal Artery	Left	MRI	1	BASELINE	2020-04-27
5	ABC	CV	ABC-456	5	2	Aneurysm Diameter	5	cm	Infrarenal Aorta		MRI	1	BASELINE	2020-04-27

I think what SDTM has not addressed with imaging results is that when you look at the images produced by a procedure, and if your task it to look for the occurrence of a suspected object, what should be considered as the anatomical location of the TEST since you are looking at a 2-dimentaional image/picture. My take is that the images are still representative of, and are about a specific section or part of the body, it allows you to view the entirety of a section or part of the body. In other words, you are looking for a suspected object within a section/part of the body that is made visible to you by the diagnostic procedure. So applying this logic, I outlined the modeling for coronary occlusion data.

...

Lastly, i suppose you could represent aneurysms, arterial dissection, coronary occlusion all as clinical events and use the FACE structure, although i think they are findings about cardiovascular system so CV is a better place for them. However using FACE I have arrived to the same conclusion, see below. What's interesting about the concept map below is that it further shows how anatomical location values vary in --LOC depending on the SDTM class the data go into. As you summarized:

1. Anatomical focus of an intervention - at which part of the body an intervention is being made. (PR)

2. Anatomical manifestation of an event - the part of the body which shows a sign of the event occurring. (CE)

3. Anatomical object of an observation - about which part of the body is the observation being made. (FA/CV)

This shows me that a single --LOC variable for three classes, is an issue.

...

Space shortcuts

Page tree

Versions Compared

Old Version 35

New Version Current

Key

Case 1 - Subject has both TAA and AAA

Case 2 - Subject has AAA but TAA is not found