PERIPHERAL ARTERIAL THROMBOEMBOLISM
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as
well as the admission History and Physical Examination findings and the Discharge Summary.
DATE AND TIME OF ONSET OF
:
THROMBOEMBOLISM
Day Month Year Hr:Min(00:00-23:59)
RISK FACTORS
Are there risk factors present?
(Y)
Yes
(N)
No
(NK)
Not known
(Y)
Yes
(N)
No
(NK)
Not known
Hypercoagulable state
(Y)
Yes
(N)
No
(NK)
Not known
Malignancy
(Y)
Yes
(N)
No
(NK)
Not known
If Yes, complete the following:
Afib/Flutter
Other risk factors:
(Y)
Yes
(N)
No
(NK) Not known
If Yes, specify:______________________________________________________________
Other CV risk factors:






MI
CAD
HTN
Hyperlipidemia
smoking - current or past
DM
(Y)
(Y)
(Y)
(Y)
(Y)
(Y)
Yes
Yes
Yes
Yes
Yes
Yes
(N)
(N)
(N)
(N)
(N)
(N)
No
No
No
No
No
No
(NK)
(NK)
(NK)
(NK)
(NK)
(NK)
Not known
Not known
Not known
Not known
Not known
Not known
SIGNS and SYMPTOMS
Signs and symptoms of
vascular ischemia or occlusion
(Y)
Yes
(N)
No
(NK)
Not known
Acute signs and symptomsa
(Y)
Yes
(N)
No
(NK)
Not known
Chronic signs and symptomsb
(Y)
Yes
(N)
No
(NK)
Not known
If Yes, complete the following:
Other signs and symptoms
(Y)
Yes
(N)
No
(NK)
Not known
Not known
If Yes, specify: ______________________________________________________________
Other, specify_________
PERIPHERAL ARTERIAL THROMBOEMBOLISM
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
a
Acute limb ischemia is defined as a sudden decrease in limb perfusion that causes a potential threat to limb viability
(manifested by ischemic rest pain, ischemic ulcers, and/or gangrene) in patients who present within two weeks of the
acute event. The five "P's" of acute ischemia or large vessels include pain, pulselessness, pallor, paresthesias, and
paralysis. In addition, small vessel occlusion can cause the blue toe syndrome.
b
Patients with lower extremity chronic ischemia present with longstanding symptoms of peripheral artery disease that
can include rest pain, which is pain across the base of the metatarsal heads at rest relieved by dependency, or with
tissue loss, which can be ulceration, dry gangrene or wet gangrene. Chronic signs and symptoms may include
claudication with ambulation, nocturnal and/or resting pain, ischemic ulceration, and/or frank gangrene
PERIPHERAL ARTERIAL THROMBOEMBOLISM
Protocol Identifier
Subject Identifier
Test
Performe
d
Diagnostic
Test Name
Visit Description
Treatment Period ABC
Visit XYZ
Consistent with
peripheral
arterial
thromboembolis
m
Y=Yes
N=No
If yes, is
Thromboembolis
m
within a
peripheral stent?
Y=Yes
N=No
Date
of
Test
Day
Location
1= Extremity
2= Aorta
3=Cerebrovascular
4=Renal
Y=Yes
N=No
Time
of
Test
Hr:Mi
n
00 0023:59
Mont
h
Year
Ultrasound
CT
MRI
Angiograph
y
:
:
:
:
THERAPY
Did the subject require medication?
(Y)
Yes
Was peripheral revascularization
(Y)
Yes
(N)
(N)
No
(NK)
No
Not known
(NK)
Not known
performed?
If Yes, complete the following:
Specific
Procedure
Procedure
Performed
Y=Yes
N=No
e.g., Y
Bypass surgery
Percutaneous
revascularization
intervention
Elective/Urgen
t
1=Electived
2=Urgente
or
Emergentf
1
Location
3= Extremity
4=Aorta
5=Cerebrovascula
r
6=Renal
5
Date of
Procedure
Time of
Procedure
Day Month
Year
Hr:min
00:0023.59
01 Jan 11
10:35
PERIPHERAL ARTERIAL THROMBOEMBOLISM
Protocol Identifier
Subject Identifier
Visit Description
Treatment Period ABC
Visit XYZ
Complete a new row if procedure was performed on more than one location.
d
Elective: An elective procedure is one that is scheduled and is performed on a patient with stable disease, or in
whom there is no urgency and/or increased morbidity or mortality associated with a planned procedure.
Urgent: An urgent procedure is one that is not emergent but required to be performed on a timely basis (≤ 24 hrs)
(e.g., a patient who has been stabilized following initial treatment of acute limb ischemia, and there is clinical
consensus that a definitive procedure should occur within the next 24 hours).
e
f
Emergent: A procedure that is performed immediately because of the acute nature of the medical condition (e.g.,
acute limb ischemia, acute aortic dissection), and the increased morbidity or mortality associated with a temporal
delay in treatment.