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
If Yes, complete the following:
Afib/Flutter (Y) Yes (N) No (NK) Not known
Hypercoagulable state (Y) Yes (N) No (NK) Not known
Malignancy (Y) Yes (N) No (NK) Not known
Other risk factors: (Y) Yes (N) No (NK) Not known
If Yes, specify:______
Other CV risk factors:
· MI (Y) Yes (N) No (NK) Not known
· CAD (Y) Yes (N) No (NK) Not known
· HTN (Y) Yes (N) No (NK) Not known
· Hyperlipidemia (Y) Yes (N) No (NK) Not known
· smoking - current or past (Y) Yes (N) No (NK) Not known
· DM (Y) Yes (N) No (NK) Not known
SIGNS and SYMPTOMS
Signs and symptoms of (Y) Yes (N) No (NK) Not known
vascular ischemia or occlusion
If Yes, complete the following:
Acute signs and symptomsa (Y) Yes (N) No (NK) Not known
Chronic signs and symptomsb (Y) Yes (N) No (NK) Not known
Other signs and symptoms (Y) Yes (N) No (NK) Not known
Not known
If Yes, specify: ______
Other, specify______
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
within a peripheral stent? / Location / Date of Test
Day / Time of Test
Hr:Min
00 00-23:59
Y=Yes
N=No / 1= Extremity
2= Aorta
3=Cerebrovascular
4=Renal / Month
Year
Y=Yes
N=No / Y=Yes
N=No
Ultrasound / :
CT / :
MRI / :
Angiography / :
THERAPY
Did the subject require medication? (Y) Yes (N) No (NK) Not known
Was peripheral revascularization performed?If Yes, complete the following: / (Y) Yes (N) No (NK) Not known
Specific Procedure / Procedure Performed / Elective/Urgent / Location / Date of Procedure / Time of Procedure
Y=Yes
N=No / 1=Electived
2=Urgente or Emergentf / 3= Extremity
4=Aorta
5=Cerebrovascular
6=Renal / Day Month Year / Hr:min
00:00-23.59
e.g., Y / 1 / 5 / 01 Jan 11 / 10:35
Bypass surgery
Percutaneous revascularization intervention
Complete a new row if procedure was performed on more than one location.
dElective: 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.
eUrgent: 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).
fEmergent: 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.