Date Medical History Taken: - / - /20

Medical History
Page 1 of 6
[Study Name/ID pre-filled]
Site Name: ___________

Subject ID: ___________
Date Medical History Taken: ____/______/20______

mm
dd
yyyy
Does the participant/subject have a history of any medical problems/conditions in the following body systems?
Yes
No (leave rest of form blank)
Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus
of this study. Use only one line per description.
*Use BODY SYSTEM categories for medical history:
Constitutional symptoms (e.g., fever,
Respiratory
weight loss)
Gastrointestinal
Eyes
Genitourinary
Ears, Nose, Mouth, Throat
Musculoskeletal
Cardiovascular
Integumentary (skin and/or breast)
Neurological
Psychiatric
Endocrine
Hematologic/Lymphatic
Allergic/Immunologic
Body
System
Medical History Term
Start Date
(one item per line)
(mm/dd/yyyy)
Cardiovascular
Example: Hypertension
03/99/2009
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
___/____ /20____
Yes
No
___/____ /20____
Stroke Version 1.1
Ongoing?
End Date
(mm/dd/yyyy)
Medical History
Page 2 of 6
Site Name: ___________

Subject ID: ___________
The following interview questions can be used to help make sure a complete medical history is documented.
Has a doctor or other medical professional ever told you that you have or have had the following?
1) Any stroke:
Yes
No (Skip to 2)
Unknown (Skip to 2)
Yes
No (Skip to 1B)
Unknown (Skip to 1B)
i. Number of ischemic strokes:
None
Unknown
ii. Recency of ischemic strokes:
< 3 mos ago
3 mos ago
Unknown
Yes
No (Skip to 2)
Unknown (Skip to 2)
A. Ischemic stroke:
B. Hemorrhagic stroke:
If YES, indicate type(s):
(mos = months)
Intracerebral hemorrhage (ICH)
Subarachnoid hemorrhage (SAH)
Hemorrhage unspecified
Unknown
2) Unruptured aneurysm:
Yes
No
Unknown
3) Dural sinus thrombosis/

cerebral venous thrombosis:
Yes
No
Unknown
4) Transient ischemic attack (TIA):
Yes
No (Skip to 5)
Unknown (Skip to 5)
A. Number of TIAs:
None
B. Recency of TIA:
< 24 hrs ago
24hrs-7dys ago
> 3mos ago
Unknown
5) Arteriovenous malformation (AVM):
Yes
No
Unknown
6) Cavernous malformation:
Yes
No
Unknown
7) Transient monocular blindness:
Yes
No
Unknown
8) Migraine(s):
Yes
No
Unknown
Yes
No
Unknown
9) Carotid stenosis:
Yes
No
Unknown
10) Carotid endarterectomy:
Yes
No
Unknown
Left side
Right side
If YES, migraine(s) with aura:
If YES, indicate location:
Stroke Version 1.1
2-10
>10
7days-3mos ago
Both
Unknown
Unknown
Medical History
Page 3 of 6
Site Name: ___________

Subject ID: ___________
11) Carotid artery stenting:

If YES, indicate location:
Yes
No
Unknown
Left side
Right side
Both
Unknown
12) Seizure episode:
Yes
No
Unknown
13) Epilepsy/ Seizure disorder:
Yes
No
Unknown
14) Central nervous system infection:
Yes
No
Unknown
15) Dementia:
Yes
No
Unknown
16) Current clinical depression:
Yes
No
Unknown
17) Depressive disorder diagnosis:
Yes
No
Unknown
If YES, age experienced first depressive episode/ diagnosed with depression: __ __ years
18) Current clinical anxiety:
Yes
No
Unknown
19) Anxiety disorder diagnosis:
Yes
No
Unknown
20) Psychotic disorder:
Yes
No
Unknown
If YES, indicate type(s):
Schizophrenia
Depression w/ psychotic features
Bipolar disorder
Dementia with psychotic ideation
(choose all that apply)
Other, specify: ________________________________________________________

21) Head trauma:
Yes
No
Unknown
If YES, indicate if head trauma resulted in any of the following: (choose all that apply)
22) Neck trauma:

If YES, indicate recency:
23) Atrial fibrillation (AF)/ flutter:

A. Rheumatic heart disease:
Stroke Version 1.1
Loss of consciousness > 30 minutes
Post traumatic amnesia > 24 hours
Abnormal brain imaging findings
None of the above
Yes
Unknown
No
< 8 days before current stroke/TIA
8 days- 4 weeks ago
> 4 weeks ago
Unknown
Yes
No (Skip to 24)
Unknown (Skip to 24)
Yes
No
Unknown
Medical History
Page 4 of 6
Site Name: ___________

Subject ID: ___________
B. Other cause of AF:
Yes
No
Unknown
If YES, specify other cause: __________________________________________________________________________

24) Coronary artery disease:
Yes
No
Unknown
25) Myocardial infarction:
Yes
No
Unknown
26) Angina:
Yes
No
Unknown
27) Valvular heart disease:
Yes
No
Unknown
28) Cardiac surgery:
Yes
No (Skip to 29)
A. Indicate type(s):
Coronary artery bypass graft (CABG)

Cardiac valve surgery, including non-open surgery (i.e., percutaneous valvuloplasty)
Other, specify:_________________________________________________________
B. Date of most recent cardiac surgery: ___ ___ /___ ___ / 2 0 ___ ___
m
29) Artificial valve:

If YES, indicate type:
Yes
y y
No
Unknown
Biological/ Tissue valve
Mechanical/ Non-tissue valve
Valvuloplasty
Unknown type of valve
30) Coronary stent or PTCA:
Yes
No
Unknown
31) Congestive heart failure:
Yes
No
Unknown
32) Congenital heart disease:
Yes
No
Unknown
33) Cardiac catheritization:
Yes
No
Unknown
2 weeks
> 2 weeks ago
Unknown
34) Peripheral arterial disease:
Yes
No
Unknown
35) Hypertension:
Yes
No
Unknown
No (Skip to 37)
If YES, indicate recency:
If YES, age hypertension first diagnosed: __ __ years

36) Diabetes mellitus:
Yes
A. Age diabetes first diagnosed: __ __ years
Stroke Version 1.1
Medical History
Page 5 of 6
Site Name: ___________
Subject ID: ___________
B. Complications of diabetes:
Nephropathy
Neuropathy
Retinopathy
(choose all that apply)
Other, specify: ____________________
C. Treatment for diabetes: (choose all the apply)
None of the above
Diet
Oral medication
Insulin
None of the above
37) High blood cholesterol /
Hypercholesterolemia:
Yes
If YES, indicate treatment(s): (choose all the apply)
No
Unknown
Diet
Statins
Other medicines
None of the above
38) Hypertriglyceridemia:
Yes
No
Unknown
39) Cancer:
Yes
No (Skip to 40)
Brain
Breast
Colorectal
Endometrial
Esophagus
Lung
Prostate
Renal (kidney)
Skin
Other, specify:___________________________
A. Type(s) of cancer:
B. Did you receive head or neck radiation to treat the cancer?

Yes
No
40) Infection within two weeks:
Yes
No
Unknown
Unknown
If YES, indicate type(s) (choose all that apply):

Respiratory infection
Urinary tract infection (UTI)
Cellulitis
Sepsis
Mastoiditis
Viral gastroenteritis
Fever lasting > 48 hours
Otitis media
Other infection, specify: _____________________________________________________________________________

41) Sickle cell anemia:
Yes
If YES, are blood transfusions used as treatment?

Yes
42) Hypercoagulable disorder:
Yes
No
Unknown
No
Unknown
No
Unknown
If YES, specify type: ___________________________________________________________________________________

43) Bleeding disorder:
Yes
No
Unknown
Stroke Version 1.1
Medical History
Page 6 of 6
Site Name: ___________
Subject ID: ___________
44) Lupus:
Yes
No
Unknown
45) Other connective tissue disease:
Yes
No
Unknown

46) Sleep apnea:
Yes
No
Unknown
If YES, specify type: ___________________________________________________________________________

47) Renal (kidney) failure:
Yes
No
Unknown
48) Nephrotic syndrome:
Yes
No
Unknown
49) Indwelling catheter:
Yes
No
Unknown
50) Chronic liver failure:
Yes
No
Unknown
51) Iron deficiency/ Anemia:
Yes
No
Unknown
52) Inflammatory bowel disease:
Yes
No
Unknown
53) Moyamoya disease (MMD):
Yes
No
Unknown
54) Down syndrome:
Yes
No
Unknown
55) Neurofibromatosis type I (NF1):
Yes
No
Unknown
56) Sturge-Weber syndrome:
Yes
No
Unknown
57) Inborn error metabolism:
Yes
No
Unknown
58) Mitochondrial disease:
Yes
No
Unknown
If YES, do you have/ have you had Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS)?
Yes
No
Unknown
Additional Pediatric-specific Elements

These elements are recommended for pediatric stroke studies.
59) Acquired heart disease:
Yes
No
Unknown
60) Chicken pox in past 12 months:
Yes
No
Unknown
61) Facial Segmental Hemangioma/

PHACE syndrome:
Yes
No
Unknown
Stroke Version 1.1
Medical History CRF Module Instructions
Page 1 of 1
GENERAL INSTRUCTIONS
Medical history data are collected to help verify the inclusion and exclusion criteria (e.g., no history of cognitive
disabilities), ensure the participant/ subject receives the appropriate care and describe the study population.
Typically, the Medical History CRF captures conditions that EVER occurred at some point in time within a
protocol-defined period (e.g. the last 12 months).
SPECIFIC INSTRUCTIONS
Please see the Data Dictionary for definitions for each of the data elements included in this CRF Module.
Date Medical History Taken -- Record the date (and time) the medical history was taken. The date/time
should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours
and minutes, etc.) and in the format acceptable to the study database.
Does this participant/subject have? Choose one. If this question is answered NO then the rest of the
form is blank. If the question is answered YES then the medical history for at least one body system should
be recorded.
Body System Record the appropriate body system for each line of medical history.
Condition/Disease - Record one Medical History term per line. See the data dictionary for additional
information on coding the condition using SNOMED CT.
Start Date Record the date the medical condition/disease started. The date/time should be recorded to
the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and
in the format acceptable to the study database.
Ongoing? Check Yes or No to indicate if the medical condition/disease is still present.
End Date If the condition is not ongoing, record the date (and time) the medical condition/disease
stopped. The date/time should be recorded to the level of granularity known (e.g., year, year and month,
complete date plus hours and minutes, etc.) and in the format acceptable to the study database.
Stroke Version 1.1

Date Medical History Taken: - / - /20

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Medical History

[Study Name/ID pre-filled]

Site Name: ___________