ID

20302

Description

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Visit 1 (Month 0) Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Keywords

Versions (2)
  1. 2/15/17 2/15/17 -
  2. 2/20/17 2/20/17 -
Uploaded on

February 20, 2017

DOI

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License

Creative Commons BY 4.0
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Visit 1 Month 0 Physical Examination Pregnancy Test Scale ECG Neurological Assessment Modified Rankin Scale PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

English

Visit 1 Month 0 Physical Examination Pregnancy Test Scale ECG Neurological Assessment Modified Rankin Scale PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms  
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Height
Description

Body Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0031809
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Abdominal girth (Waist Circumference)
Description

Abdominal girth

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0232501
cm
Blood pressure systolic after 5 minutes sitting/supine
Description

Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic after 5 minutes sitting/supine
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure position
Description

Blood pressure position

Data type

integer

Alias
UMLS CUI [1]
C1828063
Heart rate
Description

Heart rate

Data type

float

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Negative
Description

Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0205160
Positive (patient is NOT eligible for trial)
Description

Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1446409
Not applicable (patient is male, or female who is post-menopausal or surgically sterilised)
Description

Not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1272460
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Has an ECG been performed?
Description

ECG perfomance

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
Description

If Yes

Data type

text

Alias
UMLS CUI [1]
C1830427
UMLS CUI [2]
C1549755
UMLS CUI [3,1]
C0013798
UMLS CUI [3,2]
C0011008
Are there any pathological Q waves?
Description

Pathological Q waves

Data type

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C1521733
if Yes, in which leads (indicate all that apply)
Description

if Yes, in which leads

Data type

integer

Alias
UMLS CUI [1]
C0179504
Does the ECG show left ventricular hypertrophy (LVH)?
Description

ECG shows LVH

Data type

boolean

Alias
UMLS CUI [1]
C0149721
If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
Description

Modified Cornell Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C0025102
Neurological Assessment - NIH Stroke Scale
Description

Neurological Assessment - NIH Stroke Scale

Alias
UMLS CUI-1
C1697238
Level of consciousness
Description

Level of consciousness

Data type

integer

Alias
UMLS CUI [1]
C2234452
LOC questions (Month, age)
Description

LOC questions (Month, age)

Data type

integer

Alias
UMLS CUI [1]
C2234453
LOC commands (Open, close eyes, make fist, let go)
Description

LOC commands

Data type

integer

Alias
UMLS CUI [1]
C2234454
Best gaze (Eyes open patient follows examiner´s finger or face)
Description

Best gaze

Data type

integer

Alias
UMLS CUI [1]
C2234455
Visual (Introduce visual stimulus/threat to patient´s visual field quadrants)
Description

Visual

Data type

integer

Alias
UMLS CUI [1]
C2234456
Facial Palsy (Show teeth, raise eyebrows and squeeze eyes shut)
Description

Facial Palsy

Data type

integer

Alias
UMLS CUI [1]
C2234457
Motor Arm-Left (Elevate extremity 90° and score drift/movement)
Description

Motor Arm-Left

Data type

integer

Alias
UMLS CUI [1]
C3862776
Motor Arm-Right (Elevate extremity 90° and score drift/movement)
Description

Motor Arm-Right

Data type

integer

Alias
UMLS CUI [1]
C3862775
Motor Leg-Left (Elevate extremity 30° and score drift/movement)
Description

Motor Leg-Left

Data type

integer

Alias
UMLS CUI [1]
C3862774
Motor Leg-Right (Elevate extremity 30° and score drift/movement)
Description

Motor Leg-Right

Data type

integer

Alias
UMLS CUI [1]
C3862773
Limb ataxia (Finger-nose, heel down shin)
Description

Limb ataxia

Data type

integer

Alias
UMLS CUI [1]
C2234460
Sensory (Pin prick to face, arm, trunk, and leg compare side to side)
Description

Sensory

Data type

integer

Alias
UMLS CUI [1]
C2234461
Best language (Name items, describe a picture and read sentences)
Description

Best language

Data type

integer

Alias
UMLS CUI [1]
C2234462
Dysarthria (Evaluate speech clarity by patient repeating listed words)
Description

Dysarthria

Data type

integer

Alias
UMLS CUI [1]
C2234463
Extinction and Inattention (Use information from prior to testing to identify neglect or double stimuli testing)
Description

Extinction and Inattention

Data type

integer

Alias
UMLS CUI [1]
C2234464
Modified Rankin Scale
Description

Modified Rankin Scale

Alias
UMLS CUI-1
C2984908
For the qualifying ischemic stroke, please fill in the current Modified Rankin Scale below. (Indicate only one)
Description

Modified Rankin Scale

Data type

integer

Alias
UMLS CUI [1]
C2984908
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Similar models

Visit 1 Month 0 Physical Examination Pregnancy Test Scale ECG Neurological Assessment Modified Rankin Scale PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Body Height
Item
Height
float
C0031809 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Abdominal girth
Item
Abdominal girth (Waist Circumference)
float
C0232501 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood pressure systolic after 5 minutes sitting/supine
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood pressure diastolic after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1])
Item
Blood pressure position
integer
C1828063 (UMLS CUI [1])
Blood pressure position
Code List
Blood pressure position
CL Item
Sitting (1)
CL Item
Supine (2)
Heart rate
Item
Heart rate
float
C0018810 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Negative
Item
Negative
boolean
C0032976 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
Positive
Item
Positive (patient is NOT eligible for trial)
boolean
C0032976 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Not applicable
Item
Not applicable (patient is male, or female who is post-menopausal or surgically sterilised)
boolean
C0032976 (UMLS CUI [1,1])
C1272460 (UMLS CUI [1,2])
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG perfomance
Item
Has an ECG been performed?
boolean
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
If Yes
Item
If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
text
C1830427 (UMLS CUI [1])
C1549755 (UMLS CUI [2])
C0013798 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
Pathological Q waves
Item
Are there any pathological Q waves?
boolean
C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
Item
if Yes, in which leads (indicate all that apply)
integer
C0179504 (UMLS CUI [1])
if Yes, in which leads
Code List
if Yes, in which leads (indicate all that apply)
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
aVF (4)
CL Item
V1 (5)
CL Item
V2 (6)
CL Item
V3 (7)
CL Item
V4 (8)
CL Item
V5 (9)
CL Item
V6 (10)
ECG shows LVH
Item
Does the ECG show left ventricular hypertrophy (LVH)?
boolean
C0149721 (UMLS CUI [1])
Modified Cornell Criteria
Item
If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
boolean
C0521093 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
Item Group
Neurological Assessment - NIH Stroke Scale
C1697238 (UMLS CUI-1)
Item
Level of consciousness
integer
C2234452 (UMLS CUI [1])
Level of consciousness
Code List
Level of consciousness
CL Item
Alert (0)
CL Item
Drowsy (1)
CL Item
Stuporous (requires repeated stimuli) (2)
CL Item
Comatose (Reflex responses only) (3)
Item
LOC questions (Month, age)
integer
C2234453 (UMLS CUI [1])
LOC questions (Month, age)
Code List
LOC questions (Month, age)
CL Item
Both correct (0)
CL Item
One correct (1)
CL Item
Incorrect (2)
Item
LOC commands (Open, close eyes, make fist, let go)
integer
C2234454 (UMLS CUI [1])
LOC commands
Code List
LOC commands (Open, close eyes, make fist, let go)
CL Item
Obeys (0)
CL Item
Obeys one correctly (1)
CL Item
Incorrect (2)
Item
Best gaze (Eyes open patient follows examiner´s finger or face)
integer
C2234455 (UMLS CUI [1])
Best gaze
Code List
Best gaze (Eyes open patient follows examiner´s finger or face)
CL Item
Normal (0)
CL Item
Partial gaze palsy (1)
CL Item
Forced deviation (2)
Item
Visual (Introduce visual stimulus/threat to patient´s visual field quadrants)
integer
C2234456 (UMLS CUI [1])
Visual
Code List
Visual (Introduce visual stimulus/threat to patient´s visual field quadrants)
CL Item
No loss (0)
CL Item
Partial hemianopia (1)
CL Item
Complete hemianopia (2)
CL Item
Bilateral hemianopia (3)
Item
Facial Palsy (Show teeth, raise eyebrows and squeeze eyes shut)
integer
C2234457 (UMLS CUI [1])
Facial Palsy
Code List
Facial Palsy (Show teeth, raise eyebrows and squeeze eyes shut)
CL Item
Normal (0)
CL Item
Minor asymmetry (1)
CL Item
Partial (lower face paralysis) (2)
CL Item
Complete (3)
Item
Motor Arm-Left (Elevate extremity 90° and score drift/movement)
integer
C3862776 (UMLS CUI [1])
Motor Arm-Left
Code List
Motor Arm-Left (Elevate extremity 90° and score drift/movement)
CL Item
No Drift (0)
CL Item
Drift (1)
CL Item
Some effort against gravity (2)
CL Item
No effort against gravity (3)
CL Item
No Movement (4)
CL Item
Amputation, joint fusion (5)
Item
Motor Arm-Right (Elevate extremity 90° and score drift/movement)
integer
C3862775 (UMLS CUI [1])
Motor Arm-Left
Code List
Motor Arm-Right (Elevate extremity 90° and score drift/movement)
CL Item
No Drift (0)
CL Item
Drift (1)
CL Item
Some effort against gravity (2)
CL Item
No effort against gravity (3)
CL Item
No Movement (4)
CL Item
Amputation, joint fusion (5)
Item
Motor Leg-Left (Elevate extremity 30° and score drift/movement)
integer
C3862774 (UMLS CUI [1])
Motor Arm-Left
Code List
Motor Leg-Left (Elevate extremity 30° and score drift/movement)
CL Item
No Drift (0)
CL Item
Drift (1)
CL Item
Some effort against gravity (2)
CL Item
No effort against gravity (3)
CL Item
No Movement (4)
CL Item
Amputation, joint fusion (5)
Item
Motor Leg-Right (Elevate extremity 30° and score drift/movement)
integer
C3862773 (UMLS CUI [1])
Motor Arm-Left
Code List
Motor Leg-Right (Elevate extremity 30° and score drift/movement)
CL Item
No Drift (0)
CL Item
Drift (1)
CL Item
Some effort against gravity (2)
CL Item
No effort against gravity (3)
CL Item
No Movement (4)
CL Item
Amputation, joint fusion (5)
Item
Limb ataxia (Finger-nose, heel down shin)
integer
C2234460 (UMLS CUI [1])
Limb ataxia
Code List
Limb ataxia (Finger-nose, heel down shin)
CL Item
Absent (0)
CL Item
Present in upper or lower (1)
CL Item
Present in both (2)
Item
Sensory (Pin prick to face, arm, trunk, and leg compare side to side)
integer
C2234461 (UMLS CUI [1])
Sensory
Code List
Sensory (Pin prick to face, arm, trunk, and leg compare side to side)
CL Item
Normal (0)
CL Item
Partial loss (1)
CL Item
Dense loss (2)
Item
Best language (Name items, describe a picture and read sentences)
integer
C2234462 (UMLS CUI [1])
Best language
Code List
Best language (Name items, describe a picture and read sentences)
CL Item
No aphasia (0)
CL Item
Mild-moderate aphasia (1)
CL Item
Severe aphasia (2)
CL Item
Mute (3)
Item
Dysarthria (Evaluate speech clarity by patient repeating listed words)
integer
C2234463 (UMLS CUI [1])
Dysarthria
Code List
Dysarthria (Evaluate speech clarity by patient repeating listed words)
CL Item
Normal articulation (0)
CL Item
Mild-moderate slurring (1)
CL Item
Severe, nearly intelligible or worse (2)
CL Item
Not scored (3)
Item
Extinction and Inattention (Use information from prior to testing to identify neglect or double stimuli testing)
integer
C2234464 (UMLS CUI [1])
Extinction and Inattention
Code List
Extinction and Inattention (Use information from prior to testing to identify neglect or double stimuli testing)
CL Item
No neglect (0)
CL Item
Partial neglect (1)
CL Item
Profound neglect (2)
Item Group
Modified Rankin Scale
C2984908 (UMLS CUI-1)
Item
For the qualifying ischemic stroke, please fill in the current Modified Rankin Scale below. (Indicate only one)
integer
C2984908 (UMLS CUI [1])
Modified Rankin Scale
Code List
For the qualifying ischemic stroke, please fill in the current Modified Rankin Scale below. (Indicate only one)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
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