ID

20228

Descrizione

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.

Keywords

versioni (2)
  1. 15/02/17 15/02/17 -
  2. 20/02/17 20/02/17 -
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15 febbraio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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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

Inglese

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 moduli  
Physical Examination
Descrizione

Physical Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0243095
1. Height
Descrizione

Body Height

Tipo di dati

float

Unità di misura
  • cm
Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0031809
cm
2. Weight
Descrizione

Body Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0031809
kg
3. Abdominal girth (Waist Circumference)
Descrizione

Abdominal girth

Tipo di dati

float

Unità di misura
  • cm
Alias
UMLS CUI [1,1]
C0232501
UMLS CUI [1,2]
C0031809
cm
4. Blood pressure systolic after 5 minutes sitting/supine
Descrizione

Systolic Blood Pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0031809
mmHg
4. Blood pressure diastolic after 5 minutes sitting/supine
Descrizione

Diastolic Blood Pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0031809
mmHg
5. Blood pressure position
Descrizione

Blood pressure position

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1828063
UMLS CUI [1,2]
C0031809
6. Heart rate
Descrizione

Heart rate

Tipo di dati

float

Unità di misura
  • beats/minute
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0031809
beats/minute
Pregnancy Test
Descrizione

Pregnancy Test

Alias
UMLS CUI-1
C0032976
7. Negative
Descrizione

Negative

Tipo di dati

integer

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

Positive

Tipo di dati

integer

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

Not applicable

Tipo di dati

integer

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

ECG

Alias
UMLS CUI-1
C1623258
10. Has an ECG been performed?
Descrizione

If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.

Tipo di dati

boolean

11. Are there any pathological Q waves?
Descrizione

Pathological Q waves

Tipo di dati

boolean

if Yes, in which leads (indicate all that apply)
Descrizione

if Yes, in which leads

Tipo di dati

integer

12. Does the ECG show left ventricular hypertrophy (LVH)?
Descrizione

ECG shows LVH

Tipo di dati

boolean

13. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
Descrizione

Modified Cornell Criteria

Tipo di dati

boolean

Neurological Assessment - NIH Stroke Scale
Descrizione

Neurological Assessment - NIH Stroke Scale

1a. Level of consciousness
Descrizione

Level of consciousness

Tipo di dati

integer

Alias
UMLS CUI [1]
C3482252
1b. LOC questions (Month, age)
Descrizione

LOC questions (Month, age)

Tipo di dati

integer

1c. LOC commands (Open, close eyes, make fist, let go)
Descrizione

LOC commands

Tipo di dati

integer

2. Best gaze (Eyes open patient follows examiner´s finger or face)
Descrizione

Best gaze

Tipo di dati

integer

3. Visual (Introduce visual stimulus/threat to patient´s visual field quadrants)
Descrizione

Visual

Tipo di dati

integer

4. Facial Palsy (Show teeth, raise eyebrows and squeeze eyes shut)
Descrizione

Facial Palsy

Tipo di dati

integer

5a. Motor Arm-Left (Elevate extremity 90° and score drift/movement)
Descrizione

Motor Arm-Left

Tipo di dati

integer

5b. Motor Arm-Right (Elevate extremity 90° and score drift/movement)
Descrizione

Motor Arm-Right

Tipo di dati

integer

6a. Motor Leg-Left (Elevate extremity 30° and score drift/movement)
Descrizione

Motor Leg-Left

Tipo di dati

integer

6b. Motor Leg-Right (Elevate extremity 30° and score drift/movement)
Descrizione

Motor Leg-Right

Tipo di dati

integer

7. Limb ataxia (Finger-nose, heel down shin)
Descrizione

Limb ataxia

Tipo di dati

integer

8. Sensory (Pin prick to face, arm, trunk, and leg compare side to side)
Descrizione

Sensory

Tipo di dati

integer

9. Best language (Name items, describe a picture and read sentences)
Descrizione

Best language

Tipo di dati

integer

10. Dysarthria (Evaluate speech clarity by patient repeating listed words)
Descrizione

Dysarthria

Tipo di dati

integer

11. Extinction and Inattention (Use information from prior to testing to identify neglect or double stimuli testing)
Descrizione

Extinction and Inattention

Tipo di dati

integer

Modified Rankin Scale
Descrizione

Modified Rankin Scale

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

Modified Rankin Scale

Tipo di dati

integer

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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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
C0243095 (UMLS CUI-2)
Body Height
Item
1. Height
float
C0005890 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Body Weight
Item
2. Weight
float
C0005910 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Abdominal girth
Item
3. Abdominal girth (Waist Circumference)
float
C0232501 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
4. Blood pressure systolic after 5 minutes sitting/supine
float
C0871470 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
4. Blood pressure diastolic after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Item
5. Blood pressure position
integer
C1828063 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Blood pressure position
Code List
5. Blood pressure position
CL Item
Sitting (1)
CL Item
Supine (2)
Heart rate
Item
6. Heart rate
float
C0018810 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
7. Negative
integer
C0205160 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Negative
Code List
7. Negative
CL Item
0 (1)
Item
8. Positive (patient is NOT eligible for trial)
integer
C1446409 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Positive
Code List
8. Positive (patient is NOT eligible for trial)
CL Item
1 (1)
Item
9. Not applicable (patient is male, or female who is post-menopausal or surgically sterilised)
integer
C1272460 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Not applicable
Code List
9. Not applicable (patient is male, or female who is post-menopausal or surgically sterilised)
CL Item
2 (1)
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG perfomance
Item
10. Has an ECG been performed?
boolean
Pathological Q waves
Item
11. Are there any pathological Q waves?
boolean
Item
if Yes, in which leads (indicate all that apply)
integer
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
12. Does the ECG show left ventricular hypertrophy (LVH)?
boolean
Modified Cornell Criteria
Item
13. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
boolean
Item Group
Neurological Assessment - NIH Stroke Scale
Item
1a. Level of consciousness
integer
C3482252 (UMLS CUI [1])
Level of consciousness
Code List
1a. 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
1b. LOC questions (Month, age)
integer
LOC questions (Month, age)
Code List
1b. LOC questions (Month, age)
CL Item
Both correct (0)
CL Item
One correct (1)
CL Item
Incorrect (2)
Item
1c. LOC commands (Open, close eyes, make fist, let go)
integer
LOC commands
Code List
1c. LOC commands (Open, close eyes, make fist, let go)
CL Item
Obeys (0)
CL Item
Obeys one correctly (1)
CL Item
Incorrect (2)
Item
2. Best gaze (Eyes open patient follows examiner´s finger or face)
integer
Best gaze
Code List
2. 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
3. Visual (Introduce visual stimulus/threat to patient´s visual field quadrants)
integer
Visual
Code List
3. 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
4. Facial Palsy (Show teeth, raise eyebrows and squeeze eyes shut)
integer
Facial Palsy
Code List
4. 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
5a. Motor Arm-Left (Elevate extremity 90° and score drift/movement)
integer
Motor Arm-Left
Code List
5a. 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
5b. Motor Arm-Right (Elevate extremity 90° and score drift/movement)
integer
Motor Arm-Left
Code List
5b. 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
6a. Motor Leg-Left (Elevate extremity 30° and score drift/movement)
integer
Motor Arm-Left
Code List
6a. 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
6b. Motor Leg-Right (Elevate extremity 30° and score drift/movement)
integer
Motor Arm-Left
Code List
6b. 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
7. Limb ataxia (Finger-nose, heel down shin)
integer
Limb ataxia
Code List
7. 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
8. Sensory (Pin prick to face, arm, trunk, and leg compare side to side)
integer
Sensory
Code List
8. 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
9. Best language (Name items, describe a picture and read sentences)
integer
Best language
Code List
9. 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
10. Dysarthria (Evaluate speech clarity by patient repeating listed words)
integer
Dysarthria
Code List
10. 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
11. Extinction and Inattention (Use information from prior to testing to identify neglect or double stimuli testing)
integer
Extinction and Inattention
Code List
11. 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
12. For the qualifying ischemic stroke, please fill in the current Modified Rankin Scale below. (Indicate only one)
integer
Modified Rankin Scale
Code List
12. 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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