ID

20430

Descripción

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

Link

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

Palabras clave

  1. 22/2/17 22/2/17 -
  2. 3/4/17 3/4/17 -
Subido en

22 de febrero de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0

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Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Stroke Report Form
Descripción

Stroke Report Form

1. Was the patient on study medication within the 7 days prior to the event?
Descripción

Study Medication Prior To Event

Tipo de datos

boolean

If NO, indicate which medication the patient was not taking (please indicate all that apply):
Descripción

if NO

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
2. Date of onset stroke symptoms (dd mon yy)
Descripción

Date of onset stroke symptoms

Tipo de datos

date

3. Time of onset stroke symptoms (24 hour clock time-hh:mm)
Descripción

Time of onset stroke symptoms

Tipo de datos

time

4. Duration of symptoms:
Descripción

Duration

Tipo de datos

integer

Alias
UMLS CUI [1]
C0449238
5. Decreased consciousness
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

6. Headache
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018681
7. Nausea-Vomiting
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027498
8. Dysphasia
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0973461
9. Neglect
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0422887
10. Dysarthria
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013362
11. Hemaniopia
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018979
12. Ataxia
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0004134
13. Diplopia
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0012569
14. Monocular vision loss
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

15. Vertigo
Descripción

Please indicate symptoms at time of stroke:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042571
16. Motor Power Face
Descripción

Motor Power Face

Tipo de datos

integer

17. Motor power arm
Descripción

Motor power arm

Tipo de datos

integer

18. Motor power leg
Descripción

Motor power leg

Tipo de datos

integer

19. Sensation Face
Descripción

Sensation Face

Tipo de datos

integer

20. Sensation arm
Descripción

Sensation arm

Tipo de datos

integer

21. Sensation leg
Descripción

Sensation leg

Tipo de datos

integer

22. Location of new stroke
Descripción

Location of new stroke

Tipo de datos

integer

23. Please indicate which of the following were done in conjunction with the stroke:
Descripción

Done in conjunction with stroke

Tipo de datos

integer

Specify other:
Descripción

Specification

Tipo de datos

text

Alias
UMLS CUI [1]
C2348235
new stroke confirmed by brain imaging
Descripción

new stroke confirmed by brain imaging

Tipo de datos

boolean

Stroke Type
Descripción

Stroke Type

Alias
UMLS CUI-1
C3897486
1. Please indicate stroke type
Descripción

Stroke Type

Tipo de datos

integer

Alias
UMLS CUI [1]
C3897486
Was new stroke confined to a central retinal arterial occlusion?
Descripción

Ischemic infarction

Tipo de datos

boolean

Toast Criteria
Descripción

Toast Criteria

2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
Descripción

Etiologic subtype

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0015127
Modified Rankin Scale
Descripción

Modified Rankin Scale

Alias
UMLS CUI-1
C2984908
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
Descripción

Modified Rankin Scale

Tipo de datos

integer

Alias
UMLS CUI [1]
C2984908
Fatal Outcome
Descripción

Fatal Outcome

5. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
Descripción

Fatal Event

Tipo de datos

boolean

Please remember to fax supporting documentation clearly identified with the patient number
Descripción

Please remember to fax supporting documentation clearly identified with the patient number

6. Please indicate which supporting documentation has been supplied:
Descripción

supporting documentation

Tipo de datos

integer

Invenstigator´s Declaration
Descripción

Invenstigator´s Declaration

8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
Descripción

Invenstigator´s Declaration

Tipo de datos

text

Investigator´s signature
Descripción

Investigator´s signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Descripción

Date of Signature

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316

Similar models

Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Stroke Report Form
Study Medication Prior To Event
Item
1. Was the patient on study medication within the 7 days prior to the event?
boolean
Item
If NO, indicate which medication the patient was not taking (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
Code List
If NO, indicate which medication the patient was not taking (please indicate all that apply):
CL Item
Bottle A (1)
CL Item
Bottle B (2)
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Date of onset stroke symptoms
Item
2. Date of onset stroke symptoms (dd mon yy)
date
Time of onset stroke symptoms
Item
3. Time of onset stroke symptoms (24 hour clock time-hh:mm)
time
Item
4. Duration of symptoms:
integer
C0449238 (UMLS CUI [1])
Code List
4. Duration of symptoms:
CL Item
0-1 hour (1)
CL Item
1-24 hours (2)
CL Item
<24 hours (3)
Item
5. Decreased consciousness
integer
Code List
5. Decreased consciousness
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
6. Headache
integer
C0018681 (UMLS CUI [1])
Code List
6. Headache
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
7. Nausea-Vomiting
integer
C0027498 (UMLS CUI [1])
Code List
7. Nausea-Vomiting
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
8. Dysphasia
integer
C0973461 (UMLS CUI [1])
Code List
8. Dysphasia
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
9. Neglect
integer
C0422887 (UMLS CUI [1])
Code List
9. Neglect
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
10. Dysarthria
integer
C0013362 (UMLS CUI [1])
Code List
10. Dysarthria
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
11. Hemaniopia
integer
C0018979 (UMLS CUI [1])
Code List
11. Hemaniopia
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
12. Ataxia
integer
C0004134 (UMLS CUI [1])
Code List
12. Ataxia
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
13. Diplopia
integer
C0012569 (UMLS CUI [1])
Code List
13. Diplopia
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
14. Monocular vision loss
integer
Code List
14. Monocular vision loss
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
15. Vertigo
integer
C0042571 (UMLS CUI [1])
Code List
15. Vertigo
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
Item
16. Motor Power Face
integer
Code List
16. Motor Power Face
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
17. Motor power arm
integer
Code List
17. Motor power arm
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
18. Motor power leg
integer
Code List
18. Motor power leg
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
19. Sensation Face
integer
Code List
19. Sensation Face
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
20. Sensation arm
integer
Code List
20. Sensation arm
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
21. Sensation leg
integer
Code List
21. Sensation leg
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
Item
22. Location of new stroke
integer
Code List
22. Location of new stroke
CL Item
left hemispheric (1)
CL Item
right hemispheric (2)
CL Item
brainstem (3)
CL Item
bilateral (4)
CL Item
uncertain (5)
Item
23. Please indicate which of the following were done in conjunction with the stroke:
integer
Code List
23. Please indicate which of the following were done in conjunction with the stroke:
CL Item
Magnetic resonance imaging (1)
CL Item
Computerized Tomography (2)
CL Item
Diffusion weighted imaging (3)
CL Item
Perfusion imaging (4)
CL Item
Angiography (5)
CL Item
Doppler/Duplex (6)
CL Item
Treated with Thrombolytics (7)
CL Item
Treated with surgery (8)
CL Item
Other (9)
Specification
Item
Specify other:
text
C2348235 (UMLS CUI [1])
new stroke confirmed by brain imaging
Item
boolean
Item Group
Stroke Type
C3897486 (UMLS CUI-1)
Item
1. Please indicate stroke type
integer
C3897486 (UMLS CUI [1])
Code List
1. Please indicate stroke type
CL Item
Ischemic (infarction) (1)
CL Item
Subarachnoid hemorrhage (2)
CL Item
Intracerebral hemorrhage (3)
CL Item
Uncertain type (4)
Ischemic infarction
Item
Was new stroke confined to a central retinal arterial occlusion?
boolean
Item Group
Toast Criteria
Item
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
integer
C0038454 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Code List
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
CL Item
Large-artery atherosclerosis (1)
CL Item
Cardioembolism (2)
CL Item
Small-artery occlusion (lacune) (3)
CL Item
Acute stroke of other determined etiology (4)
CL Item
Stroke of underdetermined etiology (5)
Item Group
Modified Rankin Scale
C2984908 (UMLS CUI-1)
Item
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
integer
C2984908 (UMLS CUI [1])
Code List
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
CL Item
Grad 0 (1)
CL Item
Grade 1 (2)
CL Item
Grade 2 (3)
CL Item
Grade 3 (4)
CL Item
Grade 4 (5)
CL Item
Grade 5 (6)
CL Item
Grade 6 (fatal) (7)
Item Group
Fatal Outcome
Fatal Event
Item
5. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
boolean
Item Group
Please remember to fax supporting documentation clearly identified with the patient number
Item
6. Please indicate which supporting documentation has been supplied:
integer
Code List
6. Please indicate which supporting documentation has been supplied:
CL Item
Brain Imaging (1)
CL Item
Vascular Imaging (2)
CL Item
Cardiac Evaluation (3)
CL Item
Other supporting testing (4)
Item Group
Invenstigator´s Declaration
Invenstigator´s Declaration
Item
8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])

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