ID

20426

Descrição

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

Palavras-chave

  1. 22/02/2017 22/02/2017 -
  2. 03/04/2017 03/04/2017 -
Transferido a

22 de fevereiro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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

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

Myocardial Infarction Report Form
Descrição

Myocardial Infarction Report Form

Alias
UMLS CUI-1
C0027051
UMLS CUI-2
C1516308
1. Date of MI event (dd mon yy)
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027051
2. Chest pain?
Descrição

Chest Pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0008031
If `YES` please indicate whether typical or atypical chest pain
Descrição

If Yes

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C1521902
3. Was the patient on study medication within the 7 days prior to event?
Descrição

Patient on study medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
If no indicate which medication the patient was not taking (Please indicate all that apply)
Descrição

if NO

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348235
Assessments
Descrição

Assessments

Alias
UMLS CUI-1
C0220825
4. is infarction documented by ECG changes.
Descrição

ECG Changes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0855329
If Yes, please provide details of ECG
Descrição

details of ECG

Tipo de dados

text

Alias
UMLS CUI [1]
C1522508
Q Waves
Descrição

Q waves

Tipo de dados

integer

Alias
UMLS CUI [1]
C1305738
ST elevation
Descrição

ST elevation

Tipo de dados

integer

Alias
UMLS CUI [1]
C0520886
ST depression >2mm
Descrição

ST depression >2mm

Tipo de dados

integer

Alias
UMLS CUI [1]
C0520887
T inversion >3mm
Descrição

T inversion >3mm

Tipo de dados

integer

Alias
UMLS CUI [1]
C0520888
5. New bundle branch block (BBB)?
Descrição

bundle branch block

Tipo de dados

boolean

If Yes specify type
Descrição

If Yes

Tipo de dados

integer

6. Rhythm:
Descrição

Rhythm

Tipo de dados

integer

7. Was coronary intervention done within the 3 days prior to the event?
Descrição

Coronary Intervention

Tipo de dados

boolean

8. Was myocardial infarction confirmed by enzymes or biomarkers?
Descrição

Myocardial Infarction

Tipo de dados

boolean

Details for myocardial infarction
Descrição

Details for myocardial infarction

Value
Descrição

Value

Tipo de dados

text

Alias
UMLS CUI [1]
C1522609
Local Lab ranges Upper Limit Of Normal
Descrição

Local Lab ranges Upper Limit Of Normal

Tipo de dados

text

Hospitalization
Descrição

Hospitalization

Alias
UMLS CUI-1
C0019993
1. Did the vent lead to hospitalization. If yes please complete the Hospitalization Report Form.
Descrição

Hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019993
Fatal Outcome
Descrição

Fatal Outcome

2. Was the event fatal (death within 28days). If yes please complete Death Report Form
Descrição

Fatal Event

Tipo de dados

boolean

Please remember to fax Supporting Documentation clearly identified with the patient number
Descrição

Please remember to fax Supporting Documentation clearly identified with the patient number

3. Please indicate which supporting documentation has been supplied:
Descrição

Fax Supporting Documentation

Tipo de dados

integer

Invenstigator´s Declaration
Descrição

Invenstigator´s Declaration

3. 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.
Descrição

Invenstigator´s Declaration

Tipo de dados

text

Investigator´s signature
Descrição

Investigator´s signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Descrição

Date of Signature

Tipo de dados

date

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

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Myocardial Infarction Report Form
C0027051 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Date
Item
1. Date of MI event (dd mon yy)
date
C0011008 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Chest Pain
Item
2. Chest pain?
boolean
C0008031 (UMLS CUI [1])
Item
If `YES` please indicate whether typical or atypical chest pain
integer
C0027051 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Code List
If `YES` please indicate whether typical or atypical chest pain
CL Item
Typical (1)
CL Item
Atypical (2)
Patient on study medication
Item
3. Was the patient on study medication within the 7 days prior to event?
boolean
C0013227 (UMLS CUI [1])
Item
If no indicate which medication the patient was not taking (Please indicate all that apply)
integer
C2348235 (UMLS CUI [1])
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)
Item Group
Assessments
C0220825 (UMLS CUI-1)
ECG Changes
Item
4. is infarction documented by ECG changes.
boolean
C0855329 (UMLS CUI [1])
details of ECG
Item
If Yes, please provide details of ECG
text
C1522508 (UMLS CUI [1])
Item
Q Waves
integer
C1305738 (UMLS CUI [1])
Code List
Q Waves
CL Item
Anterior (1)
CL Item
Inferior (2)
CL Item
Lateral (3)
CL Item
Anterolateral (4)
CL Item
Posterior (5)
CL Item
None (6)
Item
ST elevation
integer
C0520886 (UMLS CUI [1])
Code List
ST elevation
CL Item
Anterior (1)
CL Item
Inferior (2)
CL Item
Lateral (3)
CL Item
Anterolateral (4)
CL Item
Posterior (5)
CL Item
None (6)
Item
ST depression >2mm
integer
C0520887 (UMLS CUI [1])
Code List
ST depression >2mm
CL Item
Anterior (1)
CL Item
Inferior (2)
CL Item
Lateral (3)
CL Item
Anterolateral (4)
CL Item
Posterior (5)
CL Item
None (6)
Item
T inversion >3mm
integer
C0520888 (UMLS CUI [1])
Code List
T inversion >3mm
CL Item
Anterior (1)
CL Item
Inferior (2)
CL Item
Lateral (3)
CL Item
Anterolateral (4)
CL Item
Posterior (5)
CL Item
None (6)
bundle branch block
Item
5. New bundle branch block (BBB)?
boolean
Item
If Yes specify type
integer
Code List
If Yes specify type
CL Item
Right BBB (1)
CL Item
Left BBB (2)
Item
6. Rhythm:
integer
Code List
6. Rhythm:
CL Item
Sinus (1)
CL Item
Atrial fib/flutter (2)
CL Item
Other (specify) (3)
Coronary Intervention
Item
7. Was coronary intervention done within the 3 days prior to the event?
boolean
Myocardial Infarction
Item
8. Was myocardial infarction confirmed by enzymes or biomarkers?
boolean
Item Group
Details for myocardial infarction
Item
Value
text
C1522609 (UMLS CUI [1])
Code List
Value
CL Item
Peak CK (9)
CL Item
Peak CK-MB (10)
CL Item
Peak LDH (11)
CL Item
Peak AST (12)
CL Item
Troponin T (13)
CL Item
Troponin I (14)
Item
Local Lab ranges Upper Limit Of Normal
text
Code List
Local Lab ranges Upper Limit Of Normal
CL Item
Peak CK (9)
CL Item
Peak CK-MB (10)
CL Item
Peak LDH (11)
CL Item
Peak AST (12)
CL Item
Troponin T (13)
CL Item
Troponin I (14)
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Hospitalization
Item
1. Did the vent lead to hospitalization. If yes please complete the Hospitalization Report Form.
boolean
C0019993 (UMLS CUI [1])
Item Group
Fatal Outcome
Fatal Event
Item
2. Was the event fatal (death within 28days). If yes please complete Death Report Form
boolean
Item Group
Please remember to fax Supporting Documentation clearly identified with the patient number
Item
3. Please indicate which supporting documentation has been supplied:
integer
Code List
3. Please indicate which supporting documentation has been supplied:
CL Item
ECGs (1)
CL Item
Hospital discharge summaries (2)
CL Item
Clinical description of event (3)
CL Item
Other (4)
Item Group
Invenstigator´s Declaration
Invenstigator´s Declaration
Item
3. 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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