ID

21013

Beschreibung

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

Stichworte

Versionen (2)
  1. 22.02.17 22.02.17 -
  2. 03.04.17 03.04.17 -
Hochgeladen am

3. April 2017

DOI

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

Englisch

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

1 Formulare  
Myocardial Infarction Report Form
Beschreibung

Myocardial Infarction Report Form

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

Date

Datentyp

date

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

Chest Pain

Datentyp

boolean

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

If Yes

Datentyp

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?
Beschreibung

Patient on study medication

Datentyp

boolean

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

if NO

Datentyp

integer

Alias
UMLS CUI [1]
C2348235
Assessments
Beschreibung

Assessments

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

ECG Changes

Datentyp

boolean

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

details of ECG

Datentyp

text

Alias
UMLS CUI [1]
C1522508
Q Waves
Beschreibung

Q waves

Datentyp

integer

Alias
UMLS CUI [1]
C1305738
ST elevation
Beschreibung

ST elevation

Datentyp

integer

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

ST depression >2mm

Datentyp

integer

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

T inversion >3mm

Datentyp

integer

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

bundle branch block

Datentyp

boolean

Alias
UMLS CUI [1]
C0006384
If Yes specify type
Beschreibung

If Yes

Datentyp

integer

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0085615
6. Rhythm:
Beschreibung

Rhythm

Datentyp

integer

Alias
UMLS CUI [1]
C0232187
7. Was coronary intervention done within the 3 days prior to the event?
Beschreibung

Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
8. Was myocardial infarction confirmed by enzymes or biomarkers?
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0443763
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0005516
Details for myocardial infarction
Beschreibung

Details for myocardial infarction

Alias
UMLS CUI-1
C0027051
UMLS CUI-2
C1522508
Value
Beschreibung

Value

Datentyp

text

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

Local Lab ranges Upper Limit Of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0523584
UMLS CUI [1,2]
C1519815
UMLS CUI [2,1]
C0920210
UMLS CUI [2,2]
C1519815
UMLS CUI [3,1]
C0523953
UMLS CUI [3,2]
C1519815
UMLS CUI [4,1]
C0201973
UMLS CUI [4,2]
C1519815
UMLS CUI [5,1]
C0202113
UMLS CUI [5,2]
C1519815
UMLS CUI [6,1]
C0201899
UMLS CUI [6,2]
C1519815
Hospitalization
Beschreibung

Hospitalization

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

Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
Fatal Outcome
Beschreibung

Fatal Outcome

Alias
UMLS CUI-1
C1705586
Was the event fatal (death within 28days). If yes please complete Death Report Form
Beschreibung

Fatal Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1705232
Please remember to fax Supporting Documentation clearly identified with the patient number
Beschreibung

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

Please indicate which supporting documentation has been supplied:
Beschreibung

Fax Supporting Documentation

Datentyp

integer

Alias
UMLS CUI [1]
C0678257
Invenstigator´s Declaration
Beschreibung

Invenstigator´s Declaration

Alias
UMLS CUI-1
C0008961
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.
Beschreibung

Invenstigator´s Declaration

Datentyp

text

Investigator´s signature
Beschreibung

Investigator´s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

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

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
If Yes
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])
if NO
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])
Q waves
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])
Q waves
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])
Q waves
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])
Q waves
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
C0006384 (UMLS CUI [1])
Item
If Yes specify type
integer
C0023211 (UMLS CUI [1])
C0085615 (UMLS CUI [2])
If Yes
Code List
If Yes specify type
CL Item
Right BBB (1)
CL Item
Left BBB (2)
Item
6. Rhythm:
integer
C0232187 (UMLS CUI [1])
Rhythm
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
C1532338 (UMLS CUI [1])
Myocardial Infarction
Item
8. Was myocardial infarction confirmed by enzymes or biomarkers?
boolean
C0443763 (UMLS CUI [1])
C0027051 (UMLS CUI [2,1])
C0005516 (UMLS CUI [2,2])
Item Group
Details for myocardial infarction
C0027051 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Item
Value
text
C1522609 (UMLS CUI [1])
Value
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
C0523584 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C0920210 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0523953 (UMLS CUI [3,1])
C1519815 (UMLS CUI [3,2])
C0201973 (UMLS CUI [4,1])
C1519815 (UMLS CUI [4,2])
C0202113 (UMLS CUI [5,1])
C1519815 (UMLS CUI [5,2])
C0201899 (UMLS CUI [6,1])
C1519815 (UMLS CUI [6,2])
Value
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
Did the vent lead to hospitalization. If yes please complete the Hospitalization Report Form.
boolean
C0019993 (UMLS CUI [1])
Item Group
Fatal Outcome
C1705586 (UMLS CUI-1)
Fatal Event
Item
Was the event fatal (death within 28days). If yes please complete Death Report Form
boolean
C1705232 (UMLS CUI [1])
Item Group
Please remember to fax Supporting Documentation clearly identified with the patient number
Item
Please indicate which supporting documentation has been supplied:
integer
C0678257 (UMLS CUI [1])
Fax Supporting Documentation
Code List
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
C0008961 (UMLS CUI-1)
Invenstigator´s Declaration
Item
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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