ID

20429

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

  1. 22.02.17 22.02.17 -
Hochgeladen am

22. Februar 2017

DOI

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New Or Worsening Congestive Heart Failure (CHF) Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

New Or Worsening Congestive Heart Failure (CHF) Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

New Or Worsening Congestive Heart Failure (CHF) Report FormForm
Beschreibung

New Or Worsening Congestive Heart Failure (CHF) Report FormForm

1. Date of onset of CHF (dd mon yy)
Beschreibung

Date of onset of CHF

Datentyp

date

2. Was the patient on study medication within the 7 days prior to the event?
Beschreibung

Study Medication

Datentyp

boolean

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

if NO

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
3. Did the patient experience characteristic symptoms or signs of CHF?
Beschreibung

Characteristic Symptoms

Datentyp

boolean

If Yes, indicate which
Beschreibung

If Yes

Datentyp

integer

4. Was evidence of pulmonary congestion confirmed by X-ray?
Beschreibung

pulmonary congestion

Datentyp

boolean

Alias
UMLS CUI [1]
C0242073
5. Was ejection fraction <40% or other evidence of systolic dysfunction?
Beschreibung

ejection fraction

Datentyp

boolean

If ejection fraction <40% please provide ejection fraction
Beschreibung

If yes

Datentyp

float

Maßeinheiten
  • %
%
6. Was there evidence of diastolic dysfunction?
Beschreibung

diastolic dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0520863
If evidence of diastolic or systolic dysfunction please indicate which method was used
Beschreibung

Evidence of diastolic dysfunction

Datentyp

integer

7. Please indicate which of the following events accompanied the CHF: (Indicate all that apply)
Beschreibung

CHF accompanied events

Datentyp

integer

8. Please indicate which of the following treatments were given for the CHF: (Indicate all that apply)
Beschreibung

Treatment given for CHF

Datentyp

integer

Hospitalization
Beschreibung

Hospitalization

Alias
UMLS CUI-1
C0019993
9. Did the event lead to hospitalization? If Yes please complete the Hospitalization Report Form.
Beschreibung

Events Leading to Hospitalization

Datentyp

boolean

If No, please indicate where patient attended:
Beschreibung

if NO

Datentyp

integer

Specify "Other":
Beschreibung

Specification

Datentyp

text

Alias
UMLS CUI [1]
C2348235
Fatal Outcome
Beschreibung

Fatal Outcome

10. Was the event fatal (death within 28 days). If Yes please complete Death Report Form.
Beschreibung

Fatal Event

Datentyp

boolean

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

Invenstigator´s Declaration
Beschreibung

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.
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

Ähnliche Modelle

New Or Worsening Congestive Heart Failure (CHF) Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
New Or Worsening Congestive Heart Failure (CHF) Report FormForm
Date of onset of CHF
Item
1. Date of onset of CHF (dd mon yy)
date
Study Medication
Item
2. Was the patient on study medication within the 7 days prior to the event?
boolean
Item
If NO, which medication was 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, which medication was 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)
Characteristic Symptoms
Item
3. Did the patient experience characteristic symptoms or signs of CHF?
boolean
Item
If Yes, indicate which
integer
Code List
If Yes, indicate which
CL Item
Orthopnea (1)
CL Item
Peripheral edema (2)
CL Item
Elevation of JVP (3)
CL Item
Shortness of breath at rest (4)
CL Item
Shortness of breath during exertion (5)
CL Item
Paraoxysmal nocturnal dyspnea (6)
CL Item
Rales (7)
pulmonary congestion
Item
4. Was evidence of pulmonary congestion confirmed by X-ray?
boolean
C0242073 (UMLS CUI [1])
ejection fraction
Item
5. Was ejection fraction <40% or other evidence of systolic dysfunction?
boolean
If yes
Item
If ejection fraction <40% please provide ejection fraction
float
diastolic dysfunction
Item
6. Was there evidence of diastolic dysfunction?
boolean
C0520863 (UMLS CUI [1])
Item
If evidence of diastolic or systolic dysfunction please indicate which method was used
integer
Code List
If evidence of diastolic or systolic dysfunction please indicate which method was used
CL Item
Radionuclide angiography (1)
CL Item
Echo (2)
CL Item
LV angio (3)
Item
7. Please indicate which of the following events accompanied the CHF: (Indicate all that apply)
integer
Code List
7. Please indicate which of the following events accompanied the CHF: (Indicate all that apply)
CL Item
Anemia (1)
CL Item
Other infections (2)
CL Item
Atrial fibrillation (3)
CL Item
Pneumonia/Respiratory Infection (4)
CL Item
Acute Ischemic event (5)
CL Item
Other Precipitating Cause (6)
Item
8. Please indicate which of the following treatments were given for the CHF: (Indicate all that apply)
integer
Code List
8. Please indicate which of the following treatments were given for the CHF: (Indicate all that apply)
CL Item
Oral diuretics (1)
CL Item
Digoxin (2)
CL Item
IV Inotropes (3)
CL Item
IV diuretics (4)
CL Item
Open Label ACE inhibitors (5)
CL Item
Open Label ARBs (6)
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Events Leading to Hospitalization
Item
9. Did the event lead to hospitalization? If Yes please complete the Hospitalization Report Form.
boolean
Item
If No, please indicate where patient attended:
integer
Code List
If No, please indicate where patient attended:
CL Item
Emergency Room (1)
CL Item
Physician Office (2)
CL Item
Other (3)
Specification
Item
Specify "Other":
text
C2348235 (UMLS CUI [1])
Item Group
Fatal Outcome
Fatal Event
Item
10. 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 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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