ID

25817

Description

Explorative Study of AZD1305 in Atrial Fibrillation Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00643448

Link

https://clinicaltrials.gov/show/NCT00643448

Keywords

Versions (1)
  1. 9/20/17 9/20/17 -
Uploaded on

September 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00643448

English

Eligibility Atrial Fibrillation NCT00643448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented atrial fibrillation but in stable sr for at least 2 h and a maximum of 28 days.
Description

Atrial Fibrillation | Sinus rhythm Stable Duration

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0232201
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0449238
sinus rhythm at randomisation
Description

Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232201
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
haemodynamically unstable condition as judged by the investigator, systolic bp <100 mmhg or >180 mmhg, or diastolic bp >105 mmhg at randomisation
Description

Hemodynamic instability | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0948268
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
personal or family history of torsades de pointes (tdp), any other polymorphic ventricular tachycardia (pvt), sustained ventricular tachycardia, long qt syndrome and/or brugada syndrome
Description

Torsades de Pointes | Ventricular tachycardia, polymorphic | Sustained ventricular tachycardia | Long QT Syndrome | Brugada Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0040479
UMLS CUI [2]
C0344432
UMLS CUI [3]
C0750197
UMLS CUI [4]
C0023976
UMLS CUI [5]
C1142166
sinus bradycardia (<50 beats per minute (bpm)) at randomisation
Description

Sinus bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C0085610
qtc (fridericia, qtcf ) >450 ms measured in sinus rhythm at randomisation,
Description

QTcF | Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C1882513
UMLS CUI [2]
C0232201
serum potassium below 3.8 or above 5.0 mmol/l or plasma potassium below 3.6 or above 5.0 mmol/l
Description

Serum potassium measurement | Plasma potassium level

Data type

boolean

Alias
UMLS CUI [1]
C0302353
UMLS CUI [2]
C1272115
qrs duration >120 ms at randomisation
Description

QRS duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
use of any antiarrhythmic drug class i and/or iii, digitalis glycoside, qt prolonging drug and/or drug that inhibits cyp3a4, as well as st john's worth
Description

Anti-Arrhythmia Agents Class | Digitalis Glycosides | Pharmaceutical Preparations Causing Prolonged QT interval | CYP3A4 Inhibitors | ST. JOHN'S WORT EXTRACT

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C0012253
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0151878
UMLS CUI [4]
C3850053
UMLS CUI [5]
C0813171
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Similar models

Eligibility Atrial Fibrillation NCT00643448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Sinus rhythm Stable Duration
Item
documented atrial fibrillation but in stable sr for at least 2 h and a maximum of 28 days.
boolean
C0004238 (UMLS CUI [1])
C0232201 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Sinus rhythm
Item
sinus rhythm at randomisation
boolean
C0232201 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hemodynamic instability | Systolic Pressure | Diastolic blood pressure
Item
haemodynamically unstable condition as judged by the investigator, systolic bp <100 mmhg or >180 mmhg, or diastolic bp >105 mmhg at randomisation
boolean
C0948268 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Torsades de Pointes | Ventricular tachycardia, polymorphic | Sustained ventricular tachycardia | Long QT Syndrome | Brugada Syndrome
Item
personal or family history of torsades de pointes (tdp), any other polymorphic ventricular tachycardia (pvt), sustained ventricular tachycardia, long qt syndrome and/or brugada syndrome
boolean
C0040479 (UMLS CUI [1])
C0344432 (UMLS CUI [2])
C0750197 (UMLS CUI [3])
C0023976 (UMLS CUI [4])
C1142166 (UMLS CUI [5])
Sinus bradycardia
Item
sinus bradycardia (<50 beats per minute (bpm)) at randomisation
boolean
C0085610 (UMLS CUI [1])
QTcF | Sinus rhythm
Item
qtc (fridericia, qtcf ) >450 ms measured in sinus rhythm at randomisation,
boolean
C1882513 (UMLS CUI [1])
C0232201 (UMLS CUI [2])
Serum potassium measurement | Plasma potassium level
Item
serum potassium below 3.8 or above 5.0 mmol/l or plasma potassium below 3.6 or above 5.0 mmol/l
boolean
C0302353 (UMLS CUI [1])
C1272115 (UMLS CUI [2])
QRS duration
Item
qrs duration >120 ms at randomisation
boolean
C0429025 (UMLS CUI [1])
Anti-Arrhythmia Agents Class | Digitalis Glycosides | Pharmaceutical Preparations Causing Prolonged QT interval | CYP3A4 Inhibitors | ST. JOHN'S WORT EXTRACT
Item
use of any antiarrhythmic drug class i and/or iii, digitalis glycoside, qt prolonging drug and/or drug that inhibits cyp3a4, as well as st john's worth
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0012253 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0151878 (UMLS CUI [3,3])
C3850053 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
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