ID

37477

Beschreibung

Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01259622

Link

https://clinicaltrials.gov/show/NCT01259622

Stichworte

Versionen (1)
  1. 31.07.19 31.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01259622

Englisch

Eligibility Atrial Fibrillation NCT01259622

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
Beschreibung

ATRIAL FIBRILLATION SYMPTOMATIC Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0872146
atrial fibrillation documented by ecg at the start of study drug infusion.
Beschreibung

Atrial Fibrillation by ECG Finding

Datentyp

boolean

Alias
UMLS CUI [1]
C0344434
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous exposure to k201
Beschreibung

Exposure to K201

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4534673
qtcf (fridericia correction) >440 ms
Beschreibung

QTcF - Fridericia's Correction Formula

Datentyp

boolean

Alias
UMLS CUI [1]
C1882513
qrs interval > 140 ms
Beschreibung

QRS interval

Datentyp

boolean

Alias
UMLS CUI [1]
C0520880
paced atrial or paced ventricular rhythm on ecg
Beschreibung

Atrial-paced rhythm ECG | Ventricular-paced rhythm ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1168320
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C1168318
UMLS CUI [2,2]
C0013798
history of receiving another intravenous class i or class iii antiarrhythmic drug within 3 days of randomization
Beschreibung

Administration of intravenous antiarrhythmic drug Class

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4544567
UMLS CUI [1,2]
C0456387
history of amiodarone (oral or iv) in the last 3 months.
Beschreibung

Amiodarone Oral | Amiodarone Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002598
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0002598
UMLS CUI [2,2]
C1522726
clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
Beschreibung

Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
history of failed electrical cardioversion at any time in the past
Beschreibung

Electric Countershock failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0231175
history of polymorphic ventricular tachycardia (e.g. torsades des pointes)
Beschreibung

Polymorphic ventricular tachycardia | Torsades de Pointes

Datentyp

boolean

Alias
UMLS CUI [1]
C0344432
UMLS CUI [2]
C0040479
history or family history of long qt syndrome
Beschreibung

Long QT Syndrome | Family history of long QT syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C3839836
history of ventricular tachycardia requiring drug or device therapy
Beschreibung

Ventricular Tachycardia Requirement Pharmacotherapy | Ventricular Tachycardia Requirement Device therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C0042514
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1504335
ejection fraction of 40% or less.
Beschreibung

Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01259622

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ATRIAL FIBRILLATION SYMPTOMATIC Disease length
Item
symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
boolean
C0741283 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Atrial Fibrillation by ECG Finding
Item
atrial fibrillation documented by ecg at the start of study drug infusion.
boolean
C0344434 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exposure to K201
Item
previous exposure to k201
boolean
C0332157 (UMLS CUI [1,1])
C4534673 (UMLS CUI [1,2])
QTcF - Fridericia's Correction Formula
Item
qtcf (fridericia correction) >440 ms
boolean
C1882513 (UMLS CUI [1])
QRS interval
Item
qrs interval > 140 ms
boolean
C0520880 (UMLS CUI [1])
Atrial-paced rhythm ECG | Ventricular-paced rhythm ECG
Item
paced atrial or paced ventricular rhythm on ecg
boolean
C1168320 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1168318 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
Administration of intravenous antiarrhythmic drug Class
Item
history of receiving another intravenous class i or class iii antiarrhythmic drug within 3 days of randomization
boolean
C4544567 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
Amiodarone Oral | Amiodarone Intravenous
Item
history of amiodarone (oral or iv) in the last 3 months.
boolean
C0002598 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0002598 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable
Item
clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Electric Countershock failed
Item
history of failed electrical cardioversion at any time in the past
boolean
C0013778 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Polymorphic ventricular tachycardia | Torsades de Pointes
Item
history of polymorphic ventricular tachycardia (e.g. torsades des pointes)
boolean
C0344432 (UMLS CUI [1])
C0040479 (UMLS CUI [2])
Long QT Syndrome | Family history of long QT syndrome
Item
history or family history of long qt syndrome
boolean
C0023976 (UMLS CUI [1])
C3839836 (UMLS CUI [2])
Ventricular Tachycardia Requirement Pharmacotherapy | Ventricular Tachycardia Requirement Device therapy
Item
history of ventricular tachycardia requiring drug or device therapy
boolean
C0042514 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0042514 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1504335 (UMLS CUI [2,3])
Cardiac ejection fraction
Item
ejection fraction of 40% or less.
boolean
C0232174 (UMLS CUI [1])
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