ID

25842

Description

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00668759

Lien

https://clinicaltrials.gov/show/NCT00668759

Mots-clés

Versions (1)
  1. 20/09/2017 20/09/2017 -
Téléchargé le

20 septembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00668759

Anglais

Eligibility Atrial Fibrillation NCT00668759

1 Formulaires  
Criteria
Description

Criteria

have symptomatic af of 3 to 48 hours duration at baseline.
Description

SYMPTOMATIC ATRIAL FIBRILLATION Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0449238
be eligible for cardioversion.
Description

Patient eligible Cardioversion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0013778
have adequate anticoagulation therapy for cardioversion in accordance with standard of practice as recommended by acc/aha/esc guidelines [1].
Description

Anticoagulation Therapy Cardioversion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0013778
be hemodynamically stable and have systolic blood pressure (bp) above 100 mmhg and less than 160 mmhg and diastolic bp less than 95 mmhg at screening and baseline.
Description

Hemodynamics Stable | Systolic Pressure | Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019010
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
key exclusion criteria:
Description

Exclusion Criteria Main

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
known or suspected prolonged qt or uncorrected qt interval of >440 msec as measured at screening on a 12 lead ecg, familial long qt syndrome, or previous torsades de pointes, ventricular fibrillation; or sustained ventricular tachycardia (vt).
Description

Prolonged QT interval | Prolonged QT interval Suspected | QT interval duration uncorrected 12 lead ECG | Long QT Syndrome Familial | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia

Type de données

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2,1]
C0151878
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0577807
UMLS CUI [3,2]
C4072785
UMLS CUI [3,3]
C0430456
UMLS CUI [4,1]
C0023976
UMLS CUI [4,2]
C0241888
UMLS CUI [5]
C0040479
UMLS CUI [6]
C0042510
UMLS CUI [7]
C0750197
symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats per minute (bpm) as documented by 12-lead ecg at screening.
Description

BRADYCARDIA SYMPTOMATIC | Sick Sinus Syndrome | Ventricular rate 12 lead ECG

Type de données

boolean

Alias
UMLS CUI [1]
C0741627
UMLS CUI [2]
C0037052
UMLS CUI [3,1]
C2189285
UMLS CUI [3,2]
C0430456
a qrs interval >140 msec.
Description

QRS interval

Type de données

boolean

Alias
UMLS CUI [1]
C0520880
atrial flutter.
Description

Atrial Flutter

Type de données

boolean

Alias
UMLS CUI [1]
C0004239
significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.
Description

Valvular Stenosis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive

Type de données

boolean

Alias
UMLS CUI [1]
C1883524
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0031048
documented previous episodes of second or third degree atrioventricular (av) block.
Description

Second degree atrioventricular block Episode of | Complete atrioventricular block Episode of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C0332189
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0332189
had a myocardial infarction (mi), acute coronary syndrome or cardiac surgery within 30 days prior to entry into the study.
Description

Myocardial Infarction | Acute Coronary Syndrome | Cardiac Surgery procedures

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0018821
uncorrected electrolyte imbalance of serum potassium or magnesium. both k+ and mg2+
Description

Electrolyte imbalance uncorrected | Serum potassium measurement K+ | Serum magnesium measurement Mg2+

Type de données

boolean

Alias
UMLS CUI [1,1]
C0342579
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C0302353
UMLS CUI [2,2]
C0597277
UMLS CUI [3,1]
C0202125
UMLS CUI [3,2]
C2346927
must be corrected prior to dosing.
Description

Requirement Correction Before Dosage

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1947976
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0178602
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Similar models

Eligibility Atrial Fibrillation NCT00668759

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
SYMPTOMATIC ATRIAL FIBRILLATION Duration
Item
have symptomatic af of 3 to 48 hours duration at baseline.
boolean
C0741283 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Patient eligible Cardioversion
Item
be eligible for cardioversion.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0013778 (UMLS CUI [1,3])
Anticoagulation Therapy Cardioversion
Item
have adequate anticoagulation therapy for cardioversion in accordance with standard of practice as recommended by acc/aha/esc guidelines [1].
boolean
C0003281 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
Hemodynamics Stable | Systolic Pressure | Diastolic blood pressure
Item
be hemodynamically stable and have systolic blood pressure (bp) above 100 mmhg and less than 160 mmhg and diastolic bp less than 95 mmhg at screening and baseline.
boolean
C0019010 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Prolonged QT interval | Prolonged QT interval Suspected | QT interval duration uncorrected 12 lead ECG | Long QT Syndrome Familial | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia
Item
known or suspected prolonged qt or uncorrected qt interval of >440 msec as measured at screening on a 12 lead ecg, familial long qt syndrome, or previous torsades de pointes, ventricular fibrillation; or sustained ventricular tachycardia (vt).
boolean
C0151878 (UMLS CUI [1])
C0151878 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0577807 (UMLS CUI [3,1])
C4072785 (UMLS CUI [3,2])
C0430456 (UMLS CUI [3,3])
C0023976 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0040479 (UMLS CUI [5])
C0042510 (UMLS CUI [6])
C0750197 (UMLS CUI [7])
BRADYCARDIA SYMPTOMATIC | Sick Sinus Syndrome | Ventricular rate 12 lead ECG
Item
symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats per minute (bpm) as documented by 12-lead ecg at screening.
boolean
C0741627 (UMLS CUI [1])
C0037052 (UMLS CUI [2])
C2189285 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
QRS interval
Item
a qrs interval >140 msec.
boolean
C0520880 (UMLS CUI [1])
Atrial Flutter
Item
atrial flutter.
boolean
C0004239 (UMLS CUI [1])
Valvular Stenosis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive
Item
significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.
boolean
C1883524 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0031048 (UMLS CUI [4])
Second degree atrioventricular block Episode of | Complete atrioventricular block Episode of
Item
documented previous episodes of second or third degree atrioventricular (av) block.
boolean
C0264906 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
Myocardial Infarction | Acute Coronary Syndrome | Cardiac Surgery procedures
Item
had a myocardial infarction (mi), acute coronary syndrome or cardiac surgery within 30 days prior to entry into the study.
boolean
C0027051 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
Electrolyte imbalance uncorrected | Serum potassium measurement K+ | Serum magnesium measurement Mg2+
Item
uncorrected electrolyte imbalance of serum potassium or magnesium. both k+ and mg2+
boolean
C0342579 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0302353 (UMLS CUI [2,1])
C0597277 (UMLS CUI [2,2])
C0202125 (UMLS CUI [3,1])
C2346927 (UMLS CUI [3,2])
Requirement Correction Before Dosage
Item
must be corrected prior to dosing.
boolean
C1514873 (UMLS CUI [1,1])
C1947976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
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