ID

37516

Descrição

Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01447862

Link

https://clinicaltrials.gov/show/NCT01447862

Palavras-chave

Versões (1)
  1. 04/08/2019 04/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01447862

Inglês

Eligibility Atrial Fibrillation NCT01447862

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptoms of atrial fibrillation since no longer than 48 hours
Descrição

Symptoms Atrial Fibrillation Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0449238
age 18 - 90 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure < 100 mmhg, dyspnea, loss of consciousness, unstable angina)
Descrição

Patient need for Electric Countershock Immediate | Etiology Hemodynamic instability | Hypotension | Systolic Pressure | Dyspnea | Unconscious State | Angina, Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0013778
UMLS CUI [1,3]
C0205253
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0948268
UMLS CUI [3]
C0020649
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0013404
UMLS CUI [6]
C0041657
UMLS CUI [7]
C0002965
moderate to severe heart failure (nyha iii/iv) and patients with previously documented left ventricular ejection fraction (lvef) ≤ 35%
Descrição

Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1275491
UMLS CUI [3]
C0428772
history or signs of acute coronary syndromes (acute myocardial infarction, unstable angina) within the last 30 days
Descrição

Signs Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
resting ventricular rate < 80 beats per minute without pace maker back-up
Descrição

Ventricular Heart Rate resting | Artificial cardiac pacemaker Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1883530
UMLS CUI [1,2]
C0035253
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C0332197
qt interval of > 440 milliseconds
Descrição

Prolonged QT interval

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151878
wolff-parkinson-white (wpw) syndrome
Descrição

Wolff-Parkinson-White Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043202
history of torsade de pointes arrhythmias or other polymorphic ventricular tachycardias
Descrição

Torsades de Pointes Cardiac Arrhythmia | Ventricular tachycardia, polymorphic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040479
UMLS CUI [1,2]
C0003811
UMLS CUI [2]
C0344432
signs of thyreotoxicosis
Descrição

Signs Thyrotoxicosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0040156
sick sinus syndrome or atrioventricular block greater than first degree
Descrição

Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037052
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
severe valvular heart disease, clinically meaningful hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
Descrição

Heart valve disease Severe | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0031048
serious disorders of the hepatic, renal (creatinine > 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders
Descrição

Liver disease Serious | Kidney Disease Serious | Creatinine measurement, serum | Lung disease Serious | Gastrointestinal Disease Serious | Hematological Disease Serious | CNS disorder Serious | Mental disorders Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0201976
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0205404
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0018939
UMLS CUI [6,2]
C0205404
UMLS CUI [7,1]
C0007682
UMLS CUI [7,2]
C0205404
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0205404
abnormal serum electrolytes despite adequate therapy (especially potassium <3.5 mmol/l or > 5.5 mmol/l)
Descrição

Electrolyte abnormality serum | Therapy Adequate | Potassium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0541924
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
UMLS CUI [3]
C0202194
intravenous use of other class i or iii antiarrythmic drugs within 4 hours of study drug application
Descrição

Anti-Arrhythmia Agents Intravenous Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0456387
pregnancy (a β-hcg test will be performed in all female subjects apart from women > 50 years and with amenorrhea for at least 12 month (absence of other causes of amenorrhoea)
Descrição

Pregnancy | Gender Serum pregnancy test (B-HCG) | Exception Age | Exception Amenorrhea Duration | Absence Cause Other Amenorrhea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430060
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001779
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0002453
UMLS CUI [4,3]
C0449238
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0015127
UMLS CUI [5,3]
C0205394
UMLS CUI [5,4]
C0002453
known hypersensitivity to study medication
Descrição

Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Eligibility Atrial Fibrillation NCT01447862

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Symptoms Atrial Fibrillation Duration
Item
symptoms of atrial fibrillation since no longer than 48 hours
boolean
C1457887 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Age
Item
age 18 - 90 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient need for Electric Countershock Immediate | Etiology Hemodynamic instability | Hypotension | Systolic Pressure | Dyspnea | Unconscious State | Angina, Unstable
Item
need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure < 100 mmhg, dyspnea, loss of consciousness, unstable angina)
boolean
C0686904 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0948268 (UMLS CUI [2,2])
C0020649 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C0013404 (UMLS CUI [5])
C0041657 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction
Item
moderate to severe heart failure (nyha iii/iv) and patients with previously documented left ventricular ejection fraction (lvef) ≤ 35%
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0428772 (UMLS CUI [3])
Signs Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable
Item
history or signs of acute coronary syndromes (acute myocardial infarction, unstable angina) within the last 30 days
boolean
C0311392 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Ventricular Heart Rate resting | Artificial cardiac pacemaker Absent
Item
resting ventricular rate < 80 beats per minute without pace maker back-up
boolean
C1883530 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Prolonged QT interval
Item
qt interval of > 440 milliseconds
boolean
C0151878 (UMLS CUI [1])
Wolff-Parkinson-White Syndrome
Item
wolff-parkinson-white (wpw) syndrome
boolean
C0043202 (UMLS CUI [1])
Torsades de Pointes Cardiac Arrhythmia | Ventricular tachycardia, polymorphic
Item
history of torsade de pointes arrhythmias or other polymorphic ventricular tachycardias
boolean
C0040479 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2])
Signs Thyrotoxicosis
Item
signs of thyreotoxicosis
boolean
C0311392 (UMLS CUI [1,1])
C0040156 (UMLS CUI [1,2])
Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block
Item
sick sinus syndrome or atrioventricular block greater than first degree
boolean
C0037052 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Heart valve disease Severe | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive
Item
severe valvular heart disease, clinically meaningful hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0031048 (UMLS CUI [4])
Liver disease Serious | Kidney Disease Serious | Creatinine measurement, serum | Lung disease Serious | Gastrointestinal Disease Serious | Hematological Disease Serious | CNS disorder Serious | Mental disorders Serious
Item
serious disorders of the hepatic, renal (creatinine > 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders
boolean
C0023895 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0024115 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0017178 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0018939 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0007682 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0004936 (UMLS CUI [8,1])
C0205404 (UMLS CUI [8,2])
Electrolyte abnormality serum | Therapy Adequate | Potassium measurement
Item
abnormal serum electrolytes despite adequate therapy (especially potassium <3.5 mmol/l or > 5.5 mmol/l)
boolean
C0541924 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0202194 (UMLS CUI [3])
Anti-Arrhythmia Agents Intravenous Class
Item
intravenous use of other class i or iii antiarrythmic drugs within 4 hours of study drug application
boolean
C0003195 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Pregnancy | Gender Serum pregnancy test (B-HCG) | Exception Age | Exception Amenorrhea Duration | Absence Cause Other Amenorrhea
Item
pregnancy (a β-hcg test will be performed in all female subjects apart from women > 50 years and with amenorrhea for at least 12 month (absence of other causes of amenorrhoea)
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0002453 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0015127 (UMLS CUI [5,2])
C0205394 (UMLS CUI [5,3])
C0002453 (UMLS CUI [5,4])
Hypersensitivity Investigational New Drugs
Item
known hypersensitivity to study medication
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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