ID

37516

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01447862

Nyckelord

Versioner (1)
  1. 2019-08-04 2019-08-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 augusti 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01447862

Engelsk

Eligibility Atrial Fibrillation NCT01447862

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Symptoms Atrial Fibrillation Duration

Datatyp

boolean

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

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)
Beskrivning

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

Datatyp

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%
Beskrivning

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

Datatyp

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
Beskrivning

Signs Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable

Datatyp

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
Beskrivning

Ventricular Heart Rate resting | Artificial cardiac pacemaker Absent

Datatyp

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
Beskrivning

Prolonged QT interval

Datatyp

boolean

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

Wolff-Parkinson-White Syndrome

Datatyp

boolean

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

Torsades de Pointes Cardiac Arrhythmia | Ventricular tachycardia, polymorphic

Datatyp

boolean

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

Signs Thyrotoxicosis

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

Electrolyte abnormality serum | Therapy Adequate | Potassium measurement

Datatyp

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
Beskrivning

Anti-Arrhythmia Agents Intravenous Class

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Atrial Fibrillation NCT01447862

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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