ID

37461

Beschreibung

A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045); ODM derived from: https://clinicaltrials.gov/show/NCT00989001

Link

https://clinicaltrials.gov/show/NCT00989001

Stichworte

Versionen (1)
  1. 30.07.19 30.07.19 -
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See clinicaltrials.gov

Hochgeladen am

30. Juli 2019

DOI

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Eligibility Atrial Fibrillation NCT00989001

Englisch

Eligibility Atrial Fibrillation NCT00989001

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
females must be not pregnant or nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30 days post study treatment
Beschreibung

Pregnancy Absent | Breast Feeding Absent | Premenopausal state Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
subject must have recent onset (> 3 hours to <= 7 days) symptomatic af to be best managed by acute conversion to sr
Beschreibung

ATRIAL FIBRILLATION SYMPTOMATIC Onset Recent | Conversion Sinus rhythm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0439836
UMLS CUI [2,2]
C0232201
subject must have adequate anticoagulant therapy
Beschreibung

Anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
subject must have systolic blood pressure (sbp) above 90 mmhg and less than 160 mmhg and diastolic blood pressure (dbp) less than 95 mmhg at screening and baseline
Beschreibung

Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
subject must have a body weight between 45 and 136 kg, inclusive (99 and 300 lbs)
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of heart failure or documentation of left ventricular dysfunction
Beschreibung

Heart failure | Ventricular Dysfunction, Left

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0242698
subject has known or suspected prolonged qt or uncorrected qt interval of > 0.440 sec
Beschreibung

Prolonged QT interval | Prolonged QT interval Suspected | QT interval uncorrected

Datentyp

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2,1]
C0151878
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0429028
UMLS CUI [3,2]
C4072785
subject has symptomatic bradycardia or ventricular rate less than 50 bpm at screening, unless controlled by a pacemaker
Beschreibung

BRADYCARDIA SYMPTOMATIC | Ventricular Heart Rate | Exception Controlled by Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0741627
UMLS CUI [2]
C1883530
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0332298
UMLS CUI [3,3]
C0030163
subject has bradycardia (heart rate less than 50 bpm) or hypotension (sbp less that 90 mmhg) after receiving a loading, bolus dose, or sustained infusion of any rate control medication during screening
Beschreibung

Bradycardia | Hypotension | Systolic Pressure | Status post Receive Loading dose | Status post Receive Bolus Dosing Unit | Infusion Rate Control Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0020649
UMLS CUI [3]
C0871470
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C3714444
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1514756
UMLS CUI [5,3]
C1705509
UMLS CUI [6,1]
C0574032
UMLS CUI [6,2]
C1521828
UMLS CUI [6,3]
C2587213
UMLS CUI [6,4]
C0013227
subject has a qrs interval > 0.14 sec., unless subject has a pacemaker
Beschreibung

QRS interval | Exception Artificial cardiac pacemaker Present

Datentyp

boolean

Alias
UMLS CUI [1]
C0520880
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030163
UMLS CUI [2,3]
C0150312
subject had a myocardial infarction (mi), acute coronary syndrome, cardiac surgery (including percutaneous transluminal coronary angioplasty (ptca) or stent placement), within 30 days prior to enrollment or subject has evidence of new ischemic changes on screening 12-lead ecg
Beschreibung

Myocardial Infarction | Acute Coronary Syndrome | Cardiac Surgery | Percutaneous Transluminal Coronary Angioplasty | Placement of stent | Ischemic Change 12 lead ECG

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0018821
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0522776
UMLS CUI [6,1]
C2826576
UMLS CUI [6,2]
C0430456
subject has troponin i or t levels beyond the upper limit of normal for the local lab
Beschreibung

Troponin I increased | Troponin T increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1141949
UMLS CUI [2]
C1142294
subject has significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1883524
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0031048
subject has failed electrical cardioversion for af at anytime
Beschreibung

Electric Countershock failed Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0004238
subject has failed pharmacologic conversion with an intravenous class i or class iii antiarrhythmic drug for this episode of af
Beschreibung

Conversion pharmacological failed | Anti-Arrhythmia Agents Intravenous Class | Episode of Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439836
UMLS CUI [1,2]
C0205464
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0456387
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0004238
subject has any known reversible causes of af such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia
Beschreibung

Cause Reversible Atrial Fibrillation | Alcoholic Intoxication | Pulmonary Embolism | Hyperthyroidism | Pericarditis | Hypoxemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2]
C0001969
UMLS CUI [3]
C0034065
UMLS CUI [4]
C0020550
UMLS CUI [5]
C0031046
UMLS CUI [6]
C0700292
subject has uncorrected electrolyte imbalance
Beschreibung

Electrolyte imbalance uncorrected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0342579
UMLS CUI [1,2]
C4072785
subject has clinical evidence of digoxin toxicity
Beschreibung

Poisoning by digoxin

Datentyp

boolean

Alias
UMLS CUI [1]
C0274727
subject has a history of clinically significant illness (e.g. neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, endocrine, hematological, or psychiatric), medical condition or laboratory abnormality within 4 weeks prior to screening
Beschreibung

Illness Clinical Significance | Nervous system disorder | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Lung diseases | Metabolic Diseases | Endocrine System Diseases | Hematological Disease | Mental disorders | Medical condition Clinical Significance | Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0004936
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C2826293
UMLS CUI [12]
C0438215
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00989001

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy Absent | Breast Feeding Absent | Premenopausal state Contraceptive methods
Item
females must be not pregnant or nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30 days post study treatment
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
ATRIAL FIBRILLATION SYMPTOMATIC Onset Recent | Conversion Sinus rhythm
Item
subject must have recent onset (> 3 hours to <= 7 days) symptomatic af to be best managed by acute conversion to sr
boolean
C0741283 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0439836 (UMLS CUI [2,1])
C0232201 (UMLS CUI [2,2])
Anticoagulant therapy
Item
subject must have adequate anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
subject must have systolic blood pressure (sbp) above 90 mmhg and less than 160 mmhg and diastolic blood pressure (dbp) less than 95 mmhg at screening and baseline
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Body Weight
Item
subject must have a body weight between 45 and 136 kg, inclusive (99 and 300 lbs)
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart failure | Ventricular Dysfunction, Left
Item
subject has a history of heart failure or documentation of left ventricular dysfunction
boolean
C0018801 (UMLS CUI [1])
C0242698 (UMLS CUI [2])
Prolonged QT interval | Prolonged QT interval Suspected | QT interval uncorrected
Item
subject has known or suspected prolonged qt or uncorrected qt interval of > 0.440 sec
boolean
C0151878 (UMLS CUI [1])
C0151878 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0429028 (UMLS CUI [3,1])
C4072785 (UMLS CUI [3,2])
BRADYCARDIA SYMPTOMATIC | Ventricular Heart Rate | Exception Controlled by Artificial cardiac pacemaker
Item
subject has symptomatic bradycardia or ventricular rate less than 50 bpm at screening, unless controlled by a pacemaker
boolean
C0741627 (UMLS CUI [1])
C1883530 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0332298 (UMLS CUI [3,2])
C0030163 (UMLS CUI [3,3])
Bradycardia | Hypotension | Systolic Pressure | Status post Receive Loading dose | Status post Receive Bolus Dosing Unit | Infusion Rate Control Pharmaceutical Preparations
Item
subject has bradycardia (heart rate less than 50 bpm) or hypotension (sbp less that 90 mmhg) after receiving a loading, bolus dose, or sustained infusion of any rate control medication during screening
boolean
C0428977 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C3714444 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
C1705509 (UMLS CUI [5,3])
C0574032 (UMLS CUI [6,1])
C1521828 (UMLS CUI [6,2])
C2587213 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
QRS interval | Exception Artificial cardiac pacemaker Present
Item
subject has a qrs interval > 0.14 sec., unless subject has a pacemaker
boolean
C0520880 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030163 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Myocardial Infarction | Acute Coronary Syndrome | Cardiac Surgery | Percutaneous Transluminal Coronary Angioplasty | Placement of stent | Ischemic Change 12 lead ECG
Item
subject had a myocardial infarction (mi), acute coronary syndrome, cardiac surgery (including percutaneous transluminal coronary angioplasty (ptca) or stent placement), within 30 days prior to enrollment or subject has evidence of new ischemic changes on screening 12-lead ecg
boolean
C0027051 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0522776 (UMLS CUI [5])
C2826576 (UMLS CUI [6,1])
C0430456 (UMLS CUI [6,2])
Troponin I increased | Troponin T increased
Item
subject has troponin i or t levels beyond the upper limit of normal for the local lab
boolean
C1141949 (UMLS CUI [1])
C1142294 (UMLS CUI [2])
Valvular stenosis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Pericarditis, Constrictive
Item
subject has 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])
Electric Countershock failed Atrial Fibrillation
Item
subject has failed electrical cardioversion for af at anytime
boolean
C0013778 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Conversion pharmacological failed | Anti-Arrhythmia Agents Intravenous Class | Episode of Atrial Fibrillation
Item
subject has failed pharmacologic conversion with an intravenous class i or class iii antiarrhythmic drug for this episode of af
boolean
C0439836 (UMLS CUI [1,1])
C0205464 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
Cause Reversible Atrial Fibrillation | Alcoholic Intoxication | Pulmonary Embolism | Hyperthyroidism | Pericarditis | Hypoxemia
Item
subject has any known reversible causes of af such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0001969 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0031046 (UMLS CUI [5])
C0700292 (UMLS CUI [6])
Electrolyte imbalance uncorrected
Item
subject has uncorrected electrolyte imbalance
boolean
C0342579 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Poisoning by digoxin
Item
subject has clinical evidence of digoxin toxicity
boolean
C0274727 (UMLS CUI [1])
Illness Clinical Significance | Nervous system disorder | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Lung diseases | Metabolic Diseases | Endocrine System Diseases | Hematological Disease | Mental disorders | Medical condition Clinical Significance | Laboratory test result abnormal
Item
subject has a history of clinically significant illness (e.g. neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, endocrine, hematological, or psychiatric), medical condition or laboratory abnormality within 4 weeks prior to screening
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0025517 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0004936 (UMLS CUI [10])
C3843040 (UMLS CUI [11,1])
C2826293 (UMLS CUI [11,2])
C0438215 (UMLS CUI [12])
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