ID

37527

Beskrivning

A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055); ODM derived from: https://clinicaltrials.gov/show/NCT01627106

Länk

https://clinicaltrials.gov/show/NCT01627106

Nyckelord

Versioner (1)
  1. 2019-08-05 2019-08-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 augusti 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Atrial Fibrillation NCT01627106

Engelsk

Eligibility Atrial Fibrillation NCT01627106

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic af (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
Beskrivning

ATRIAL FIBRILLATION SYMPTOMATIC Episode Duration | Hemodynamics Stable | Absence Comorbidity Resulting in Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0019010
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0009488
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0019993
if female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
Beskrivning

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
weigh at least 45 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
receiving adequate anticoagulant therapy
Beskrivning

Anticoagulant therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0150457
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
Beskrivning

Hypersensitivity Vernakalant | Amiodarone allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium Chloride | Hypersensitivity Sodium Hydroxide | Iodine allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2001572
UMLS CUI [2]
C0571891
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0055819
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0037494
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0037517
UMLS CUI [6]
C0571818
severe aortic stenosis
Beskrivning

Aortic stenosis, severe

Datatyp

boolean

Alias
UMLS CUI [1]
C3806272
systolic blood pressure <100 mmhg
Beskrivning

Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
new york heart association (nyha) class iii or iv heart failure
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
Beskrivning

Bradycardia, severe | Sinus Node Dysfunction | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C4313412
UMLS CUI [2]
C0428908
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5,1]
C0030163
UMLS CUI [5,2]
C0332197
use of iv rhythm control anti-arrhythmics (class i and iii) within 4 hours of study drug administration
Beskrivning

Rhythm Control Intravenous | Anti-Arrhythmia Agents Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871269
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C0348016
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0456387
acute coronary syndrome (including myocardial infarction) within previous 30 days
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
history of thyroid dysfunction
Beskrivning

Thyroid dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0348024
severe acute respiratory failure or cardiovascular collapse
Beskrivning

Respiratory Failure Severe | Cardiovascular collapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1145670
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0036974
participating in another drug study or has received an investigational drug within 30 days prior to enrollment
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
Beskrivning

Pregnancy | Breast Feeding | Pregnancy Expected

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
Tillbaka till toppen

Similar models

Eligibility Atrial Fibrillation NCT01627106

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ATRIAL FIBRILLATION SYMPTOMATIC Episode Duration | Hemodynamics Stable | Absence Comorbidity Resulting in Hospitalization
Item
symptomatic af (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
boolean
C0741283 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0019010 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0019993 (UMLS CUI [3,4])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
if female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Body Weight
Item
weigh at least 45 kg
boolean
C0005910 (UMLS CUI [1])
Anticoagulant therapy
Item
receiving adequate anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Vernakalant | Amiodarone allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium Chloride | Hypersensitivity Sodium Hydroxide | Iodine allergy
Item
hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
boolean
C0020517 (UMLS CUI [1,1])
C2001572 (UMLS CUI [1,2])
C0571891 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0055819 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0037494 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0037517 (UMLS CUI [5,2])
C0571818 (UMLS CUI [6])
Aortic stenosis, severe
Item
severe aortic stenosis
boolean
C3806272 (UMLS CUI [1])
Systolic Pressure
Item
systolic blood pressure <100 mmhg
boolean
C0871470 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
new york heart association (nyha) class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Bradycardia, severe | Sinus Node Dysfunction | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
boolean
C4313412 (UMLS CUI [1])
C0428908 (UMLS CUI [2])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0030163 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Rhythm Control Intravenous | Anti-Arrhythmia Agents Class
Item
use of iv rhythm control anti-arrhythmics (class i and iii) within 4 hours of study drug administration
boolean
C0871269 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0348016 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
Acute Coronary Syndrome | Myocardial Infarction
Item
acute coronary syndrome (including myocardial infarction) within previous 30 days
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Thyroid dysfunction
Item
history of thyroid dysfunction
boolean
C0348024 (UMLS CUI [1])
Respiratory Failure Severe | Cardiovascular collapse
Item
severe acute respiratory failure or cardiovascular collapse
boolean
C1145670 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0036974 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participating in another drug study or has received an investigational drug within 30 days prior to enrollment
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy Expected
Item
pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial