ID

37601

Description

Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01994070

Link

https://clinicaltrials.gov/show/NCT01994070

Keywords

Versions (1)
  1. 8/10/19 8/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 10, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT01994070

English

Eligibility Atrial Fibrillation NCT01994070

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have an abnormal heart rhythm diagnosed as af for less than 48 hours.
Description

Cardiac Arrhythmia | Atrial Fibrillation Duration

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0449238
be eligible for cardioversion (in the judgment of the study doctor).
Description

Eligibility Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0013778
are on the appropriate blood thinner medications.
Description

Anticoagulants Appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C1548787
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.
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
are adequately hydrated (in the judgment of the study doctor) and have a normal saline intravenous established and it is working properly.
Description

Hydration status | Normal saline Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C1321013
UMLS CUI [2,1]
C0445115
UMLS CUI [2,2]
C0348016
must have a body weight between 45 and 136 kg inclusive (99 and 300 lbs).
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
be able and willing to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing a child
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
are diagnosed with any other serious lung, liver, metabolic, kidney, gastrointestinal, central nervous system, or psychiatric disease, infection, having a fever, end stage disease states, or any other diseases that could interfere with the conduct of this study. your study doctor will confirm this with you.
Description

Lung disease Serious | Liver disease Serious | Metabolic Disease Serious | Kidney Disease Serious | Gastrointestinal Disease Serious | CNS disorder Serious | Mental disorders Serious | Communicable Disease | Fever | Terminal illness | Disease Interferes with Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0025517
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205404
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0007682
UMLS CUI [6,2]
C0205404
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0205404
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0015967
UMLS CUI [10]
C0679247
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C2732579
have an infection or fever
Description

Communicable Disease | Fever

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
are allergic to procainamide (the chemical conversion agent) or propofol (the sedative agent)
Description

Procainamide allergy | Propofol allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571885
UMLS CUI [2]
C0570632
are participating in another drug study or have received an experimental drug within 30 days prior to screening in this study
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
are not currently living in the vancouver coastal health region
Description

Residence Remote

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
are unable or unwilling to be contacted at 30 days by one of the study doctors or study staff to determine 30-day outcomes
Description

Contact with Research Personnel Unable | Contact with Research Personnel Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0332158
UMLS CUI [2,2]
C0035173
UMLS CUI [2,3]
C0558080
are unwilling to sign the informed consent form
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
are unable to speak english
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
Back to the top of the page

Similar models

Eligibility Atrial Fibrillation NCT01994070

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Arrhythmia | Atrial Fibrillation Duration
Item
must have an abnormal heart rhythm diagnosed as af for less than 48 hours.
boolean
C0003811 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Eligibility Electric Countershock
Item
be eligible for cardioversion (in the judgment of the study doctor).
boolean
C1548635 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
Anticoagulants Appropriate
Item
are on the appropriate blood thinner medications.
boolean
C0003280 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
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])
Hydration status | Normal saline Intravenous
Item
are adequately hydrated (in the judgment of the study doctor) and have a normal saline intravenous established and it is working properly.
boolean
C1321013 (UMLS CUI [1])
C0445115 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
Body Weight
Item
must have a body weight between 45 and 136 kg inclusive (99 and 300 lbs).
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
be able and willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing a child
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lung disease Serious | Liver disease Serious | Metabolic Disease Serious | Kidney Disease Serious | Gastrointestinal Disease Serious | CNS disorder Serious | Mental disorders Serious | Communicable Disease | Fever | Terminal illness | Disease Interferes with Completion of clinical trial
Item
are diagnosed with any other serious lung, liver, metabolic, kidney, gastrointestinal, central nervous system, or psychiatric disease, infection, having a fever, end stage disease states, or any other diseases that could interfere with the conduct of this study. your study doctor will confirm this with you.
boolean
C0024115 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0025517 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0017178 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0007682 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8])
C0015967 (UMLS CUI [9])
C0679247 (UMLS CUI [10])
C0012634 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C2732579 (UMLS CUI [11,3])
Communicable Disease | Fever
Item
have an infection or fever
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Procainamide allergy | Propofol allergy
Item
are allergic to procainamide (the chemical conversion agent) or propofol (the sedative agent)
boolean
C0571885 (UMLS CUI [1])
C0570632 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
are participating in another drug study or have received an experimental drug within 30 days prior to screening in this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Residence Remote
Item
are not currently living in the vancouver coastal health region
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
Contact with Research Personnel Unable | Contact with Research Personnel Unwilling
Item
are unable or unwilling to be contacted at 30 days by one of the study doctors or study staff to determine 30-day outcomes
boolean
C0332158 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332158 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Informed Consent Unwilling
Item
are unwilling to sign the informed consent form
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Lacking Able to speak English Language
Item
are unable to speak english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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