ID

31494

Description

Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA); ODM derived from: https://clinicaltrials.gov/show/NCT00623779

Link

https://clinicaltrials.gov/show/NCT00623779

Keywords

  1. 8/28/18 8/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 28, 2018

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.

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 Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

Eligibility Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
either one of the following risk factors is sufficient for inclusion (high risk patient)
Description

Risk factors Quantity | High risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0030705
previous cerebral ischaemic attack (stroke or transient ischaemic attack (tia), >30 days prior to randomization)
Description

Ischemic attack cerebral Previous | Cerebrovascular accident Previous | Transient Ischemic Attack Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0745413
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0007787
UMLS CUI [3,2]
C0205156
previous systemic embolism or at least one of the following risk factors are needed for inclusion: age ≥75 years
Description

Embolism Systemic Previous | Risk factors Quantity | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0013922
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0001779
symptomatic congestive heart failure
Description

Symptomatic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0742758
impaired left ventricular systolic function
Description

LEFT VENTRICULAR SYSTOLIC DYSFUNCTION

Data type

boolean

Alias
UMLS CUI [1]
C0745679
diabetes mellitus; hypertension requiring anti-hypertensive treatment
Description

Diabetes Mellitus | Hypertensive disease Requirement Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0585941
in addition to af the patient must be appropriate for but unable or unwilling to take vka therapy
Description

Atrial Fibrillation | Patients Appropriate Treatment with Vitamin K antagonist | Treatment with Vitamin K antagonist Unable | Treatment with Vitamin K antagonist Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1096489
UMLS CUI [3,1]
C1096489
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C1096489
UMLS CUI [4,2]
C0558080
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of a clinically significant valvular heart disease;; stroke or tia and/or systemic embolism within the previous 30 days prior to randomization
Description

Heart valve disease | Cerebrovascular accident | Transient Ischemic Attack | Embolism Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4,1]
C0013922
UMLS CUI [4,2]
C0205373
conditions associated with increased risk of major bleeding
Description

Condition Associated with Bleeding risk | Risk Increased Hemorrhage Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C3251812
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0019080
UMLS CUI [2,4]
C0205164

Similar models

Eligibility Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Risk factors Quantity | High risk Patient
Item
either one of the following risk factors is sufficient for inclusion (high risk patient)
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
Ischemic attack cerebral Previous | Cerebrovascular accident Previous | Transient Ischemic Attack Previous
Item
previous cerebral ischaemic attack (stroke or transient ischaemic attack (tia), >30 days prior to randomization)
boolean
C0745413 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0007787 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Embolism Systemic Previous | Risk factors Quantity | Age
Item
previous systemic embolism or at least one of the following risk factors are needed for inclusion: age ≥75 years
boolean
C0013922 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Symptomatic congestive heart failure
Item
symptomatic congestive heart failure
boolean
C0742758 (UMLS CUI [1])
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
Item
impaired left ventricular systolic function
boolean
C0745679 (UMLS CUI [1])
Diabetes Mellitus | Hypertensive disease Requirement Antihypertensive therapy
Item
diabetes mellitus; hypertension requiring anti-hypertensive treatment
boolean
C0011849 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0585941 (UMLS CUI [2,3])
Atrial Fibrillation | Patients Appropriate Treatment with Vitamin K antagonist | Treatment with Vitamin K antagonist Unable | Treatment with Vitamin K antagonist Unwilling
Item
in addition to af the patient must be appropriate for but unable or unwilling to take vka therapy
boolean
C0004238 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1096489 (UMLS CUI [2,3])
C1096489 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C1096489 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Heart valve disease | Cerebrovascular accident | Transient Ischemic Attack | Embolism Systemic
Item
presence of a clinically significant valvular heart disease;; stroke or tia and/or systemic embolism within the previous 30 days prior to randomization
boolean
C0018824 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0013922 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Condition Associated with Bleeding risk | Risk Increased Hemorrhage Major
Item
conditions associated with increased risk of major bleeding
boolean
C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])

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

Fields marked with * are required.

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