ID

34835

Description

Comparison Between Thoracoscopic Left Atrial Appendage Excision and Warfarin for the Secondary Prevention of Stroke in Patients With AF; ODM derived from: https://clinicaltrials.gov/show/NCT02478294

Link

https://clinicaltrials.gov/show/NCT02478294

Keywords

  1. 1/30/19 1/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 30, 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.

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 NCT02478294

Eligibility Atrial Fibrillation NCT02478294

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have documented af episodes
Description

Episodes Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0004238
the occurrence of ischemic stroke, tia or systemic thromboembolism in the previous 1-6 months
Description

Ischemic stroke | Transient Ischemic Attack | Thromboembolism Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0007787
UMLS CUI [3,1]
C0040038
UMLS CUI [3,2]
C0205373
having at least one of the following major risk factors of stroke: ht, dm, or hf, or having two of the following minor factors of stroke: ≥65 y, vascular disease, or female
Description

Risk factors Major Cerebrovascular accident | Hormone Therapy | Diabetes Mellitus | Heart failure | Risk factors Minor Cerebrovascular accident | Age | Vascular Diseases | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0038454
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0018801
UMLS CUI [5,1]
C0035648
UMLS CUI [5,2]
C0205165
UMLS CUI [5,3]
C0038454
UMLS CUI [6]
C0001779
UMLS CUI [7]
C0042373
UMLS CUI [8]
C0079399
capable of understanding and signing the crf
Description

Case Report Form Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
reversible af
Description

Atrial Fibrillation Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205343
modified rankin score ≥4
Description

Modified Rankin score

Data type

boolean

Alias
UMLS CUI [1]
C3888574
having a history of rheumatic, severe valvular heart disease or heart valve replacement
Description

Rheumatism | Heart valve disease Severe | Heart valve replacement

Data type

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0190173
having symptomatic carotid artery disease
Description

Carotid Artery Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0007273
UMLS CUI [1,2]
C0231220
having another disease which requires lifelong warfarin therapy
Description

Disease Requiring Warfarin therapy Lifelong

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C4303340
UMLS CUI [1,4]
C4274169
medical conditions limiting expected survival to <1 year
Description

Medical condition Limiting Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
women of childbearing potential (unless post-menopausal or surgically sterile)
Description

Childbearing Potential | Exception Postmenopausal state | Exception Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0232970
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015787
participation in any other clinical mortality trial
Description

Study Subject Participation Status | Clinical Trial Mortality

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0178686
unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Atrial Fibrillation NCT02478294

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18-80 years
boolean
C0001779 (UMLS CUI [1])
Episodes Atrial Fibrillation
Item
have documented af episodes
boolean
C0332189 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
Ischemic stroke | Transient Ischemic Attack | Thromboembolism Systemic
Item
the occurrence of ischemic stroke, tia or systemic thromboembolism in the previous 1-6 months
boolean
C0948008 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0040038 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Risk factors Major Cerebrovascular accident | Hormone Therapy | Diabetes Mellitus | Heart failure | Risk factors Minor Cerebrovascular accident | Age | Vascular Diseases | Gender
Item
having at least one of the following major risk factors of stroke: ht, dm, or hf, or having two of the following minor factors of stroke: ≥65 y, vascular disease, or female
boolean
C0035648 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0035648 (UMLS CUI [5,1])
C0205165 (UMLS CUI [5,2])
C0038454 (UMLS CUI [5,3])
C0001779 (UMLS CUI [6])
C0042373 (UMLS CUI [7])
C0079399 (UMLS CUI [8])
Case Report Form Completion
Item
capable of understanding and signing the crf
boolean
C1516308 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Reversible
Item
reversible af
boolean
C0004238 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
Modified Rankin score
Item
modified rankin score ≥4
boolean
C3888574 (UMLS CUI [1])
Rheumatism | Heart valve disease Severe | Heart valve replacement
Item
having a history of rheumatic, severe valvular heart disease or heart valve replacement
boolean
C0035435 (UMLS CUI [1])
C0018824 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0190173 (UMLS CUI [3])
Carotid Artery Disease Symptomatic
Item
having symptomatic carotid artery disease
boolean
C0007273 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Disease Requiring Warfarin therapy Lifelong
Item
having another disease which requires lifelong warfarin therapy
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4303340 (UMLS CUI [1,3])
C4274169 (UMLS CUI [1,4])
Medical condition Limiting Life Expectancy
Item
medical conditions limiting expected survival to <1 year
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Childbearing Potential | Exception Postmenopausal state | Exception Female Sterilization
Item
women of childbearing potential (unless post-menopausal or surgically sterile)
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0015787 (UMLS CUI [3,2])
Study Subject Participation Status | Clinical Trial Mortality
Item
participation in any other clinical mortality trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0178686 (UMLS CUI [2,2])
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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