ID

34835

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02478294

Nyckelord

Versioner (1)
  1. 2019-01-30 2019-01-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02478294

Engelsk

Eligibility Atrial Fibrillation NCT02478294

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-80 years
Beskrivning

Age

Datatyp

boolean

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

Episodes Atrial Fibrillation

Datatyp

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
Beskrivning

Ischemic stroke | Transient Ischemic Attack | Thromboembolism Systemic

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Case Report Form Completion

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
reversible af
Beskrivning

Atrial Fibrillation Reversible

Datatyp

boolean

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

Modified Rankin score

Datatyp

boolean

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

Rheumatism | Heart valve disease Severe | Heart valve replacement

Datatyp

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
Beskrivning

Carotid Artery Disease Symptomatic

Datatyp

boolean

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

Disease Requiring Warfarin therapy Lifelong

Datatyp

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
Beskrivning

Medical condition Limiting Life Expectancy

Datatyp

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)
Beskrivning

Childbearing Potential | Exception Postmenopausal state | Exception Female Sterilization

Datatyp

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
Beskrivning

Study Subject Participation Status | Clinical Trial Mortality

Datatyp

boolean

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

Informed Consent Unable

Datatyp

boolean

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

Eligibility Atrial Fibrillation NCT02478294

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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