ID

39510

Beskrivning

LifeVest Trends Validation Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT02149290

Länk

https://clinicaltrials.gov/show/NCT02149290

Nyckelord

  1. 2020-01-20 2020-01-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 januari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Heart Failure NCT02149290

Eligibility Heart Failure NCT02149290

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic heart failure (i.e., new york heart association (nyha) class ii or higher)
Beskrivning

Heart failure Symptomatic New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
evidence of a prior myocardial infarction (mi) or dilated cardiomyopathy
Beskrivning

Myocardial Infarction | Cardiomyopathy, Dilated

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0007193
ejection fraction of 35% or less at the start of wcd use
Beskrivning

Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
anticipated to need a wcd for three months or more
Beskrivning

Patient need for Wearable cardioverter-defibrillator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C2203005
at least 18 years of age (over the legal age of providing consent)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of an implantable cardioverter defibrillator (icd), recent removal of an icd, or planned use of an icd within the next three months
Beskrivning

Implantable defibrillator | Implantable defibrillator removal | Implantable defibrillator Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0948934
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C1301732
need for an assistive device for ambulation (wheelchair, walker, or cane)
Beskrivning

Patient need for Assistive Device Ambulation | Wheelchair | Walker | Cane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0945826
UMLS CUI [2]
C0043143
UMLS CUI [3]
C0043016
UMLS CUI [4]
C0006856
use of a unipolar pacemaker
Beskrivning

Artificial cardiac pacemaker Unipolar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0443340
physical or mental conditions that prevent interaction with or wearing of the device
Beskrivning

Physical Condition Preventing Use of Device | Mental condition Preventing Use of Device

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0699733
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1524063
UMLS CUI [2,4]
C0699733
advanced directive prohibiting resuscitation
Beskrivning

Advance Directive Preventing Resuscitation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001683
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0035273
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Heart Failure NCT02149290

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Symptomatic New York Heart Association Classification
Item
symptomatic heart failure (i.e., new york heart association (nyha) class ii or higher)
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Myocardial Infarction | Cardiomyopathy, Dilated
Item
evidence of a prior myocardial infarction (mi) or dilated cardiomyopathy
boolean
C0027051 (UMLS CUI [1])
C0007193 (UMLS CUI [2])
Cardiac ejection fraction
Item
ejection fraction of 35% or less at the start of wcd use
boolean
C0232174 (UMLS CUI [1])
Patient need for Wearable cardioverter-defibrillator
Item
anticipated to need a wcd for three months or more
boolean
C0686904 (UMLS CUI [1,1])
C2203005 (UMLS CUI [1,2])
Age
Item
at least 18 years of age (over the legal age of providing consent)
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Implantable defibrillator | Implantable defibrillator removal | Implantable defibrillator Planned
Item
use of an implantable cardioverter defibrillator (icd), recent removal of an icd, or planned use of an icd within the next three months
boolean
C0162589 (UMLS CUI [1])
C0948934 (UMLS CUI [2])
C0162589 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Patient need for Assistive Device Ambulation | Wheelchair | Walker | Cane
Item
need for an assistive device for ambulation (wheelchair, walker, or cane)
boolean
C0686904 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0945826 (UMLS CUI [1,3])
C0043143 (UMLS CUI [2])
C0043016 (UMLS CUI [3])
C0006856 (UMLS CUI [4])
Artificial cardiac pacemaker Unipolar
Item
use of a unipolar pacemaker
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
Physical Condition Preventing Use of Device | Mental condition Preventing Use of Device
Item
physical or mental conditions that prevent interaction with or wearing of the device
boolean
C3714565 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0699733 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0699733 (UMLS CUI [2,4])
Advance Directive Preventing Resuscitation
Item
advanced directive prohibiting resuscitation
boolean
C0001683 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0035273 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])

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