ID

39152

Beskrivning

Study the Characteristics of Cardiac Related Events in Hemodialysis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01779856

Länk

https://clinicaltrials.gov/show/NCT01779856

Nyckelord

Versioner (1)
  1. 2019-12-05 2019-12-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01779856

Engelsk

Eligibility End Stage Renal Disease NCT01779856

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
21 years of age or older and is willing to be implanted with the reveal icm
Beskrivning

Age | Insertion Implantable cardiac monitor Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C3879681
UMLS CUI [2,3]
C0600109
currently on hemodialysis at least three times per week or has an estimated glomerular filtration rate (egfr) of < 15 ml/min/1.73m^2 and is expected to begin hemodialysis within 2 months.
Beskrivning

Hemodialysis times per week | Estimated Glomerular Filtration Rate | Hemodialysis Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0456698
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C0019004
UMLS CUI [3,2]
C1517001
subject is willing and able to comply with the protocol
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently enrolled in an interventional study that may interfere with the monitoring in dialysis protocol
Beskrivning

Study Subject Participation Status | Interventional Study Interferes with Dialysis Monitoring

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3274035
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0011946
UMLS CUI [2,4]
C1283169
not suitable for reveal icm implantation
Beskrivning

Patient Inappropriate Insertion Implantable cardiac monitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0021107
UMLS CUI [1,4]
C3879681
has an existing hemodialysis catheter that may interfere with the reveal icm implantation site
Beskrivning

Hemodialysis catheter Interferes with Implantable cardiac monitor Site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0179760
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3879681
UMLS CUI [1,4]
C1515974
has a recent infection
Beskrivning

Recent infection

Datatyp

boolean

Alias
UMLS CUI [1]
C2169571
is currently on hemodialysis with a hemoglobin < 10 g/dl
Beskrivning

Hemodialysis | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0518015
has end-stage liver failure or has had thoracic surgery within the past 6 months
Beskrivning

End Stage Hepatic Failure | Thoracic Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0524832
has an existing pacemaker, implantable cardioverter-defibrillator (icd) or cardiac resynchronization device
Beskrivning

Artificial cardiac pacemaker | Implantable defibrillator | Cardiac resynchronization therapy implantable defibrillator

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C3874742
is scheduled for renal transplantation or will likely be transplanted within 6 months
Beskrivning

Kidney Transplantation Scheduled | Kidney Transplantation Likely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0750492
is currently on home hemodialysis
Beskrivning

Hemodialysis, Home

Datatyp

boolean

Alias
UMLS CUI [1]
C0019008
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Similar models

Eligibility End Stage Renal Disease NCT01779856

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Insertion Implantable cardiac monitor Willing
Item
21 years of age or older and is willing to be implanted with the reveal icm
boolean
C0001779 (UMLS CUI [1])
C0021107 (UMLS CUI [2,1])
C3879681 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Hemodialysis times per week | Estimated Glomerular Filtration Rate | Hemodialysis Expected
Item
currently on hemodialysis at least three times per week or has an estimated glomerular filtration rate (egfr) of < 15 ml/min/1.73m^2 and is expected to begin hemodialysis within 2 months.
boolean
C0019004 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0019004 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Protocol Compliance
Item
subject is willing and able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Interventional Study Interferes with Dialysis Monitoring
Item
currently enrolled in an interventional study that may interfere with the monitoring in dialysis protocol
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
C1283169 (UMLS CUI [2,4])
Patient Inappropriate Insertion Implantable cardiac monitor
Item
not suitable for reveal icm implantation
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
C3879681 (UMLS CUI [1,4])
Hemodialysis catheter Interferes with Implantable cardiac monitor Site
Item
has an existing hemodialysis catheter that may interfere with the reveal icm implantation site
boolean
C0179760 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3879681 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Recent infection
Item
has a recent infection
boolean
C2169571 (UMLS CUI [1])
Hemodialysis | Hemoglobin measurement
Item
is currently on hemodialysis with a hemoglobin < 10 g/dl
boolean
C0019004 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
End Stage Hepatic Failure | Thoracic Surgical Procedures
Item
has end-stage liver failure or has had thoracic surgery within the past 6 months
boolean
C0745744 (UMLS CUI [1])
C0524832 (UMLS CUI [2])
Artificial cardiac pacemaker | Implantable defibrillator | Cardiac resynchronization therapy implantable defibrillator
Item
has an existing pacemaker, implantable cardioverter-defibrillator (icd) or cardiac resynchronization device
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C3874742 (UMLS CUI [3])
Kidney Transplantation Scheduled | Kidney Transplantation Likely
Item
is scheduled for renal transplantation or will likely be transplanted within 6 months
boolean
C0022671 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
Hemodialysis, Home
Item
is currently on home hemodialysis
boolean
C0019008 (UMLS CUI [1])
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