ID

39152

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01779856

Palavras-chave

Versões (1)
  1. 05/12/2019 05/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01779856

Inglês

Eligibility End Stage Renal Disease NCT01779856

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Age | Insertion Implantable cardiac monitor Willing

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

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

Study Subject Participation Status | Interventional Study Interferes with Dialysis Monitoring

Tipo de dados

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
Descrição

Patient Inappropriate Insertion Implantable cardiac monitor

Tipo de dados

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
Descrição

Hemodialysis catheter Interferes with Implantable cardiac monitor Site

Tipo de dados

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
Descrição

Recent infection

Tipo de dados

boolean

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

Hemodialysis | Hemoglobin measurement

Tipo de dados

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
Descrição

End Stage Hepatic Failure | Thoracic Surgical Procedures

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Kidney Transplantation Scheduled | Kidney Transplantation Likely

Tipo de dados

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
Descrição

Hemodialysis, Home

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019008
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Similar models

Eligibility End Stage Renal Disease NCT01779856

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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