ID

40861

Beschrijving

Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.; ODM derived from: https://clinicaltrials.gov/show/NCT02127307

Link

https://clinicaltrials.gov/show/NCT02127307

Trefwoorden

Versies (1)
  1. 27-05-20 27-05-20 -
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See clinicaltrials.gov

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27 mei 2020

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Creative Commons BY 4.0
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Eligibility Heart Failure (HF) NCT02127307

Engels

Eligibility Heart Failure (HF) NCT02127307

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject was a hf subject who had signed informed consent for mbg311 or mbg312.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
the subject was administered adreview™ in mbg311 or mbg312.
Beschrijving

AdreView

Datatype

boolean

Alias
UMLS CUI [1]
C2586540
the subject completed the late planar imaging assessments (at a minimum) required by the protocols for mbg311 and mbg312, and those images were read and judged diagnostic by at least 2 blinded readers.
Beschrijving

Planar Imaging Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986801
UMLS CUI [1,2]
C0205197
in addition, all subjects must meet 1 of the following 3 inclusion criteria.
Beschrijving

Inclusion criteria Quantity Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
if the subject can be located, he/she provides informed consent to allow the investigator access to medical records and/or gives permission for the investigator to speak to treating physicians.
Beschrijving

Informed Consent | Access Medical Records

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0025102
if the subject can be located and he/she declines to provide informed consent, the irb/ec provides a waiver of consent to allow the investigator to record that the subject is alive.
Beschrijving

Informed Consent Refused | Waiver Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [2,1]
C3827528
UMLS CUI [2,2]
C0021430
if the subject cannot be located, the irb/ec provides a waiver of consent to allow the investigator to access available medical records for care provided subsequent to last date of subject participation in mbg311, mbg312, and/or mbg313 and/or to allow collection of data from publicly available sources.
Beschrijving

Study Subject Unavailable | Access Medical Records

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0686905
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0025102
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject withdrew or was withdrawn from mbg311 or mbg312 because of a protocol violation.
Beschrijving

Patient withdrawn from trial Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
the subject underwent heart transplantation during mbg311, mbg312, or mbg313.
Beschrijving

Heart Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0018823
the subject was recorded to have died during mbg311, mbg312, or mbg313.
Beschrijving

Patient died

Datatype

boolean

Alias
UMLS CUI [1]
C1306577
the subject voluntarily withdrew from mbg311, mbg312, or mbg313, and the irb/ec has not provided a waiver to allow recording of subject survival status in such an instance.
Beschrijving

Patient withdrawn from trial Specified Voluntary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0439656
the subject cannot be located, cannot be contacted, and no information can be found to establish survival status beyond the date of last contact in mbg311, mbg312, or mbg313, including information available as a result of an irb/ec-approved waiver.
Beschrijving

Study Subject Unavailable | Survival Status Information Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0686905
UMLS CUI [2,1]
C1148433
UMLS CUI [2,2]
C1533716
UMLS CUI [2,3]
C0332268
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Similar models

Eligibility Heart Failure (HF) NCT02127307

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
the subject was a hf subject who had signed informed consent for mbg311 or mbg312.
boolean
C0021430 (UMLS CUI [1])
AdreView
Item
the subject was administered adreview™ in mbg311 or mbg312.
boolean
C2586540 (UMLS CUI [1])
Planar Imaging Completed
Item
the subject completed the late planar imaging assessments (at a minimum) required by the protocols for mbg311 and mbg312, and those images were read and judged diagnostic by at least 2 blinded readers.
boolean
C2986801 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Inclusion criteria Quantity Fulfill
Item
in addition, all subjects must meet 1 of the following 3 inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent | Access Medical Records
Item
if the subject can be located, he/she provides informed consent to allow the investigator access to medical records and/or gives permission for the investigator to speak to treating physicians.
boolean
C0021430 (UMLS CUI [1])
C0444454 (UMLS CUI [2,1])
C0025102 (UMLS CUI [2,2])
Informed Consent Refused | Waiver Consent
Item
if the subject can be located and he/she declines to provide informed consent, the irb/ec provides a waiver of consent to allow the investigator to record that the subject is alive.
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C3827528 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Study Subject Unavailable | Access Medical Records
Item
if the subject cannot be located, the irb/ec provides a waiver of consent to allow the investigator to access available medical records for care provided subsequent to last date of subject participation in mbg311, mbg312, and/or mbg313 and/or to allow collection of data from publicly available sources.
boolean
C0681850 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0025102 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patient withdrawn from trial Specified
Item
the subject withdrew or was withdrawn from mbg311 or mbg312 because of a protocol violation.
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Heart Transplantation
Item
the subject underwent heart transplantation during mbg311, mbg312, or mbg313.
boolean
C0018823 (UMLS CUI [1])
Patient died
Item
the subject was recorded to have died during mbg311, mbg312, or mbg313.
boolean
C1306577 (UMLS CUI [1])
Patient withdrawn from trial Specified Voluntary
Item
the subject voluntarily withdrew from mbg311, mbg312, or mbg313, and the irb/ec has not provided a waiver to allow recording of subject survival status in such an instance.
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0439656 (UMLS CUI [1,3])
Study Subject Unavailable | Survival Status Information Lacking
Item
the subject cannot be located, cannot be contacted, and no information can be found to establish survival status beyond the date of last contact in mbg311, mbg312, or mbg313, including information available as a result of an irb/ec-approved waiver.
boolean
C0681850 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C1148433 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
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