Informationen:
Fehler:
ID
40861
Beschreibung
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
Stichworte
Versionen (1)
- 27.05.20 27.05.20 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
27. Mai 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility Heart Failure (HF) NCT02127307
Eligibility Heart Failure (HF) NCT02127307
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Heart Failure (HF) NCT02127307
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
C0686905 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0025102 (UMLS CUI [2,2])
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])
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])
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])
C0686905 (UMLS CUI [1,2])
C1148433 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])