ID

24626

Description

Follow-up Study to Previous CARE Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00479024

Link

https://clinicaltrials.gov/show/NCT00479024

Keywords

Versions (1)
  1. 8/9/17 8/9/17 -
Uploaded on

August 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Moderate to Severe Chronic Kidney Disease NCT00479024

English

Eligibility Moderate to Severe Chronic Kidney Disease NCT00479024

1 forms  
Criteria
Description

Criteria

• screening egfr between 20 and 59 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
baseline scr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
Description

Hydration Therapy | Blood specimen Available | Administration Contrast Media

Data type

boolean

Alias
UMLS CUI [1]
C1881074
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C0470187
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0009924
at least one post dose blood sample available
Description

Blood specimen Post-dose Quantity Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0470187
received randomized contrast agent
Description

Contrast Media Randomized Received

Data type

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C1514756
underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by pci was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
Description

Angiocardiography Quantity | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0002971
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1532338
provides written informed consent and is willing to comply with protocol requirements;
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
was included in the patient list provided by bracco;
Description

Study Subject Participation Status | List Company Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0745732
UMLS CUI [2,2]
C0683757
UMLS CUI [2,3]
C0205369
at least 1 year has passed since the patient's participation ended in the original care trial, as determined from the list provided by bracco
Description

Study Subject Participation Status | Clinical Trial Previous

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• screening egfr outside the range of 20 and 59 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
unstable kidney disease or requiring dialysis upon enrollment
Description

Kidney Disease Unstable | Kidney Disease Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0011946
prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
Description

Blood draw Post-dose | Event Clinical Affecting Measurement of renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0439568
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2711919
did not receive randomized contrast agent per care protocol
Description

Contrast Media Randomized Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0332268
did not undergo a cardiac angiography procedure per care protocol
Description

Angiocardiography Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0002971
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Moderate to Severe Chronic Kidney Disease NCT00479024

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Estimated Glomerular Filtration Rate
Item
• screening egfr between 20 and 59 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Hydration Therapy | Blood specimen Available | Administration Contrast Media
Item
baseline scr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
boolean
C1881074 (UMLS CUI [1])
C0178913 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C1533734 (UMLS CUI [3,1])
C0009924 (UMLS CUI [3,2])
Blood specimen Post-dose Quantity Available
Item
at least one post dose blood sample available
boolean
C0178913 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Contrast Media Randomized Received
Item
received randomized contrast agent
boolean
C0009924 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Angiocardiography Quantity | Percutaneous Coronary Intervention
Item
underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by pci was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
boolean
C0002971 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
provides written informed consent and is willing to comply with protocol requirements;
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Study Subject Participation Status | List Company Specified
Item
was included in the patient list provided by bracco;
boolean
C2348568 (UMLS CUI [1])
C0745732 (UMLS CUI [2,1])
C0683757 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial Previous
Item
at least 1 year has passed since the patient's participation ended in the original care trial, as determined from the list provided by bracco
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
• screening egfr outside the range of 20 and 59 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Kidney Disease Unstable | Kidney Disease Requirement Dialysis
Item
unstable kidney disease or requiring dialysis upon enrollment
boolean
C0022658 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Blood draw Post-dose | Event Clinical Affecting Measurement of renal function
Item
prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
boolean
C0005834 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0441471 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2711919 (UMLS CUI [2,4])
Contrast Media Randomized Lacking
Item
did not receive randomized contrast agent per care protocol
boolean
C0009924 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Angiocardiography Lacking
Item
did not undergo a cardiac angiography procedure per care protocol
boolean
C0002971 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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