ID

20440

Description

Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study); ODM derived from: https://clinicaltrials.gov/show/NCT00423280

Link

https://clinicaltrials.gov/show/NCT00423280

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00423280

English

Eligibility Coronary Artery Disease NCT00423280

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (cabg)
Description

Multi vessel coronary artery disease | Coronary Artery Bypass Surgery Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C1299432
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0205539
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
female subject who is pregnant, lactating or planning pregnancy during course of study
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
prior clinical diagnosis of heart failure requiring diuretic therapy with evidence of severe left ventricular dysfunction
Description

Heart failure Requirement Diuretic therapy | Left Ventricular Dysfunction Severe Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0948575
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C3887511
recent acute coronary event (<4 weeks)
Description

Event Coronary

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1522318
emergency cabg
Description

Emergency CABG

Data type

boolean

Alias
UMLS CUI [1]
C1532296
newly diagnosed diabetes mellitus (<1 month)
Description

Diabetes Mellitus Newly Diagnosed

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1518321
body weight >130kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
impaired renal function (creatinine >180umol/l)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
elevated liver function tests (alt >50umol/l or ast >2x normal)
Description

Increased liver function tests | Alanine aminotransferase measurement | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0877359
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0151904
pacemakers, icds or metallic implants not compatible with mri scanning
Description

Artificial cardiac pacemaker Consistent with Magnetic Resonance Imaging | Implantable defibrillator Consistent with Magnetic Resonance Imaging | Implants Metallic Consistent with Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C2986473
UMLS CUI [3,3]
C0332290
UMLS CUI [3,4]
C0024485
subjects receiving experimental medications or participating in another study
Description

Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
terminally ill subjects
Description

Subject Terminally Ill

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0039552
known hypersensitivity to 6r-bh4
Description

Hypersensitivity Sapropterin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0048897
concomitant treatment with methotrexate, levodopa, pde-3 or pde-5 inhibitors
Description

Methotrexate | Levodopa | Phosphodiesterase 3 Inhibitors | Phosphodiesterase 5 inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0023570
UMLS CUI [3]
C2267032
UMLS CUI [4]
C1318700
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Similar models

Eligibility Coronary Artery Disease NCT00423280

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multi vessel coronary artery disease | Coronary Artery Bypass Surgery Scheduled
Item
multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (cabg)
boolean
C1299432 (UMLS CUI [1])
C0010055 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female subject who is pregnant, lactating or planning pregnancy during course of study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Heart failure Requirement Diuretic therapy | Left Ventricular Dysfunction Severe Evidence
Item
prior clinical diagnosis of heart failure requiring diuretic therapy with evidence of severe left ventricular dysfunction
boolean
C0018801 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0948575 (UMLS CUI [1,3])
C0242698 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
Event Coronary
Item
recent acute coronary event (<4 weeks)
boolean
C0441471 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
Emergency CABG
Item
emergency cabg
boolean
C1532296 (UMLS CUI [1])
Diabetes Mellitus Newly Diagnosed
Item
newly diagnosed diabetes mellitus (<1 month)
boolean
C0011849 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Body Weight
Item
body weight >130kg
boolean
C0005910 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function (creatinine >180umol/l)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Increased liver function tests | Alanine aminotransferase measurement | Aspartate aminotransferase increased
Item
elevated liver function tests (alt >50umol/l or ast >2x normal)
boolean
C0877359 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Artificial cardiac pacemaker Consistent with Magnetic Resonance Imaging | Implantable defibrillator Consistent with Magnetic Resonance Imaging | Implants Metallic Consistent with Magnetic Resonance Imaging
Item
pacemakers, icds or metallic implants not compatible with mri scanning
boolean
C0030163 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0162589 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0021102 (UMLS CUI [3,1])
C2986473 (UMLS CUI [3,2])
C0332290 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
Investigational New Drugs | Study Subject Participation Status
Item
subjects receiving experimental medications or participating in another study
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Subject Terminally Ill
Item
terminally ill subjects
boolean
C0681850 (UMLS CUI [1,1])
C0039552 (UMLS CUI [1,2])
Hypersensitivity Sapropterin
Item
known hypersensitivity to 6r-bh4
boolean
C0020517 (UMLS CUI [1,1])
C0048897 (UMLS CUI [1,2])
Methotrexate | Levodopa | Phosphodiesterase 3 Inhibitors | Phosphodiesterase 5 inhibitor
Item
concomitant treatment with methotrexate, levodopa, pde-3 or pde-5 inhibitors
boolean
C0025677 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C2267032 (UMLS CUI [3])
C1318700 (UMLS CUI [4])
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