ID

20484

Description

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety; ODM derived from: https://clinicaltrials.gov/show/NCT00415961

Link

https://clinicaltrials.gov/show/NCT00415961

Keywords

Versions (1)
  1. 2/25/17 2/25/17 -
Uploaded on

February 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00415961

English

Eligibility Coronary Disease NCT00415961

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria
Description

Inclusion criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
eligible for percutaneous coronary intervention (pci)
Description

eligibility Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0680253
UMLS CUI [1,2]
C1532338
documented stable or unstable angina pectoris (class i, ii, iii or iv), documented ischemia, or documented silent ischemia
Description

Stable angina New York Heart Association Classification | Unstable Angina New York Heart Association Classification | Ischemia | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0340288
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0022116
UMLS CUI [4]
C0340291
documented lvef ≥25% within the last 6 weeks.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
eligible for coronary artery bypass graft surgery (cabg)
Description

eligibility Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0680253
UMLS CUI [1,2]
C0010055
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria: -
Description

Exclusion Criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
known sensitivity to paclitaxel or polymeric matrices.
Description

Paclitaxel allergy | Hypersensitivity Matrix Polymeric

Data type

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C4050026
UMLS CUI [2,3]
C0032521
planned treatment with any other pci device in the target vessel(s).
Description

Percutaneous Coronary Intervention Device Target vessel Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0025080
UMLS CUI [1,3]
C0449618
UMLS CUI [1,4]
C1301732
mi within 72 hours prior to the index procedure
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
patient is in cardiogenic shock
Description

Shock, Cardiogenic

Data type

boolean

Alias
UMLS CUI [1]
C0036980
cerebrovascular accident (cva) within the past 6 months
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/l)
Description

Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0201976
contraindication to asa or to ticlopidine
Description

Medical contraindication Aspirin | Medical contraindication Ticlopidine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0040207
thrombocytopenia
Description

Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0040034
active gi bleeding within past three months
Description

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
known allergy to cobalt chromium
Description

Hypersensitivity Cobalt-Chromium

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008576
any prior true anaphylactic reaction to contrast agents
Description

anaphylaxis Contrast Media

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0009924
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Similar models

Eligibility Coronary Disease NCT00415961

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
eligibility Percutaneous Coronary Intervention
Item
eligible for percutaneous coronary intervention (pci)
boolean
C0680253 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Stable angina New York Heart Association Classification | Unstable Angina New York Heart Association Classification | Ischemia | Silent myocardial ischemia
Item
documented stable or unstable angina pectoris (class i, ii, iii or iv), documented ischemia, or documented silent ischemia
boolean
C0340288 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0022116 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Left ventricular ejection fraction
Item
documented lvef ≥25% within the last 6 weeks.
boolean
C0428772 (UMLS CUI [1])
eligibility Coronary Artery Bypass Surgery
Item
eligible for coronary artery bypass graft surgery (cabg)
boolean
C0680253 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
general exclusion criteria: -
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Paclitaxel allergy | Hypersensitivity Matrix Polymeric
Item
known sensitivity to paclitaxel or polymeric matrices.
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C4050026 (UMLS CUI [2,2])
C0032521 (UMLS CUI [2,3])
Percutaneous Coronary Intervention Device Target vessel Planned
Item
planned treatment with any other pci device in the target vessel(s).
boolean
C1532338 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Myocardial Infarction
Item
mi within 72 hours prior to the index procedure
boolean
C0027051 (UMLS CUI [1])
Shock, Cardiogenic
Item
patient is in cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Cerebrovascular accident
Item
cerebrovascular accident (cva) within the past 6 months
boolean
C0038454 (UMLS CUI [1])
Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum
Item
acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/l)
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Medical contraindication Aspirin | Medical contraindication Ticlopidine
Item
contraindication to asa or to ticlopidine
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0040207 (UMLS CUI [2,2])
Thrombocytopenia
Item
thrombocytopenia
boolean
C0040034 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
active gi bleeding within past three months
boolean
C0017181 (UMLS CUI [1])
Hypersensitivity Cobalt-Chromium
Item
known allergy to cobalt chromium
boolean
C0020517 (UMLS CUI [1,1])
C0008576 (UMLS CUI [1,2])
anaphylaxis Contrast Media
Item
any prior true anaphylactic reaction to contrast agents
boolean
C0002792 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
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