ID

27510

Beskrivning

Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG); ODM derived from: https://clinicaltrials.gov/show/NCT00451256

Länk

https://clinicaltrials.gov/show/NCT00451256

Nyckelord

Versioner (1)
  1. 11/19/17 11/19/17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

November 19, 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00451256

Engelsk

Eligibility Cardiovascular Disease NCT00451256

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
subject is a suitable candidate for aortocoronary bypass (cabg) procedure. subjects undergoing cabg procedure without the use of coronary artery bypass (off pump) are preferred. however, subjects requiring coronary artery bypass will not be excluded from the study
Beskrivning

Patient Suitable Coronary Artery Bypass Surgery | Preference Coronary Artery Bypass, Off-Pump

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0010055
UMLS CUI [2,1]
C0558295
UMLS CUI [2,2]
C1449706
female subjects of childbearing potential must have a documented negative serum pregnancy test within 2 days before the cabg procedure
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Beskrivning

Compliance behavior Follow-up visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0589121
subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee of the respective clinical site.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject will have valve replacement or repair during cabg procedure
Beskrivning

Replacement; valve | Repair of heart valve

Datatyp

boolean

Alias
UMLS CUI [1]
C1410969
UMLS CUI [2]
C0190112
subject has a poor quality donor vessel (poor or turbulent flow, varicose)
Beskrivning

Donor Vessel Quality Poor | Vessel flow Poor | Vessel Turbulent blood flow | Vessel Varicose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0332306
UMLS CUI [1,4]
C2700379
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C0806140
UMLS CUI [2,3]
C2700379
UMLS CUI [3,1]
C0005847
UMLS CUI [3,2]
C1827505
UMLS CUI [4,1]
C0005847
UMLS CUI [4,2]
C0439652
subject has a known left ventricular ejection fraction of <35%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
subject has had a percutaneous coronary intervention (pci) for coronary artery disease treatment 30 days prior to cabg
Beskrivning

Percutaneous Coronary Intervention Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1956346
subject has a pci planned during the 30 days immediately following the cabg procedure
Beskrivning

Percutaneous Coronary Intervention Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
subject has chronic atrial fibrillation
Beskrivning

Chronic atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0694539
subject has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media which cannot be adequately pre-medicated
Beskrivning

Aspirin allergy | Heparin allergy | Hypersensitivity Ticlopidine | Hypersensitivity clopidogrel | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication Ticlopidine | Medical contraindication clopidogrel | Contrast media allergy Premedication Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0070166
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0004057
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0019134
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0040207
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0070166
UMLS CUI [9,1]
C0570562
UMLS CUI [9,2]
C0033045
UMLS CUI [9,3]
C1272705
subject has chronic renal insufficiency (i.e., serum creatinine >180 mmol/l) or co-morbid illness which precludes follow-up angiography
Beskrivning

Chronic Kidney Insufficiency | Creatinine measurement, serum | Comorbidity Excludes Follow-up angiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1522577
UMLS CUI [3,4]
C0002978
subject has history of a stroke or transient ischemic attack within the prior 6 months
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
subject has an active peptic ulcer or has had clinically significant upper or lower gi bleeding within the prior 6 months
Beskrivning

Peptic Ulcer | Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
UMLS CUI [3]
C0024050
subject has a history of a bleeding diathesis or coagulopathy or will refuse blood transfusions
Beskrivning

Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Refuse

Datatyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0005841
UMLS CUI [3,2]
C1705116
subject has a non-cardiac illness imposing substantial operative mortality
Beskrivning

Illness Relevance Mortality Operative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0026566
UMLS CUI [1,4]
C1882154
subject has a concurrent medical condition resulting in a life expectancy of less than 3 years
Beskrivning

Comorbidity | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
subject is currently participating in an investigational drug or another device study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Cardiovascular Disease NCT00451256

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Patient Suitable Coronary Artery Bypass Surgery | Preference Coronary Artery Bypass, Off-Pump
Item
subject is a suitable candidate for aortocoronary bypass (cabg) procedure. subjects undergoing cabg procedure without the use of coronary artery bypass (off pump) are preferred. however, subjects requiring coronary artery bypass will not be excluded from the study
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0558295 (UMLS CUI [2,1])
C1449706 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
female subjects of childbearing potential must have a documented negative serum pregnancy test within 2 days before the cabg procedure
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Compliance behavior Follow-up visit
Item
subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
boolean
C1321605 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Informed Consent
Item
subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee of the respective clinical site.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Replacement; valve | Repair of heart valve
Item
subject will have valve replacement or repair during cabg procedure
boolean
C1410969 (UMLS CUI [1])
C0190112 (UMLS CUI [2])
Donor Vessel Quality Poor | Vessel flow Poor | Vessel Turbulent blood flow | Vessel Varicose
Item
subject has a poor quality donor vessel (poor or turbulent flow, varicose)
boolean
C0013018 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0332306 (UMLS CUI [1,3])
C2700379 (UMLS CUI [1,4])
C0005847 (UMLS CUI [2,1])
C0806140 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
C0005847 (UMLS CUI [3,1])
C1827505 (UMLS CUI [3,2])
C0005847 (UMLS CUI [4,1])
C0439652 (UMLS CUI [4,2])
Left ventricular ejection fraction
Item
subject has a known left ventricular ejection fraction of <35%
boolean
C0428772 (UMLS CUI [1])
Percutaneous Coronary Intervention Coronary Artery Disease
Item
subject has had a percutaneous coronary intervention (pci) for coronary artery disease treatment 30 days prior to cabg
boolean
C1532338 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Planned
Item
subject has a pci planned during the 30 days immediately following the cabg procedure
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Chronic atrial fibrillation
Item
subject has chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Aspirin allergy | Heparin allergy | Hypersensitivity Ticlopidine | Hypersensitivity clopidogrel | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication Ticlopidine | Medical contraindication clopidogrel | Contrast media allergy Premedication Unsuccessful
Item
subject has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media which cannot be adequately pre-medicated
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0070166 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0004057 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0019134 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0040207 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0070166 (UMLS CUI [8,2])
C0570562 (UMLS CUI [9,1])
C0033045 (UMLS CUI [9,2])
C1272705 (UMLS CUI [9,3])
Chronic Kidney Insufficiency | Creatinine measurement, serum | Comorbidity Excludes Follow-up angiography
Item
subject has chronic renal insufficiency (i.e., serum creatinine >180 mmol/l) or co-morbid illness which precludes follow-up angiography
boolean
C0403447 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1522577 (UMLS CUI [3,3])
C0002978 (UMLS CUI [3,4])
Cerebrovascular accident | Transient Ischemic Attack
Item
subject has history of a stroke or transient ischemic attack within the prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Peptic Ulcer | Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage
Item
subject has an active peptic ulcer or has had clinically significant upper or lower gi bleeding within the prior 6 months
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
C0024050 (UMLS CUI [3])
Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Refuse
Item
subject has a history of a bleeding diathesis or coagulopathy or will refuse blood transfusions
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0005841 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Illness Relevance Mortality Operative
Item
subject has a non-cardiac illness imposing substantial operative mortality
boolean
C0221423 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0026566 (UMLS CUI [1,3])
C1882154 (UMLS CUI [1,4])
Comorbidity | Life Expectancy
Item
subject has a concurrent medical condition resulting in a life expectancy of less than 3 years
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subject is currently participating in an investigational drug or another device study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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