ID

16869

Description

Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA; ODM derived from: https://clinicaltrials.gov/show/NCT00653042

Link

https://clinicaltrials.gov/show/NCT00653042

Keywords

Versions (1)
  1. 8/11/16 8/11/16 -
Uploaded on

August 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Bypass Surgery NCT00653042

English

Eligibility Coronary Artery Bypass Surgery NCT00653042

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha class ii-iv chf
Description

Congestive heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C1275491
presenting for cabg with or without mitral valve repair or replacement procedure
Description

Coronary Artery Bypass Surgery | Mitral Valve: Repair | Replacement of mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0869755
UMLS CUI [3]
C0026268
planned utilization of cpb
Description

Cardiopulmonary Bypass Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0007202
UMLS CUI [1,2]
C1301732
documentation of left ventricular ejection fraction (lvef) less than or equal to 40% measured by nuclear scan, echocardiogram (echo), or ventriculogram, within 90 days prior to surgery.
Description

Left ventricular ejection fraction | Radionuclide Imaging | Echocardiogram | Ventriculogram | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0034606
UMLS CUI [3]
C2243117
UMLS CUI [4]
C0394239
UMLS CUI [5]
C0543467
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
planned aortic valve replacement or repair
Description

Replacement of aortic valve Planned | Aortic Valve: Repair Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0003506
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0869750
UMLS CUI [2,2]
C1301732
ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis)
Description

Dialysis | dialysis chronic | Hemodialysis | Peritoneal Dialysis, Continuous Ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0743165
UMLS CUI [3]
C0019004
UMLS CUI [4]
C0031140
restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
Description

Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade

Data type

boolean

Alias
UMLS CUI [1]
C0007196
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0031048
UMLS CUI [4]
C0007177
documented or suspected low cardiac filling pressures
Description

Intracardiac pressure low

Data type

boolean

Alias
UMLS CUI [1,1]
C0428876
UMLS CUI [1,2]
C0205251
any known congenital heart disease
Description

Congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0152021
known allergic reaction or sensitivity to nesiritide or excipients
Description

Allergic Reaction Nesiritide | Allergic Reaction Nesiritide Excipient | Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0054015
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0054015
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0054015
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0054015
UMLS CUI [4,3]
C0015237
females of childbearing potential with a positive serum pregnancy test, and nursing mothers
Description

Childbearing Potential Serum pregnancy test positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430063
UMLS CUI [2]
C0006147
treated with investigational drug or device within last 30 days
Description

Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
documented fever (>101 degrees f) within 72 hours of surgery
Description

Fever Degrees fahrenheit | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0456628
UMLS CUI [2]
C0543467
wbc > 15,000/mm3 within 72 hours of surgery
Description

White Blood Cell Count procedure | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0543467
documented bacterial/fungal/viral infection requiring administration of iv antibiotics within 7 days before surgery
Description

Bacterial Infections Requirement Intravenous antibiotic therapy | Mycoses Requirement Intravenous antibiotic therapy | Virus Diseases Requirement Intravenous antibiotic therapy | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0559680
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0559680
UMLS CUI [4]
C0543467
pulmonary disease (copd, asthma or other condition) that required inpatient medical or surgical treatment within 60 days before surgery. treatment exclusion criteria (obtained after anesthesia induction and before chest incision prior to the start of study drug) include: mean pulmonary artery pressure consistently < or equal to 15mmhg
Description

Lung diseases | Chronic Obstructive Airway Disease | Asthma | Hospitalization Patient need for | Operative Surgical Procedures Patient need for | Induction of anesthesia | Thoracotomy | Investigational New Drugs | Pulmonary artery mean pressure

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0004096
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0686904
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0686904
UMLS CUI [6]
C0853212
UMLS CUI [7]
C0039991
UMLS CUI [8]
C0013230
UMLS CUI [9]
C0428645
central venous pressure consistently < 6 mmhg
Description

Measurement of central venous pressure

Data type

boolean

Alias
UMLS CUI [1]
C0199666
and systolic blood pressure consistently < 90 mmhg. use of open-label nesiritide within 48 hours of study drug administration.
Description

Systolic Pressure | Nesiritide | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0054015
UMLS CUI [3]
C0013230
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Similar models

Eligibility Coronary Artery Bypass Surgery NCT00653042

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure | New York Heart Association Classification
Item
nyha class ii-iv chf
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Coronary Artery Bypass Surgery | Mitral Valve: Repair | Replacement of mitral valve
Item
presenting for cabg with or without mitral valve repair or replacement procedure
boolean
C0010055 (UMLS CUI [1])
C0869755 (UMLS CUI [2])
C0026268 (UMLS CUI [3])
Cardiopulmonary Bypass Planned
Item
planned utilization of cpb
boolean
C0007202 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Left ventricular ejection fraction | Radionuclide Imaging | Echocardiogram | Ventriculogram | Operative Surgical Procedures
Item
documentation of left ventricular ejection fraction (lvef) less than or equal to 40% measured by nuclear scan, echocardiogram (echo), or ventriculogram, within 90 days prior to surgery.
boolean
C0428772 (UMLS CUI [1])
C0034606 (UMLS CUI [2])
C2243117 (UMLS CUI [3])
C0394239 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Replacement of aortic valve Planned | Aortic Valve: Repair Planned
Item
planned aortic valve replacement or repair
boolean
C0003506 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0869750 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Dialysis | dialysis chronic | Hemodialysis | Peritoneal Dialysis, Continuous Ambulatory
Item
ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis)
boolean
C0011946 (UMLS CUI [1])
C0743165 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
C0031140 (UMLS CUI [4])
Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade
Item
restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
boolean
C0007196 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0031048 (UMLS CUI [3])
C0007177 (UMLS CUI [4])
Intracardiac pressure low
Item
documented or suspected low cardiac filling pressures
boolean
C0428876 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Congenital heart disease
Item
any known congenital heart disease
boolean
C0152021 (UMLS CUI [1])
Allergic Reaction Nesiritide | Allergic Reaction Nesiritide Excipient | Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Excipient
Item
known allergic reaction or sensitivity to nesiritide or excipients
boolean
C1527304 (UMLS CUI [1,1])
C0054015 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0054015 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0054015 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0054015 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Childbearing Potential Serum pregnancy test positive | Breast Feeding
Item
females of childbearing potential with a positive serum pregnancy test, and nursing mothers
boolean
C3831118 (UMLS CUI [1,1])
C0430063 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Investigational Medical Device
Item
treated with investigational drug or device within last 30 days
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Fever Degrees fahrenheit | Operative Surgical Procedures
Item
documented fever (>101 degrees f) within 72 hours of surgery
boolean
C0015967 (UMLS CUI [1,1])
C0456628 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
White Blood Cell Count procedure | Operative Surgical Procedures
Item
wbc > 15,000/mm3 within 72 hours of surgery
boolean
C0023508 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Bacterial Infections Requirement Intravenous antibiotic therapy | Mycoses Requirement Intravenous antibiotic therapy | Virus Diseases Requirement Intravenous antibiotic therapy | Operative Surgical Procedures
Item
documented bacterial/fungal/viral infection requiring administration of iv antibiotics within 7 days before surgery
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
C0026946 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0559680 (UMLS CUI [2,3])
C0042769 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0559680 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4])
Lung diseases | Chronic Obstructive Airway Disease | Asthma | Hospitalization Patient need for | Operative Surgical Procedures Patient need for | Induction of anesthesia | Thoracotomy | Investigational New Drugs | Pulmonary artery mean pressure
Item
pulmonary disease (copd, asthma or other condition) that required inpatient medical or surgical treatment within 60 days before surgery. treatment exclusion criteria (obtained after anesthesia induction and before chest incision prior to the start of study drug) include: mean pulmonary artery pressure consistently < or equal to 15mmhg
boolean
C0024115 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
C0853212 (UMLS CUI [6])
C0039991 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
C0428645 (UMLS CUI [9])
Measurement of central venous pressure
Item
central venous pressure consistently < 6 mmhg
boolean
C0199666 (UMLS CUI [1])
Systolic Pressure | Nesiritide | Investigational New Drugs
Item
and systolic blood pressure consistently < 90 mmhg. use of open-label nesiritide within 48 hours of study drug administration.
boolean
C0871470 (UMLS CUI [1])
C0054015 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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