ID

16828

Description

The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation; ODM derived from: https://clinicaltrials.gov/show/NCT00060840

Link

https://clinicaltrials.gov/show/NCT00060840

Keywords

Versions (1)
  1. 8/9/16 8/9/16 -
Uploaded on

August 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00060840

English

Eligibility Congestive Heart Failure NCT00060840

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
scheduled to undergo their first lvad implantation, (or at least 6 months after explanation of a previous lvad).
Description

Implantation of left ventricular assist device First Planned | Explantation Left ventricular assist device

Data type

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0561946
UMLS CUI [2,2]
C0181598
has a pulmonary vascular resistance of at least 2.5 wood units (200 dynes/sec.) in the 30 days prior to lvad placement.
Description

Pulmonary Vascular Resistance Before Implantation of left ventricular assist device

Data type

boolean

Alias
UMLS CUI [1,1]
C0456261
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0397130
greater than 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed irb approved informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
Description

Congestive heart failure Due to Giant cell myocarditis | Congestive heart failure Due to Restrictive cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0264856
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0007196
elective biventricular assist device (bivad) surgery, or current support with a temporary bivad.
Description

Elective Surgical Procedures Biventricular assist device | Support Biventricular assist device Temporary

Data type

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C0179322
UMLS CUI [2,1]
C1521721
UMLS CUI [2,2]
C0179322
UMLS CUI [2,3]
C0205374
lvad procedure expected to be done without cardiopulmonary bypass.
Description

Left ventricular assist device procedure | Cardiopulmonary Bypass

Data type

boolean

Alias
UMLS CUI [1,1]
C0181598
UMLS CUI [1,2]
C0184661
UMLS CUI [2]
C0007202
pregnancy (a negative pregnancy test must be documented prior to enrollment).
Description

Pregnancy Negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0427780
received nitric oxide by inhalation therapy within the past 24 hours.
Description

administration of inhaled nitric oxide

Data type

boolean

Alias
UMLS CUI [1]
C1135443
investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
Description

Investigational New Drugs Changing Pulmonary Vascular Resistance | Investigational New Drugs Changing Systemic Vascular Resistance

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0456261
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1258192
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Similar models

Eligibility Congestive Heart Failure NCT00060840

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantation of left ventricular assist device First Planned | Explantation Left ventricular assist device
Item
scheduled to undergo their first lvad implantation, (or at least 6 months after explanation of a previous lvad).
boolean
C0397130 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0561946 (UMLS CUI [2,1])
C0181598 (UMLS CUI [2,2])
Pulmonary Vascular Resistance Before Implantation of left ventricular assist device
Item
has a pulmonary vascular resistance of at least 2.5 wood units (200 dynes/sec.) in the 30 days prior to lvad placement.
boolean
C0456261 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0397130 (UMLS CUI [1,3])
Age
Item
greater than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
signed irb approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congestive heart failure Due to Giant cell myocarditis | Congestive heart failure Due to Restrictive cardiomyopathy
Item
patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
boolean
C0018802 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0264856 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0007196 (UMLS CUI [2,3])
Elective Surgical Procedures Biventricular assist device | Support Biventricular assist device Temporary
Item
elective biventricular assist device (bivad) surgery, or current support with a temporary bivad.
boolean
C0206058 (UMLS CUI [1,1])
C0179322 (UMLS CUI [1,2])
C1521721 (UMLS CUI [2,1])
C0179322 (UMLS CUI [2,2])
C0205374 (UMLS CUI [2,3])
Left ventricular assist device procedure | Cardiopulmonary Bypass
Item
lvad procedure expected to be done without cardiopulmonary bypass.
boolean
C0181598 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0007202 (UMLS CUI [2])
Pregnancy Negative pregnancy test
Item
pregnancy (a negative pregnancy test must be documented prior to enrollment).
boolean
C0032961 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
administration of inhaled nitric oxide
Item
received nitric oxide by inhalation therapy within the past 24 hours.
boolean
C1135443 (UMLS CUI [1])
Investigational New Drugs Changing Pulmonary Vascular Resistance | Investigational New Drugs Changing Systemic Vascular Resistance
Item
investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
boolean
C0013230 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0456261 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1258192 (UMLS CUI [2,3])
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