ID

21162

Description

An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00813202

Link

https://clinicaltrials.gov/show/NCT00813202

Keywords

  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Heart Decompensation NCT00813202

Eligibility Heart Decompensation NCT00813202

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
systolic blood pressure> 90 mmhg
Description

Systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
the subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)
Description

Dyspnea

Data type

boolean

Alias
UMLS CUI [1]
C0013404
onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration
Description

Onset of acute decompensate heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C1399214
UMLS CUI [1,2]
C0574845
acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)
Description

Reason for decompensation

Data type

boolean

Alias
UMLS CUI [1,1]
C1399214
UMLS CUI [1,2]
C0392360
the patients must have at least two of manifestations that related with this acute onset.
Description

Count of manifestation

Data type

boolean

Alias
UMLS CUI [1,1]
C1280464
UMLS CUI [1,2]
C0750480
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with systolic blood pressure =90 mmhg
Description

Systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug
Description

Intravenous vasoactive drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C1522726
patients who had known or suspected acute coronary syndrome (myocardial infarction with or without increased st segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug
Description

Acute coronary syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents
Description

Cardiac shock, uncorrected hypovolemia, sodium depletion

Data type

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0546884
UMLS CUI [3]
C0020625
patients with such extremely emergent and unstable clinical conditions that not tolerant to swan-ganz catheter or temporal baseline evaluation
Description

Severe medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
patients with obvious cardiac valvular stenosis (subjects treated by valve-replacement can be included), hypertrophic, restrictive, or obstructive myocardial disease, primary pulmonary hypertension, or complex congenital heart disease.
Description

Cardiac comorbiditiy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0009488

Similar models

Eligibility Heart Decompensation NCT00813202

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systolic blood pressure
Item
systolic blood pressure> 90 mmhg
boolean
C0871470 (UMLS CUI [1])
Dyspnea
Item
the subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)
boolean
C0013404 (UMLS CUI [1])
Onset of acute decompensate heart failure
Item
onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration
boolean
C1399214 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Reason for decompensation
Item
acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)
boolean
C1399214 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Count of manifestation
Item
the patients must have at least two of manifestations that related with this acute onset.
boolean
C1280464 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systolic blood pressure
Item
patients with systolic blood pressure =90 mmhg
boolean
C0871470 (UMLS CUI [1])
Intravenous vasoactive drugs
Item
patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug
boolean
C0597639 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Acute coronary syndrome
Item
patients who had known or suspected acute coronary syndrome (myocardial infarction with or without increased st segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug
boolean
C0948089 (UMLS CUI [1])
Cardiac shock, uncorrected hypovolemia, sodium depletion
Item
patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents
boolean
C0036980 (UMLS CUI [1])
C0546884 (UMLS CUI [2])
C0020625 (UMLS CUI [3])
Severe medical condition
Item
patients with such extremely emergent and unstable clinical conditions that not tolerant to swan-ganz catheter or temporal baseline evaluation
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiac comorbiditiy
Item
patients with obvious cardiac valvular stenosis (subjects treated by valve-replacement can be included), hypertrophic, restrictive, or obstructive myocardial disease, primary pulmonary hypertension, or complex congenital heart disease.
boolean
C0018787 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial