0 Ratings
ID

22439

Description

Wireless, Intermittent Monitoring of Right Heart Pressures in HF; ODM derived from: https://clinicaltrials.gov/show/NCT01162707

Link

https://clinicaltrials.gov/show/NCT01162707

Keywords

Versions (1)
  1. 6/4/17 6/4/17 -
Uploaded on

June 4, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility NYHA Class III Heart Failure NCT01162707

    English

    Eligibility NYHA Class III Heart Failure NCT01162707

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. subject is male or female, at least 18 years of age
    Description

    gender, age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    2. subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
    Description

    childbearing age, pregnancy test, contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1960468
    UMLS CUI [1,2]
    C0032976
    UMLS CUI [1,3]
    C0700589
    3. subject has a diagnosis of new york heart association (nyha) class iii hf at screening and at baseline.
    Description

    congestive heart failure, nyha class

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C1275491
    4. subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    5. subject has life expectancy of 1-2 years.
    Description

    life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. subject has unstable medical condition or impairment other than a medical condition associated with hf which would significantly increase the subject's morbidity or mortality risk.
    Description

    unstable medical condition, morbidity, mortality

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [1,3]
    C0220880
    UMLS CUI [1,4]
    C0681679
    2. subject is unable to tolerate a right heart catheterization.
    Description

    right heart catheterization, toleration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0189896
    UMLS CUI [1,2]
    C0680282
    3. subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
    Description

    planned heart transplantation or cardiac surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301732
    UMLS CUI [1,2]
    C0018823
    UMLS CUI [2,1]
    C1301732
    UMLS CUI [2,2]
    C0018821
    4. subject has permanent indwelling central venous catheter.
    Description

    permanent indwelling central venous catheter

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205355
    UMLS CUI [1,2]
    C2049627
    5. subject has history of myocardial infarction (mi), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
    Description

    medical history myocardial infarction, unstable angina, stroke, transient ischemic attack, or intractable arrhythmia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0027051
    UMLS CUI [3]
    C0002965
    UMLS CUI [4]
    C0038454
    UMLS CUI [5]
    C0007787
    UMLS CUI [6,1]
    C0003811
    UMLS CUI [6,2]
    C0205269
    6. subject has history of congenital heart disease or prosthetic valve on right side.
    Description

    congenital heart disease, prosthetic valve on right side

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0152021
    UMLS CUI [2,1]
    C0336548
    UMLS CUI [2,2]
    C0225808
    7. subject has unstable hypertension.
    Description

    unstable hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0443343
    UMLS CUI [1,2]
    C0020538
    8. subject has a known coagulability disease state.
    Description

    coagulability disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    9. subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
    Description

    hypersensitivity clopidogrel, aspirin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0070166
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0004057
    10. subject has active lung infection or acute pulmonary decompensation.
    Description

    lung infection, pulmonary decompensation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0876973
    UMLS CUI [2]
    C0748117
    11. subject has elevated white blood cell count and signs of infection are evident.
    Description

    elevated white blood cell count and signs of infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750426
    UMLS CUI [1,2]
    C0513965
    12. subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
    Description

    chronic renal insufficiency, serum creatinine, dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0403447
    UMLS CUI [1,2]
    C0201976
    UMLS CUI [1,3]
    C0011946
    13. subject who is pregnant or lactating or might become pregnant during the duration of the study.
    Description

    pregnancy, breast feeding, childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C3831118
    14. subject who is participating in another therapeutic interventional trial.
    Description

    study subject participation status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    15. subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
    Description

    compliance behavior, comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C0009488
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    Similar models

    Eligibility NYHA Class III Heart Failure NCT01162707

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender, age
    Item
    1. subject is male or female, at least 18 years of age
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    childbearing age, pregnancy test, contraceptive methods
    Item
    2. subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
    boolean
    C1960468 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    congestive heart failure, nyha class
    Item
    3. subject has a diagnosis of new york heart association (nyha) class iii hf at screening and at baseline.
    boolean
    C0018802 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    informed consent
    Item
    4. subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    life expectancy
    Item
    5. subject has life expectancy of 1-2 years.
    boolean
    C0023671 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    unstable medical condition, morbidity, mortality
    Item
    1. subject has unstable medical condition or impairment other than a medical condition associated with hf which would significantly increase the subject's morbidity or mortality risk.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C0220880 (UMLS CUI [1,3])
    C0681679 (UMLS CUI [1,4])
    right heart catheterization, toleration
    Item
    2. subject is unable to tolerate a right heart catheterization.
    boolean
    C0189896 (UMLS CUI [1,1])
    C0680282 (UMLS CUI [1,2])
    planned heart transplantation or cardiac surgery
    Item
    3. subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
    boolean
    C1301732 (UMLS CUI [1,1])
    C0018823 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [2,1])
    C0018821 (UMLS CUI [2,2])
    permanent indwelling central venous catheter
    Item
    4. subject has permanent indwelling central venous catheter.
    boolean
    C0205355 (UMLS CUI [1,1])
    C2049627 (UMLS CUI [1,2])
    medical history myocardial infarction, unstable angina, stroke, transient ischemic attack, or intractable arrhythmia
    Item
    5. subject has history of myocardial infarction (mi), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
    boolean
    C0262926 (UMLS CUI [1])
    C0027051 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0038454 (UMLS CUI [4])
    C0007787 (UMLS CUI [5])
    C0003811 (UMLS CUI [6,1])
    C0205269 (UMLS CUI [6,2])
    congenital heart disease, prosthetic valve on right side
    Item
    6. subject has history of congenital heart disease or prosthetic valve on right side.
    boolean
    C0152021 (UMLS CUI [1])
    C0336548 (UMLS CUI [2,1])
    C0225808 (UMLS CUI [2,2])
    unstable hypertension
    Item
    7. subject has unstable hypertension.
    boolean
    C0443343 (UMLS CUI [1,1])
    C0020538 (UMLS CUI [1,2])
    coagulability disease
    Item
    8. subject has a known coagulability disease state.
    boolean
    C0005779 (UMLS CUI [1])
    hypersensitivity clopidogrel, aspirin
    Item
    9. subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0070166 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0004057 (UMLS CUI [2,2])
    lung infection, pulmonary decompensation
    Item
    10. subject has active lung infection or acute pulmonary decompensation.
    boolean
    C0876973 (UMLS CUI [1])
    C0748117 (UMLS CUI [2])
    elevated white blood cell count and signs of infection
    Item
    11. subject has elevated white blood cell count and signs of infection are evident.
    boolean
    C0750426 (UMLS CUI [1,1])
    C0513965 (UMLS CUI [1,2])
    chronic renal insufficiency, serum creatinine, dialysis
    Item
    12. subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
    boolean
    C0403447 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    C0011946 (UMLS CUI [1,3])
    pregnancy, breast feeding, childbearing potential
    Item
    13. subject who is pregnant or lactating or might become pregnant during the duration of the study.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
    study subject participation status
    Item
    14. subject who is participating in another therapeutic interventional trial.
    boolean
    C2348568 (UMLS CUI [1])
    compliance behavior, comorbidity
    Item
    15. subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
    boolean
    C1321605 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
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