ID

16266

Descrição

Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00281073

Link

https://clinicaltrials.gov/show/NCT00281073

Palavras-chave

  1. 08/07/2016 08/07/2016 -
Transferido a

8 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Atrial Fibrillation NCT00281073

    Eligibility Atrial Fibrillation NCT00281073

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    inclusion criteria for the phase i component
    Descrição

    inclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    1. patients with spontaneous af
    Descrição

    spontaneous af

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0235480
    2. patients with or without structural heart disease.
    Descrição

    structural heart disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1290384
    3. men or women aged 18 years or older.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    4. patients undergoing an invasive catheterization procedure including right heart catheterization.
    Descrição

    invasive catheterization procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018795
    5. patients who give an informed consent for participation in the study.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
    Descrição

    intracardiac thrombi

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0876998
    7. patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.
    Descrição

    trans-esophageal echocardiogram

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0206054
    inclusion criteria for the phase ii component
    Descrição

    inclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    1. patients with spontaneous af
    Descrição

    spontaneous af

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0235480
    2. patients with or without structural heart disease.
    Descrição

    structural heart disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1290384
    3. men or women aged 18 years or older.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    4. patients undergoing an invasive catheterization procedure including right heart catheterization.
    Descrição

    invasive catheterization procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018795
    5. patients who give an informed consent for participation in the study.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
    Descrição

    intracardiac thrombi

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0876998
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    exclusion criteria for the phase ii component
    Descrição

    exclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    1. patients anticoagulated for > 7 days.
    Descrição

    Anticoagulation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0449867
    2. patients who have had a cardioembolic event within the last 1-month.
    Descrição

    cardioembolic event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1531624
    3. patients requiring urgent cardioversion due to hemodynamic instability.
    Descrição

    cardioversion due to hemodynamic instability

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013778
    UMLS CUI [2]
    C0948268
    4. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
    Descrição

    Technical feasibility

    Tipo de dados

    boolean

    5. patients with contraindications for warfarin.
    Descrição

    contraindications for warfarin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278473
    6. women of child bearing potential, in whom pregnancy cannot be excluded.
    Descrição

    women of child bearing potential

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0425965
    7. patients who need anticoagulation withdrawn due to an elective procedure
    Descrição

    anticoagulation

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0449867
    8. patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.
    Descrição

    medical condition or social circumstance

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0037431
    exclusion criteria for the phase i component
    Descrição

    exclusion criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    1. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
    Descrição

    Technical feasibility

    Tipo de dados

    boolean

    2. women of child bearing potential, in whom pregnancy cannot be excluded.
    Descrição

    women of child bearing potential

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0425965
    3. patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
    Descrição

    medical condition or social circumstance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0037431

    Similar models

    Eligibility Atrial Fibrillation NCT00281073

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    inclusion criteria
    Item
    inclusion criteria for the phase i component
    boolean
    C1512693 (UMLS CUI [1])
    spontaneous af
    Item
    1. patients with spontaneous af
    boolean
    C0235480 (UMLS CUI [1])
    structural heart disease
    Item
    2. patients with or without structural heart disease.
    boolean
    C1290384 (UMLS CUI [1])
    Age
    Item
    3. men or women aged 18 years or older.
    boolean
    C0001779 (UMLS CUI [1])
    invasive catheterization procedure
    Item
    4. patients undergoing an invasive catheterization procedure including right heart catheterization.
    boolean
    C0018795 (UMLS CUI [1])
    informed consent
    Item
    5. patients who give an informed consent for participation in the study.
    boolean
    C0021430 (UMLS CUI [1])
    intracardiac thrombi
    Item
    6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
    boolean
    C0876998 (UMLS CUI [1])
    trans-esophageal echocardiogram
    Item
    7. patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.
    boolean
    C0206054 (UMLS CUI [1])
    inclusion criteria
    Item
    inclusion criteria for the phase ii component
    boolean
    C1512693 (UMLS CUI [1])
    spontaneous af
    Item
    1. patients with spontaneous af
    boolean
    C0235480 (UMLS CUI [1])
    structural heart disease
    Item
    2. patients with or without structural heart disease.
    boolean
    C1290384 (UMLS CUI [1])
    Age
    Item
    3. men or women aged 18 years or older.
    boolean
    C0001779 (UMLS CUI [1])
    invasive catheterization procedure
    Item
    4. patients undergoing an invasive catheterization procedure including right heart catheterization.
    boolean
    C0018795 (UMLS CUI [1])
    informed consent
    Item
    5. patients who give an informed consent for participation in the study.
    boolean
    C0021430 (UMLS CUI [1])
    intracardiac thrombi
    Item
    6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
    boolean
    C0876998 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    exclusion criteria
    Item
    exclusion criteria for the phase ii component
    boolean
    C0680251 (UMLS CUI [1])
    Anticoagulation
    Item
    1. patients anticoagulated for > 7 days.
    boolean
    C0449867 (UMLS CUI [1])
    cardioembolic event
    Item
    2. patients who have had a cardioembolic event within the last 1-month.
    boolean
    C1531624 (UMLS CUI [1])
    cardioversion due to hemodynamic instability
    Item
    3. patients requiring urgent cardioversion due to hemodynamic instability.
    boolean
    C0013778 (UMLS CUI [1])
    C0948268 (UMLS CUI [2])
    Technical feasibility
    Item
    4. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
    boolean
    contraindications for warfarin
    Item
    5. patients with contraindications for warfarin.
    boolean
    C1278473 (UMLS CUI [1])
    women of child bearing potential
    Item
    6. women of child bearing potential, in whom pregnancy cannot be excluded.
    text
    C0425965 (UMLS CUI [1])
    anticoagulation
    Item
    7. patients who need anticoagulation withdrawn due to an elective procedure
    text
    C0449867 (UMLS CUI [1])
    medical condition or social circumstance
    Item
    8. patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.
    text
    C0009488 (UMLS CUI [1])
    C0037431 (UMLS CUI [2])
    exclusion criteria
    Item
    exclusion criteria for the phase i component
    boolean
    C0680251 (UMLS CUI [1])
    Technical feasibility
    Item
    1. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
    boolean
    women of child bearing potential
    Item
    2. women of child bearing potential, in whom pregnancy cannot be excluded.
    boolean
    C0425965 (UMLS CUI [1])
    medical condition or social circumstance
    Item
    3. patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
    boolean
    C0009488 (UMLS CUI [1])
    C0037431 (UMLS CUI [2])

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