0 Avaliações
ID

15920

Descrição

POISE Trial: Perioperative Ischemic Evaluation Study; ODM derived from: https://clinicaltrials.gov/show/NCT00182039

Link

https://clinicaltrials.gov/show/NCT00182039

Palavras-chave

Versões (2)
  1. 05/06/2016 05/06/2016 -
  2. 18/06/2016 18/06/2016 -
Transferido a

18 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Cardiovascular Diseases NCT00182039

    Inglês

    Eligibility Cardiovascular Diseases NCT00182039

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients undergoing noncardiac surgery
    Descrição

    noncardiac surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [1,2]
    C1522601 (Cardiac - anatomy qualifier)
    UMLS CUI [1,3]
    C1518422 (Negation)
    LOINC
    LA21291-2
    ≥ 45 years of age; either sex.
    Descrição

    age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    have an expected length of stay ≥ 24 hours
    Descrição

    in-patient duration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023303 (Length of Stay)
    fulfill any one of the following 6 criteria:
    Descrição

    ID.4

    Tipo de dados

    boolean

    coronary artery disease;
    Descrição

    coronary artery disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1956346 (Coronary Artery Disease)
    SNOMED
    53741008
    peripheral vascular disease;
    Descrição

    peripheral vascular disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085096 (Peripheral Vascular Diseases)
    SNOMED
    400047006
    history of stroke due to atherothrombotic disease;
    Descrição

    history of stroke

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4039739 (History of cerebellar stroke)
    SNOMED
    690051000119100
    hospitalization for congestive heart failure within 3 years of randomization;
    Descrição

    congestive heart failure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    undergoing major vascular surgery; or
    Descrição

    major vascular surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042381 (Vascular Surgical Procedures)
    SNOMED
    30904006
    any 3 of the following 7 criteria: scheduled for high risk surgery (i.e. intraperitoneal or intrathoracic); emergency/urgent surgery; any history of congestive heart failure; history of a transient ischemic attack (tia); diabetes and currently on an oral hypoglycemic agent or insulin therapy; preoperative serum creatinine > 175 µmol/l (> 2.0 mg/dl); or age > 70 years.
    Descrição

    informed consent; comorbidities

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2216322 (emergency surgical procedure)
    UMLS CUI [2,1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [2,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [3,1]
    C0007787 (Transient Ischemic Attack)
    SNOMED
    266257000
    UMLS CUI [3,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [4,1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [4,2]
    C0020616 (Hypoglycemic Agents)
    SNOMED
    312064005
    LOINC
    LP33333-3
    UMLS CUI [4,3]
    C0557978 (Insulin regime)
    SNOMED
    225302006
    UMLS CUI [5,1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [5,2]
    C0445204 (Preoperative)
    SNOMED
    262068006
    LOINC
    LP91296-1
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    contraindication to metoprolol including any of the following: significant bradycardia (heart rate < 50 beats per minute); second or third degree heart block without a pacemaker; asthma that has been active within the last decade; and history of chronic obstructive pulmonary disease (copd) with bronchospasm on pulmonary function tests.
    Descrição

    contraindication to metoprolol

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0428977 (Bradycardia)
    SNOMED
    48867003
    LOINC
    LA17394-0
    UMLS CUI [2]
    C0264906 (Second degree atrioventricular block)
    SNOMED
    195042002
    UMLS CUI [3]
    C0151517 (Complete atrioventricular block)
    SNOMED
    27885002
    LOINC
    LA17089-6
    UMLS CUI [4]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [5]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days
    Descrição

    beta-blocker usage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    prior adverse reaction to a beta-blocker
    Descrição

    hypersensitivity to beta-blocker

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    coronary artery bypass graft (cabg) surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the cabg surgery
    Descrição

    cabg

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0010055 (Coronary Artery Bypass Surgery)
    SNOMED
    67166004
    LOINC
    LA14276-2
    UMLS CUI [1,2]
    C0151744 (Myocardial Ischemia)
    SNOMED
    414545008
    UMLS CUI [1,3]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    patients undergoing low risk surgical procedures (potential examples include transurethral procedures [transurethral prostatectomies (turps), stone baskets, etc.], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc.], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc.] )
    Descrição

    low risk surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [1,2]
    C3538919 (Low risk (qualifier value))
    SNOMED
    723505004
    concurrent use of verapamil
    Descrição

    concurrent use of verapamil

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009429 (Combined Modality Therapy)
    SNOMED
    229554006
    UMLS CUI [1,2]
    C0042523 (verapamil)
    SNOMED
    47898004
    prior enrollment in this trial
    Descrição

    prior enrollment in this trial

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1516879 (Enrollment)
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
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    Similar models

    Eligibility Cardiovascular Diseases NCT00182039

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    noncardiac surgery
    Item
    patients undergoing noncardiac surgery
    boolean
    C0543467 (UMLS CUI [1,1])
    C1522601 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    age
    Item
    ≥ 45 years of age; either sex.
    boolean
    C0001779 (UMLS CUI [1])
    in-patient duration
    Item
    have an expected length of stay ≥ 24 hours
    boolean
    C0023303 (UMLS CUI [1])
    ID.4
    Item
    fulfill any one of the following 6 criteria:
    boolean
    coronary artery disease
    Item
    coronary artery disease;
    boolean
    C1956346 (UMLS CUI [1])
    peripheral vascular disease
    Item
    peripheral vascular disease;
    boolean
    C0085096 (UMLS CUI [1])
    history of stroke
    Item
    history of stroke due to atherothrombotic disease;
    boolean
    C4039739 (UMLS CUI [1])
    congestive heart failure
    Item
    hospitalization for congestive heart failure within 3 years of randomization;
    boolean
    C0019993 (UMLS CUI [1,1])
    C0018802 (UMLS CUI [1,2])
    major vascular surgery
    Item
    undergoing major vascular surgery; or
    boolean
    C0042381 (UMLS CUI [1])
    informed consent; comorbidities
    Item
    any 3 of the following 7 criteria: scheduled for high risk surgery (i.e. intraperitoneal or intrathoracic); emergency/urgent surgery; any history of congestive heart failure; history of a transient ischemic attack (tia); diabetes and currently on an oral hypoglycemic agent or insulin therapy; preoperative serum creatinine > 175 µmol/l (> 2.0 mg/dl); or age > 70 years.
    boolean
    C2216322 (UMLS CUI [1])
    C0018802 (UMLS CUI [2,1])
    C0262926 (UMLS CUI [2,2])
    C0007787 (UMLS CUI [3,1])
    C0262926 (UMLS CUI [3,2])
    C0011849 (UMLS CUI [4,1])
    C0020616 (UMLS CUI [4,2])
    C0557978 (UMLS CUI [4,3])
    C0201976 (UMLS CUI [5,1])
    C0445204 (UMLS CUI [5,2])
    Item Group
    C0680251 (UMLS CUI)
    contraindication to metoprolol
    Item
    contraindication to metoprolol including any of the following: significant bradycardia (heart rate < 50 beats per minute); second or third degree heart block without a pacemaker; asthma that has been active within the last decade; and history of chronic obstructive pulmonary disease (copd) with bronchospasm on pulmonary function tests.
    boolean
    C0428977 (UMLS CUI [1])
    C0264906 (UMLS CUI [2])
    C0151517 (UMLS CUI [3])
    C0004096 (UMLS CUI [4])
    C0024117 (UMLS CUI [5])
    beta-blocker usage
    Item
    clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days
    boolean
    C0001645 (UMLS CUI [1])
    hypersensitivity to beta-blocker
    Item
    prior adverse reaction to a beta-blocker
    boolean
    C0020517 (UMLS CUI [1,1])
    C0001645 (UMLS CUI [1,2])
    cabg
    Item
    coronary artery bypass graft (cabg) surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the cabg surgery
    boolean
    C0010055 (UMLS CUI [1,1])
    C0151744 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    low risk surgery
    Item
    patients undergoing low risk surgical procedures (potential examples include transurethral procedures [transurethral prostatectomies (turps), stone baskets, etc.], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc.], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc.] )
    boolean
    C0543467 (UMLS CUI [1,1])
    C3538919 (UMLS CUI [1,2])
    concurrent use of verapamil
    Item
    concurrent use of verapamil
    boolean
    C0009429 (UMLS CUI [1,1])
    C0042523 (UMLS CUI [1,2])
    prior enrollment in this trial
    Item
    prior enrollment in this trial
    boolean
    C1516879 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
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