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ID

12465

Beschrijving

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions. https://clinicaltrials.gov/ct2/show/NCT01241903

Link

https://clinicaltrials.gov/ct2/show/NCT01241903

Trefwoorden

Versies (2)
  1. 28-07-15 28-07-15 -
  2. 21-11-15 21-11-15 -
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21 november 2015

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Rosuvastatin Acute Coronary Syndrome NCT01241903

    Engels

    Eligibility Critera

    1 Formulieren  
    1. StudyEvent: ODM
      1. Eligibility Critera
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Subjects must be between 18 and 80 years old.
    Beschrijving

    Subjects must be between 18 and 80 years old.

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Subjects must be willing and able to give informed consent
    Beschrijving

    Subjects must be willing and able to give informed consent

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0021430 (Informed Consent)
    A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
    Beschrijving

    A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Subjects must have symptoms of acute coronary syndrome
    Beschrijving

    Subjects must have symptoms of acute coronary syndrome

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948089 (Acute Coronary Syndrome)
    SNOMED
    394659003
    Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
    Beschrijving

    Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0360714 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
    SNOMED
    372912004
    Exclusion criteria
    Beschrijving

    Exclusion criteria

    Use of Crestor in the past 30 days
    Beschrijving

    Use of Crestor in the past 30 days

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C1098080 (Crestor)
    GFR (estimated) <30 ml/min
    Beschrijving

    GFR (estimated) <30 ml/min

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0017654 (Glomerular Filtration Rate)
    SNOMED
    80274001
    Hemodialysis
    Beschrijving

    Hemodialysis

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0019004 (Hemodialysis)
    SNOMED
    302497006
    LOINC
    LA9975-9
    History of liver failure
    Beschrijving

    History of liver failure

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0085605 (Liver Failure)
    SNOMED
    59927004
    Unexplained liver function abnormalities
    Beschrijving

    Unexplained liver function abnormalities

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0086565 (Liver Dysfunction)
    SNOMED
    75183008
    Current or planned use of cyclosporine
    Beschrijving

    Current or planned use of cyclosporine

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0010592 (cyclosporine)
    SNOMED
    387467008
    Current or planned use of gemfibrozil
    Beschrijving

    Current or planned use of gemfibrozil

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0017245 (gemfibrozil)
    SNOMED
    35282000
    Sepsis
    Beschrijving

    Sepsis

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0243026 (Sepsis)
    SNOMED
    91302008
    LOINC
    LA10591-8
    Hypotension
    Beschrijving

    Hypotension

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0020649 (Hypotension)
    SNOMED
    45007003
    LOINC
    MTHU020790
    Dehydration
    Beschrijving

    Dehydration

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0011175 (Dehydration)
    SNOMED
    34095006
    LOINC
    MTHU020843
    Trauma
    Beschrijving

    Trauma

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0332677 (major injury)
    Recent (within the last 2 weeks) or planned (in the next month) major surgery
    Beschrijving

    Recent (within the last 2 weeks) or planned (in the next month) major surgery

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0679637 (major surgery)
    HIV/AIDS with current of planned use of HIV protease inhibitors
    Beschrijving

    HIV/AIDS with current of planned use of HIV protease inhibitors

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0001175 (Acquired Immunodeficiency Syndrome)
    SNOMED
    62479008
    LOINC
    LA10430-9
    Metabolic abnormality
    Beschrijving

    Metabolic abnormality

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0280606 (metabolic abnormality assessment)
    electrolyte abnormality
    Beschrijving

    electrolyte abnormality

    Datatype

    boolean

    Alias
    UMLS CUI-1
    C0151613 (Electrolytes abnormal)
    SNOMED
    166686006
    Terug naar het begin van de pagina

    Similar models

    Eligibility Critera

    1 Formulieren
    1. StudyEvent: ODM
      1. Eligibility Critera
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Inclusion Criteria
    Age
    Item
    Subjects must be between 18 and 80 years old.
    boolean
    C0001779 (UMLS CUI-1)
    Informed consent
    Item
    Subjects must be willing and able to give informed consent
    boolean
    C0021430 (UMLS CUI-1)
    Contraception
    Item
    A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
    boolean
    C0700589 (UMLS CUI-1)
    Acute coronary syndrome
    Item
    Subjects must have symptoms of acute coronary syndrome
    boolean
    C0948089 (UMLS CUI [1])
    Statins
    Item
    Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
    boolean
    C0360714 (UMLS CUI-1)
    Item Group
    Exclusion criteria
    Rosuvastatin
    Item
    Use of Crestor in the past 30 days
    boolean
    C1098080 (UMLS CUI-1)
    GFR
    Item
    GFR (estimated) <30 ml/min
    boolean
    C0017654 (UMLS CUI-1)
    Hemodialysis
    Item
    Hemodialysis
    boolean
    C0019004 (UMLS CUI-1)
    Liver failure
    Item
    History of liver failure
    boolean
    C0085605 (UMLS CUI-1)
    Liver dysfunction
    Item
    Unexplained liver function abnormalities
    boolean
    C0086565 (UMLS CUI-1)
    Cyclosporine
    Item
    Current or planned use of cyclosporine
    boolean
    C0010592 (UMLS CUI-1)
    Gemfibrozil
    Item
    Current or planned use of gemfibrozil
    boolean
    C0017245 (UMLS CUI-1)
    Sepsis
    Item
    Sepsis
    boolean
    C0243026 (UMLS CUI-1)
    Hypotension
    Item
    Hypotension
    boolean
    C0020649 (UMLS CUI-1)
    Dehydration
    Item
    Dehydration
    boolean
    C0011175 (UMLS CUI-1)
    Major injury
    Item
    Trauma
    boolean
    C0332677 (UMLS CUI-1)
    Major surgery
    Item
    Recent (within the last 2 weeks) or planned (in the next month) major surgery
    boolean
    C0679637 (UMLS CUI-1)
    AIDS
    Item
    HIV/AIDS with current of planned use of HIV protease inhibitors
    boolean
    C0001175 (UMLS CUI-1)
    Metabolic abnormality
    Item
    Metabolic abnormality
    boolean
    C0280606 (UMLS CUI-1)
    electrolyte abnormality
    Item
    electrolyte abnormality
    boolean
    C0151613 (UMLS CUI-1)
    Terug naar het begin van de pagina 

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