0 Ratings
ID

17597

Description

Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG); ODM derived from: https://clinicaltrials.gov/show/NCT00093886

Link

https://clinicaltrials.gov/show/NCT00093886

Keywords

Versions (1)
  1. 9/25/16 9/25/16 -
Uploaded on

September 25, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hypertension NCT00093886

    English

    Eligibility Hypertension NCT00093886

    1 forms  
    Criteria
    Description

    Criteria

    provide written informed consent before initiation of any study related procedures.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    be at least 18 years of age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery
    Description

    Coronary Artery Bypass Surgery | Coronary Artery Bypass, Off-Pump | Minimally invasive direct coronary artery bypass | Heart valve replacement | Repair of heart valve

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010055
    UMLS CUI [2]
    C1449706
    UMLS CUI [3]
    C1690495
    UMLS CUI [4]
    C0190173
    UMLS CUI [5]
    C0190112
    prerandomization exclusion criteria:
    Description

    Exclusion Criteria Randomization Before

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C0332152
    women of child-bearing potential (unless they have a negative pregnancy test)
    Description

    Childbearing Potential Pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    recent cerebrovascular accident (within 3 months before randomization)
    Description

    Cerebrovascular accident Recent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C0332185
    known intolerance to calcium channel blockers
    Description

    intolerance to Calcium Channel Blockers

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706
    UMLS CUI [1,2]
    C0006684
    known or suspected hypersensitivity to nitroglycerin
    Description

    Hypersensitivity Nitroglycerin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0017887
    allergy to soybean oil or egg lecithin (components of the lipid vehicle)
    Description

    Hypersensitivity Soybean Oil | Hypersensitivity egg lecithin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0037732
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0772274
    pre-existing permanent ventricular pacing
    Description

    Ventricular pacing Permanent Pre-existing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0429115
    UMLS CUI [1,2]
    C0205355
    UMLS CUI [1,3]
    C2347662
    any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
    Description

    Disease Study Subject Participation Status At risk | condition Study Subject Participation Status At risk

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C1444641
    participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
    Description

    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    UMLS CUI [3]
    C2346570
    postrandomization inclusion criteria:
    Description

    Inclusion criteria Randomization Post

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C0687676
    determined to be hypertensive perioperatively as determined by the investigator
    Description

    Hypertensive perioperative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0857121
    UMLS CUI [1,2]
    C1518988
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    Similar models

    Eligibility Hypertension NCT00093886

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Informed Consent
    Item
    provide written informed consent before initiation of any study related procedures.
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    be at least 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Coronary Artery Bypass Surgery | Coronary Artery Bypass, Off-Pump | Minimally invasive direct coronary artery bypass | Heart valve replacement | Repair of heart valve
    Item
    be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery
    boolean
    C0010055 (UMLS CUI [1])
    C1449706 (UMLS CUI [2])
    C1690495 (UMLS CUI [3])
    C0190173 (UMLS CUI [4])
    C0190112 (UMLS CUI [5])
    Exclusion Criteria Randomization Before
    Item
    prerandomization exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Childbearing Potential Pregnancy test negative
    Item
    women of child-bearing potential (unless they have a negative pregnancy test)
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    Cerebrovascular accident Recent
    Item
    recent cerebrovascular accident (within 3 months before randomization)
    boolean
    C0038454 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    intolerance to Calcium Channel Blockers
    Item
    known intolerance to calcium channel blockers
    boolean
    C1744706 (UMLS CUI [1,1])
    C0006684 (UMLS CUI [1,2])
    Hypersensitivity Nitroglycerin
    Item
    known or suspected hypersensitivity to nitroglycerin
    boolean
    C0020517 (UMLS CUI [1,1])
    C0017887 (UMLS CUI [1,2])
    Hypersensitivity Soybean Oil | Hypersensitivity egg lecithin
    Item
    allergy to soybean oil or egg lecithin (components of the lipid vehicle)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0037732 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0772274 (UMLS CUI [2,2])
    Ventricular pacing Permanent Pre-existing
    Item
    pre-existing permanent ventricular pacing
    boolean
    C0429115 (UMLS CUI [1,1])
    C0205355 (UMLS CUI [1,2])
    C2347662 (UMLS CUI [1,3])
    Disease Study Subject Participation Status At risk | condition Study Subject Participation Status At risk
    Item
    any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
    boolean
    C0012634 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
    Item
    participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C2346570 (UMLS CUI [3])
    Inclusion criteria Randomization Post
    Item
    postrandomization inclusion criteria:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C0687676 (UMLS CUI [1,3])
    Hypertensive perioperative
    Item
    determined to be hypertensive perioperatively as determined by the investigator
    boolean
    C0857121 (UMLS CUI [1,1])
    C1518988 (UMLS CUI [1,2])
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