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ID

14985

Description

Complexity of Bifurcation Lesions Treated With Optimal Strategies; ODM derived from: https://clinicaltrials.gov/show/NCT02284750

Link

https://clinicaltrials.gov/show/NCT02284750

Keywords

  1. 5/10/16 5/10/16 -
Uploaded on

May 10, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Coronary Artery Disease NCT02284750

    Eligibility Coronary Artery Disease NCT02284750

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    provision of informed consent prior to any study specific procedures;
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    men and women 18 years and older;.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    established indication to pci according to the guidelines of american heart association and american college of cardiology;
    Description

    Indication Percutaneous Coronary Intervention | American Heart Association Guidelines

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C1532338 (Percutaneous Coronary Intervention)
    SNOMED
    415070008
    UMLS CUI [2,1]
    C0002458 (American Heart Association)
    UMLS CUI [2,2]
    C0162791 (Guidelines)
    native coronary lesion suitable for drug-eluting stent placement;
    Description

    Coronary Vessel Lesion Native | Amenable Drug-eluting coronary stent placement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3272304 (Coronary Vessel Lesion)
    UMLS CUI [1,2]
    C0302891 (Native (qualifier value))
    SNOMED
    263818007
    UMLS CUI [2,1]
    C3900053 (Amenable)
    UMLS CUI [2,2]
    C2609296 (Drug-eluting coronary stent placement)
    true bifurcation lesions (medina 0,1,1/1,1,1 /1,0,1);
    Description

    Bifurcation lesion of coronary artery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1299363 (Bifurcation lesion of coronary artery)
    SNOMED
    371894001
    reference vessel diameter in side branch ≥2.5mm by visual estimation.
    Description

    Mean Vessel Diameter | Visual estimation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3898449 (Mean Vessel Diameter)
    UMLS CUI [2]
    C0444684 (Visual estimation)
    SNOMED
    258083009
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    pregnancy and breast feeding mother;
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    co-morbidity with an estimated life expectancy of < 50 % at 12 months;
    Description

    Comorbidity | Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    UMLS CUI [2]
    C0023671 (Life Expectancy)
    scheduled major surgery in the next 12 months;
    Description

    Major surgery Scheduled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0679637 (major surgery)
    UMLS CUI [1,2]
    C0205539 (Scheduled - procedure status)
    SNOMED
    416151008
    LOINC
    LA22866-0
    inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
    Description

    Compliance behavior Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [3,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [3,2]
    C2346570 (Investigational Medical Device)
    known allergy against ticagrelor, or against clopidogrel, or aspirin history of major hemorrhage (intracranial, gastrointestinal, etc.);
    Description

    Hypersensitivity Ticagrelor | Hypersensitivity clopidogrel | History of chronic use of aspirin Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1999375 (ticagrelor)
    SNOMED
    698805004
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0070166 (clopidogrel)
    SNOMED
    108979001
    UMLS CUI [3,1]
    C2054132 (History of chronic use of aspirin)
    UMLS CUI [3,2]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI [3,3]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    UMLS CUI [4]
    C0151699 (Intracranial Hemorrhage)
    SNOMED
    1386000
    UMLS CUI [5]
    C0017181 (Gastrointestinal Hemorrhage)
    SNOMED
    74474003
    LOINC
    LP209002-7
    chronic total occlusion lesion in either lad, or lcx or rca not re-canalized;
    Description

    chronic total occlusion Anterior descending branch of left coronary artery | chronic total occlusion Structure of circumflex branch of left coronary artery | chronic total occlusion Entire right coronary artery | recanalized

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3275069 (Chronic Total Occlusion Vessel)
    UMLS CUI [1,2]
    C0226032 (Anterior descending branch of left coronary artery)
    SNOMED
    59438005
    UMLS CUI [2,1]
    C3275069 (Chronic Total Occlusion Vessel)
    UMLS CUI [2,2]
    C0226037 (Structure of circumflex branch of left coronary artery)
    SNOMED
    57396003
    UMLS CUI [3,1]
    C3275069 (Chronic Total Occlusion Vessel)
    UMLS CUI [3,2]
    C0226042 (Entire right coronary artery)
    SNOMED
    362037006
    UMLS CUI [4]
    C0333328 (recanalized)
    severe calcification needing rotational atherectomy;
    Description

    Calcification Severe Needs Rotational Atherectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0175895 (Calcified (qualifier))
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [1,3]
    C0027552 (Needs)
    SNOMED
    410525008
    UMLS CUI [1,4]
    C0162655 (Rotational Atherectomy)
    SNOMED
    65659003
    patient with stemi (within 24-hour from the onset of chest pain to admission).
    Description

    ST segment elevation myocardial infarction | Chest Pain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1536220 (ST segment elevation myocardial infarction)
    UMLS CUI [2]
    C0008031 (Chest Pain)
    SNOMED
    29857009

    Similar models

    Eligibility Coronary Artery Disease NCT02284750

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    provision of informed consent prior to any study specific procedures;
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    men and women 18 years and older;.
    boolean
    C0001779 (UMLS CUI [1])
    Indication Percutaneous Coronary Intervention | American Heart Association Guidelines
    Item
    established indication to pci according to the guidelines of american heart association and american college of cardiology;
    boolean
    C3146298 (UMLS CUI [1,1])
    C1532338 (UMLS CUI [1,2])
    C0002458 (UMLS CUI [2,1])
    C0162791 (UMLS CUI [2,2])
    Coronary Vessel Lesion Native | Amenable Drug-eluting coronary stent placement
    Item
    native coronary lesion suitable for drug-eluting stent placement;
    boolean
    C3272304 (UMLS CUI [1,1])
    C0302891 (UMLS CUI [1,2])
    C3900053 (UMLS CUI [2,1])
    C2609296 (UMLS CUI [2,2])
    Bifurcation lesion of coronary artery
    Item
    true bifurcation lesions (medina 0,1,1/1,1,1 /1,0,1);
    boolean
    C1299363 (UMLS CUI [1])
    Mean Vessel Diameter | Visual estimation
    Item
    reference vessel diameter in side branch ≥2.5mm by visual estimation.
    boolean
    C3898449 (UMLS CUI [1])
    C0444684 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding
    Item
    pregnancy and breast feeding mother;
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Comorbidity | Life Expectancy
    Item
    co-morbidity with an estimated life expectancy of < 50 % at 12 months;
    boolean
    C0009488 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    Major surgery Scheduled
    Item
    scheduled major surgery in the next 12 months;
    boolean
    C0679637 (UMLS CUI [1,1])
    C0205539 (UMLS CUI [1,2])
    Compliance behavior Limited
    Item
    inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Study Subject Participation Status | Therapeutic procedure Investigational New Drugs | Therapeutic procedure Investigational Medical Device
    Item
    previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
    boolean
    C2348568 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C2346570 (UMLS CUI [3,2])
    Hypersensitivity Ticagrelor | Hypersensitivity clopidogrel | History of chronic use of aspirin Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage
    Item
    known allergy against ticagrelor, or against clopidogrel, or aspirin history of major hemorrhage (intracranial, gastrointestinal, etc.);
    boolean
    C0020517 (UMLS CUI [1,1])
    C1999375 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0070166 (UMLS CUI [2,2])
    C2054132 (UMLS CUI [3,1])
    C0019080 (UMLS CUI [3,2])
    C0205164 (UMLS CUI [3,3])
    C0151699 (UMLS CUI [4])
    C0017181 (UMLS CUI [5])
    chronic total occlusion Anterior descending branch of left coronary artery | chronic total occlusion Structure of circumflex branch of left coronary artery | chronic total occlusion Entire right coronary artery | recanalized
    Item
    chronic total occlusion lesion in either lad, or lcx or rca not re-canalized;
    boolean
    C3275069 (UMLS CUI [1,1])
    C0226032 (UMLS CUI [1,2])
    C3275069 (UMLS CUI [2,1])
    C0226037 (UMLS CUI [2,2])
    C3275069 (UMLS CUI [3,1])
    C0226042 (UMLS CUI [3,2])
    C0333328 (UMLS CUI [4])
    Calcification Severe Needs Rotational Atherectomy
    Item
    severe calcification needing rotational atherectomy;
    boolean
    C0175895 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0027552 (UMLS CUI [1,3])
    C0162655 (UMLS CUI [1,4])
    ST segment elevation myocardial infarction | Chest Pain
    Item
    patient with stemi (within 24-hour from the onset of chest pain to admission).
    boolean
    C1536220 (UMLS CUI [1])
    C0008031 (UMLS CUI [2])

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