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ID

40860

Beschrijving

A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI; ODM derived from: https://clinicaltrials.gov/show/NCT02015832

Link

https://clinicaltrials.gov/show/NCT02015832

Trefwoorden

Versies (1)
  1. 27-05-20 27-05-20 -
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See clinicaltrials.gov

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27 mei 2020

DOI

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Creative Commons BY 4.0
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    Eligibility Heart Diseases NCT02015832

    Engels

    Eligibility Heart Diseases NCT02015832

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    at least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. these are left descending coronary artery (lad) and or side branch, proximal circumflex coronary artery (lcx) and or side branch, right descending coronary artery (rca) and or side branch which are supplying viable myocardium without left main involvement. patients with ostial lad or ostial cx medina 0,0,1 or medina 0,1,0 may be enrolled
    Beschrijving

    Stenosis Quantity Angiography | Lesion de novo | Stenosis Diameter Percentage | Left Anterior Descending artery | Left circumflex artery | Right coronary artery

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1261287
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0002978
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1515568
    UMLS CUI [3,1]
    C1261287
    UMLS CUI [3,2]
    C1301886
    UMLS CUI [3,3]
    C0439165
    UMLS CUI [4]
    C0226032
    UMLS CUI [5]
    C1305727
    UMLS CUI [6]
    C0226042
    patients with hypoplastic rca with absence of descending posterior and presence of a lesion in the lad and cx territories may be included in the trial as a 3 vessel disease equivalent
    Beschrijving

    Right coronary artery Hypoplastic | Posterior descending artery Lesion Absent | Left anterior descending artery Lesion | Circumflex artery Lesion | Triple vessel disease Equivalent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0226042
    UMLS CUI [1,2]
    C0543481
    UMLS CUI [2,1]
    C0500492
    UMLS CUI [2,2]
    C0221198
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3,1]
    C1321506
    UMLS CUI [3,2]
    C0221198
    UMLS CUI [4,1]
    C1305727
    UMLS CUI [4,2]
    C0221198
    UMLS CUI [5,1]
    C0856738
    UMLS CUI [5,2]
    C0205163
    vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram
    Beschrijving

    Vessel Size Diameter | Vessel Angiography

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005847
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C1301886
    UMLS CUI [2,1]
    C0005847
    UMLS CUI [2,2]
    C0002978
    patients with
    Beschrijving

    Patients Have

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C3539897
    1. stable (canadian cardiovascular society class 1, 2, 3 or 4) angina pectoris
    Beschrijving

    Stable angina CCS Class

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0340288
    UMLS CUI [1,2]
    C1879987
    2. or unstable (braunwald class) angina pectoris and ischemia
    Beschrijving

    Unstable Angina Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0002965
    UMLS CUI [1,2]
    C0008902
    3. or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography
    Beschrijving

    Atypical chest pain | Myocardial Ischemia Asymptomatic | Stress test treadmill | Radionuclide Imaging | Stress Echocardiography

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0262384
    UMLS CUI [2,1]
    C0151744
    UMLS CUI [2,2]
    C0231221
    UMLS CUI [3]
    C3878122
    UMLS CUI [4]
    C0034606
    UMLS CUI [5,1]
    C0038435
    UMLS CUI [5,2]
    C0013516
    all anatomical syntax scores are eligible for initial screening with the syntax score ii
    Beschrijving

    Coronary Artery Disease Score

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1956346
    UMLS CUI [1,2]
    C0449820
    patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee of the respective clinical site
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    signed heart team decision form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria
    Beschrijving

    Cardiologist Approval | Surgeon Approval | Eligibility Criteria Fulfill

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0175906
    UMLS CUI [1,2]
    C0205540
    UMLS CUI [2,1]
    C0582175
    UMLS CUI [2,2]
    C0205540
    UMLS CUI [3,1]
    C1516637
    UMLS CUI [3,2]
    C1550543
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    under the age of 21 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    known pregnancy at time of enrolment. female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. female who is breastfeeding at time of enrolment
    Beschrijving

    Pregnancy | Childbearing Potential Contraceptive methods Absent | Breast Feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3]
    C0006147
    prior pci or cabg
    Beschrijving

    Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1532338
    UMLS CUI [2]
    C0010055
    ongoing acute myocardial infarction and enzymes (ckmb) more than 2x upper limit of normal
    Beschrijving

    Myocardial Infarction | Creatine kinase MB increased

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0861005
    concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement
    Beschrijving

    Heart valve disease Requirement Operative Surgical Procedure | Heart valve disease Requirement Reconstructive Surgical Procedure | Heart valve disease Requirement Surgical replacement

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018824
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0543467
    UMLS CUI [2,1]
    C0018824
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0524865
    UMLS CUI [3,1]
    C0018824
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C4076286
    single or two-vessel disease at time of heart team consensus
    Beschrijving

    Single vessel disease | Double vessel disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0856737
    UMLS CUI [2]
    C0919945
    participation or planned participation in another cardiovascular clinical study before one year follow up is completed
    Beschrijving

    Study Subject Participation Status | Clinical Trial Cardiovascular

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C3887460
    mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol
    Beschrijving

    Mental condition | Mental disorders | Cerebral disorder | Study Protocol Comprehension Unable | Mental Retardation | Language Barriers | Informed Consent Unable | Protocol Compliance Unlikely

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3840291
    UMLS CUI [2]
    C0004936
    UMLS CUI [3]
    C0234387
    UMLS CUI [4,1]
    C2348563
    UMLS CUI [4,2]
    C0162340
    UMLS CUI [4,3]
    C1299582
    UMLS CUI [5]
    C0025362
    UMLS CUI [6]
    C0237167
    UMLS CUI [7,1]
    C0021430
    UMLS CUI [7,2]
    C1299582
    UMLS CUI [8,1]
    C0525058
    UMLS CUI [8,2]
    C0750558
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    Similar models

    Eligibility Heart Diseases NCT02015832

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Stenosis Quantity Angiography | Lesion de novo | Stenosis Diameter Percentage | Left Anterior Descending artery | Left circumflex artery | Right coronary artery
    Item
    at least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. these are left descending coronary artery (lad) and or side branch, proximal circumflex coronary artery (lcx) and or side branch, right descending coronary artery (rca) and or side branch which are supplying viable myocardium without left main involvement. patients with ostial lad or ostial cx medina 0,0,1 or medina 0,1,0 may be enrolled
    boolean
    C1261287 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0002978 (UMLS CUI [1,3])
    C0221198 (UMLS CUI [2,1])
    C1515568 (UMLS CUI [2,2])
    C1261287 (UMLS CUI [3,1])
    C1301886 (UMLS CUI [3,2])
    C0439165 (UMLS CUI [3,3])
    C0226032 (UMLS CUI [4])
    C1305727 (UMLS CUI [5])
    C0226042 (UMLS CUI [6])
    Right coronary artery Hypoplastic | Posterior descending artery Lesion Absent | Left anterior descending artery Lesion | Circumflex artery Lesion | Triple vessel disease Equivalent
    Item
    patients with hypoplastic rca with absence of descending posterior and presence of a lesion in the lad and cx territories may be included in the trial as a 3 vessel disease equivalent
    boolean
    C0226042 (UMLS CUI [1,1])
    C0543481 (UMLS CUI [1,2])
    C0500492 (UMLS CUI [2,1])
    C0221198 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C1321506 (UMLS CUI [3,1])
    C0221198 (UMLS CUI [3,2])
    C1305727 (UMLS CUI [4,1])
    C0221198 (UMLS CUI [4,2])
    C0856738 (UMLS CUI [5,1])
    C0205163 (UMLS CUI [5,2])
    Vessel Size Diameter | Vessel Angiography
    Item
    vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram
    boolean
    C0005847 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    C0005847 (UMLS CUI [2,1])
    C0002978 (UMLS CUI [2,2])
    Patients Have
    Item
    patients with
    boolean
    C0030705 (UMLS CUI [1,1])
    C3539897 (UMLS CUI [1,2])
    Stable angina CCS Class
    Item
    1. stable (canadian cardiovascular society class 1, 2, 3 or 4) angina pectoris
    boolean
    C0340288 (UMLS CUI [1,1])
    C1879987 (UMLS CUI [1,2])
    Unstable Angina Classification
    Item
    2. or unstable (braunwald class) angina pectoris and ischemia
    boolean
    C0002965 (UMLS CUI [1,1])
    C0008902 (UMLS CUI [1,2])
    Atypical chest pain | Myocardial Ischemia Asymptomatic | Stress test treadmill | Radionuclide Imaging | Stress Echocardiography
    Item
    3. or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography
    boolean
    C0262384 (UMLS CUI [1])
    C0151744 (UMLS CUI [2,1])
    C0231221 (UMLS CUI [2,2])
    C3878122 (UMLS CUI [3])
    C0034606 (UMLS CUI [4])
    C0038435 (UMLS CUI [5,1])
    C0013516 (UMLS CUI [5,2])
    Coronary Artery Disease Score
    Item
    all anatomical syntax scores are eligible for initial screening with the syntax score ii
    boolean
    C1956346 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Informed Consent
    Item
    patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee of the respective clinical site
    boolean
    C0021430 (UMLS CUI [1])
    Cardiologist Approval | Surgeon Approval | Eligibility Criteria Fulfill
    Item
    signed heart team decision form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria
    boolean
    C0175906 (UMLS CUI [1,1])
    C0205540 (UMLS CUI [1,2])
    C0582175 (UMLS CUI [2,1])
    C0205540 (UMLS CUI [2,2])
    C1516637 (UMLS CUI [3,1])
    C1550543 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Age
    Item
    under the age of 21 years
    boolean
    C0001779 (UMLS CUI [1])
    Pregnancy | Childbearing Potential Contraceptive methods Absent | Breast Feeding
    Item
    known pregnancy at time of enrolment. female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. female who is breastfeeding at time of enrolment
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C0006147 (UMLS CUI [3])
    Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
    Item
    prior pci or cabg
    boolean
    C1532338 (UMLS CUI [1])
    C0010055 (UMLS CUI [2])
    Myocardial Infarction | Creatine kinase MB increased
    Item
    ongoing acute myocardial infarction and enzymes (ckmb) more than 2x upper limit of normal
    boolean
    C0027051 (UMLS CUI [1])
    C0861005 (UMLS CUI [2])
    Heart valve disease Requirement Operative Surgical Procedure | Heart valve disease Requirement Reconstructive Surgical Procedure | Heart valve disease Requirement Surgical replacement
    Item
    concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement
    boolean
    C0018824 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C0018824 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0524865 (UMLS CUI [2,3])
    C0018824 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C4076286 (UMLS CUI [3,3])
    Single vessel disease | Double vessel disease
    Item
    single or two-vessel disease at time of heart team consensus
    boolean
    C0856737 (UMLS CUI [1])
    C0919945 (UMLS CUI [2])
    Study Subject Participation Status | Clinical Trial Cardiovascular
    Item
    participation or planned participation in another cardiovascular clinical study before one year follow up is completed
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C3887460 (UMLS CUI [2,2])
    Mental condition | Mental disorders | Cerebral disorder | Study Protocol Comprehension Unable | Mental Retardation | Language Barriers | Informed Consent Unable | Protocol Compliance Unlikely
    Item
    mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol
    boolean
    C3840291 (UMLS CUI [1])
    C0004936 (UMLS CUI [2])
    C0234387 (UMLS CUI [3])
    C2348563 (UMLS CUI [4,1])
    C0162340 (UMLS CUI [4,2])
    C1299582 (UMLS CUI [4,3])
    C0025362 (UMLS CUI [5])
    C0237167 (UMLS CUI [6])
    C0021430 (UMLS CUI [7,1])
    C1299582 (UMLS CUI [7,2])
    C0525058 (UMLS CUI [8,1])
    C0750558 (UMLS CUI [8,2])
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