ID

14647

Beschrijving

Pilot Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02347111

Link

https://clinicaltrials.gov/show/NCT02347111

Trefwoorden

  1. 25-04-16 25-04-16 -
Geüploaded op

25 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Atrial Fibrillation NCT02347111

    Eligibility Atrial Fibrillation NCT02347111

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    caucasians ≥ 18 years of age
    Beschrijving

    Caucasians Age

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0043157
    UMLS CUI [1,2]
    C0001779
    history of typical or lone symptomatic af
    Beschrijving

    ATRIAL FIBRILLATION SYMPTOMATIC Typical | Lone atrial fibrillation

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0741283
    UMLS CUI [1,2]
    C3538928
    UMLS CUI [2]
    C0340489
    af symptoms present at least once per month
    Beschrijving

    Atrial Fibrillation Symptoms

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0004238
    UMLS CUI [1,2]
    C1457887
    ecg that was recorded within 12 months of randomization showing af
    Beschrijving

    Electrocardiography Atrial Fibrillation | Randomization

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0004238
    UMLS CUI [2]
    C0034656
    starting a class i or class iii aad
    Beschrijving

    Class I antiarrhythmic drug | Class III antiarrhythmic drug

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0360692
    UMLS CUI [2]
    C0360703
    in sinus rhythm at enrollment
    Beschrijving

    Sinus rhythm

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232201
    able to give informed consent
    Beschrijving

    Ability Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    permanent af or isolated atrial flutter.
    Beschrijving

    Permanent atrial fibrillation | Isolated Atrial Flutter

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2586056
    UMLS CUI [2,1]
    C0004239
    UMLS CUI [2,2]
    C0205409
    cardiac or thoracic surgery within the previous 6 months
    Beschrijving

    Cardiac Surgery procedures | Thoracic Surgical Procedures

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0018821
    UMLS CUI [2]
    C0524832
    previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
    Beschrijving

    Use of Amiodarone | Cardiac Arrhythmia | Hospitals

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0002598
    UMLS CUI [2]
    C0003811
    UMLS CUI [3]
    C0019994
    medical condition that is likely to be fatal in less than one year
    Beschrijving

    Disease Probably Fatal

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0750492
    UMLS CUI [1,3]
    C1302234
    received 2 or more aads in past
    Beschrijving

    Anti-Arrhythmia Agents Past

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0003195
    UMLS CUI [1,2]
    C1444637
    creatinine clearance <40 ml/min
    Beschrijving

    Creatinine clearance measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    contra-indication to a class i aad e.g., structural heart disease, or history of mi
    Beschrijving

    Medical contraindication Class I antiarrhythmic drug | Structural disorder of heart | Myocardial Infarction

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0360692
    UMLS CUI [2]
    C1290384
    UMLS CUI [3]
    C0027051
    contra-indication to a class iii aad, e.g., congenital or acquired long qt syndrome with qtc>450 ms at baseline
    Beschrijving

    Medical contraindication Class III antiarrhythmic drug | Congenital long QT syndrome | Acquired long QT syndrome | QTc

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0360703
    UMLS CUI [2]
    C1141890
    UMLS CUI [3]
    C2732979
    UMLS CUI [4]
    C0860814
    a reversible cause of af (e.g., thyrotoxicosis)
    Beschrijving

    Reversible cause Atrial Fibrillation | Thyrotoxicosis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205343
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C0004238
    UMLS CUI [2]
    C0040156
    previously treated with class i and class iii antiarrhythmic drugs
    Beschrijving

    Prior Therapy Class I antiarrhythmic drug | Prior Therapy Class III antiarrhythmic drug

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0360692
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0360703
    females who are pregnant or nursing.
    Beschrijving

    Pregnancy | Breast Feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    history of severe av node dysfunction unless an electronic pacemaker is present
    Beschrijving

    Atrioventricular node Severe dysfunction | electronic pacemaker

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0004247
    UMLS CUI [1,2]
    C3887504
    UMLS CUI [1,3]
    C0205082
    UMLS CUI [2]
    C0178611
    any race other than caucasian
    Beschrijving

    Other Racial group | Caucasians

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0043157
    first- or second-degree relative has already participated in the study.
    Beschrijving

    Study Subject Participation Status | Relative First degree | Relative Second degree

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C0080103
    UMLS CUI [2,2]
    C0444502
    UMLS CUI [3,1]
    C0080103
    UMLS CUI [3,2]
    C0443298

    Similar models

    Eligibility Atrial Fibrillation NCT02347111

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Caucasians Age
    Item
    caucasians ≥ 18 years of age
    boolean
    C0043157 (UMLS CUI [1,1])
    C0001779 (UMLS CUI [1,2])
    ATRIAL FIBRILLATION SYMPTOMATIC Typical | Lone atrial fibrillation
    Item
    history of typical or lone symptomatic af
    boolean
    C0741283 (UMLS CUI [1,1])
    C3538928 (UMLS CUI [1,2])
    C0340489 (UMLS CUI [2])
    Atrial Fibrillation Symptoms
    Item
    af symptoms present at least once per month
    boolean
    C0004238 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Electrocardiography Atrial Fibrillation | Randomization
    Item
    ecg that was recorded within 12 months of randomization showing af
    boolean
    C1623258 (UMLS CUI [1,1])
    C0004238 (UMLS CUI [1,2])
    C0034656 (UMLS CUI [2])
    Class I antiarrhythmic drug | Class III antiarrhythmic drug
    Item
    starting a class i or class iii aad
    boolean
    C0360692 (UMLS CUI [1])
    C0360703 (UMLS CUI [2])
    Sinus rhythm
    Item
    in sinus rhythm at enrollment
    boolean
    C0232201 (UMLS CUI [1])
    Ability Informed Consent
    Item
    able to give informed consent
    boolean
    C0085732 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Permanent atrial fibrillation | Isolated Atrial Flutter
    Item
    permanent af or isolated atrial flutter.
    boolean
    C2586056 (UMLS CUI [1])
    C0004239 (UMLS CUI [2,1])
    C0205409 (UMLS CUI [2,2])
    Cardiac Surgery procedures | Thoracic Surgical Procedures
    Item
    cardiac or thoracic surgery within the previous 6 months
    boolean
    C0018821 (UMLS CUI [1])
    C0524832 (UMLS CUI [2])
    Use of Amiodarone | Cardiac Arrhythmia | Hospitals
    Item
    previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
    boolean
    C1524063 (UMLS CUI [1,1])
    C0002598 (UMLS CUI [1,2])
    C0003811 (UMLS CUI [2])
    C0019994 (UMLS CUI [3])
    Disease Probably Fatal
    Item
    medical condition that is likely to be fatal in less than one year
    boolean
    C0012634 (UMLS CUI [1,1])
    C0750492 (UMLS CUI [1,2])
    C1302234 (UMLS CUI [1,3])
    Anti-Arrhythmia Agents Past
    Item
    received 2 or more aads in past
    boolean
    C0003195 (UMLS CUI [1,1])
    C1444637 (UMLS CUI [1,2])
    Creatinine clearance measurement
    Item
    creatinine clearance <40 ml/min
    boolean
    C0373595 (UMLS CUI [1])
    Medical contraindication Class I antiarrhythmic drug | Structural disorder of heart | Myocardial Infarction
    Item
    contra-indication to a class i aad e.g., structural heart disease, or history of mi
    boolean
    C1301624 (UMLS CUI [1,1])
    C0360692 (UMLS CUI [1,2])
    C1290384 (UMLS CUI [2])
    C0027051 (UMLS CUI [3])
    Medical contraindication Class III antiarrhythmic drug | Congenital long QT syndrome | Acquired long QT syndrome | QTc
    Item
    contra-indication to a class iii aad, e.g., congenital or acquired long qt syndrome with qtc>450 ms at baseline
    boolean
    C1301624 (UMLS CUI [1,1])
    C0360703 (UMLS CUI [1,2])
    C1141890 (UMLS CUI [2])
    C2732979 (UMLS CUI [3])
    C0860814 (UMLS CUI [4])
    Reversible cause Atrial Fibrillation | Thyrotoxicosis
    Item
    a reversible cause of af (e.g., thyrotoxicosis)
    boolean
    C0205343 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0004238 (UMLS CUI [1,3])
    C0040156 (UMLS CUI [2])
    Prior Therapy Class I antiarrhythmic drug | Prior Therapy Class III antiarrhythmic drug
    Item
    previously treated with class i and class iii antiarrhythmic drugs
    boolean
    C1514463 (UMLS CUI [1,1])
    C0360692 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C0360703 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    females who are pregnant or nursing.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Atrioventricular node Severe dysfunction | electronic pacemaker
    Item
    history of severe av node dysfunction unless an electronic pacemaker is present
    boolean
    C0004247 (UMLS CUI [1,1])
    C3887504 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    C0178611 (UMLS CUI [2])
    Other Racial group | Caucasians
    Item
    any race other than caucasian
    boolean
    C0034510 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0043157 (UMLS CUI [2])
    Study Subject Participation Status | Relative First degree | Relative Second degree
    Item
    first- or second-degree relative has already participated in the study.
    boolean
    C2348568 (UMLS CUI [1])
    C0080103 (UMLS CUI [2,1])
    C0444502 (UMLS CUI [2,2])
    C0080103 (UMLS CUI [3,1])
    C0443298 (UMLS CUI [3,2])

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