ID

14647

Description

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

Link

https://clinicaltrials.gov/show/NCT02347111

Keywords

  1. 4/25/16 4/25/16 -
Uploaded on

April 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02347111

Eligibility Atrial Fibrillation NCT02347111

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
caucasians ≥ 18 years of age
Description

Caucasians Age

Data type

boolean

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

ATRIAL FIBRILLATION SYMPTOMATIC Typical | Lone atrial fibrillation

Data type

boolean

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

Atrial Fibrillation Symptoms

Data type

boolean

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

Electrocardiography Atrial Fibrillation | Randomization

Data type

boolean

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

Class I antiarrhythmic drug | Class III antiarrhythmic drug

Data type

boolean

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

Sinus rhythm

Data type

boolean

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

Ability Informed Consent

Data type

boolean

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

Exclusion Criteria

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

Permanent atrial fibrillation | Isolated Atrial Flutter

Data type

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
Description

Cardiac Surgery procedures | Thoracic Surgical Procedures

Data type

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)
Description

Use of Amiodarone | Cardiac Arrhythmia | Hospitals

Data type

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
Description

Disease Probably Fatal

Data type

boolean

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

Anti-Arrhythmia Agents Past

Data type

boolean

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

Creatinine clearance measurement

Data type

boolean

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

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

Data type

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
Description

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

Data type

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)
Description

Reversible cause Atrial Fibrillation | Thyrotoxicosis

Data type

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
Description

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Atrioventricular node Severe dysfunction | electronic pacemaker

Data type

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
Description

Other Racial group | Caucasians

Data type

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.
Description

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

Data type

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)
Data type
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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