ID

43662

Description

Autonomic Innervation and MIBG Imaging; ODM derived from: https://clinicaltrials.gov/show/NCT02071680

Link

https://clinicaltrials.gov/show/NCT02071680

Keywords

Versions (2)
  1. 4/25/16 4/25/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02071680

English

Eligibility Atrial Fibrillation NCT02071680

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-80 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
symptoms including one or more of the following: palpitations, shortness of breath, dizziness, presyncope or syncope, chest pain, tiredness or lack of energy.
Description

Symptoms | Palpitations | Dyspnea | Dizziness | Presyncope | Syncope | Chest Pain | Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0030252
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0012833
UMLS CUI [5]
C0700200
UMLS CUI [6]
C0039070
UMLS CUI [7]
C0008031
UMLS CUI [8]
C0015672
failure of beta-blockers or at least one antiarrhythmic agent other than amiodarone to prevent af. in those patients who are not eligible to antiarrhythmic agents other than amiodarone, patients may choose to undergo catheter ablation rather than starting amiodarone.
Description

Unsuccessful Adrenergic beta-Antagonists | Unsuccessful Anti-Arrhythmia Agents | Amiodarone | Atrial Fibrillation | Cardiac ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C1272705
UMLS CUI [1,2]
C0001645
UMLS CUI [2,1]
C1272705
UMLS CUI [2,2]
C0003195
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0004238
UMLS CUI [5]
C0162563
paroxysmal (self-terminating af within 7 days) or persistent af (requiring an intervention to terminate or lasting more than 7 days).
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Interventional procedure

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C0184661
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
intracardiac thrombus as determined by transesophageal echocardiography
Description

Intracardiac thrombus Echocardiography, Transesophageal

Data type

boolean

Alias
UMLS CUI [1,1]
C0876998
UMLS CUI [1,2]
C0206054
class iii or iv congestive heart failure
Description

Congestive heart failure New York Heart Association class III/IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0278962
persistent af duration of more than 3 years
Description

Persistent atrial fibrillation Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0449238
myocardial infarction within the last 6 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
left atrial size of greater than 55 mm determined by 2d echocardiogram
Description

Left atrial structure Size | Echocardiography second

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C0205436
inability to undergo a transesophageal echocardiogram or cardiac ct
Description

Unable Echocardiography, Transesophageal | Unable Cardiac CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0206054
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C0412618
inability to undergo d-spect™ imaging
Description

Unable Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0011923
inability to take warfarin or the new oral anticoagulants
Description

Unable Intake Warfarin | Unable Intake oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0043031
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0354604
previously received 123i-mibg or 131i-mibg
Description

3-Iodobenzylguanidine 131I-MIBG

Data type

boolean

Alias
UMLS CUI [1,1]
C0047506
UMLS CUI [1,2]
C0524959
history or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents
Description

Allergic Reaction Iodine | Allergic Reaction Iodinated Contrast Agent for Radiographic Imaging | anaphylaxis Iodine | anaphylaxis Iodinated Contrast Agent for Radiographic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0021968
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2917375
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0021968
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C2917375
use of medications for non-cardiac medical conditions that are known to interfere with 123i-mibg uptake and these medications cannot be safely withheld for at least 24 hours before study procedures
Description

Pharmaceutical Preparations Disease Affecting 3-Iodobenzylguanidine

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0047506
diagnosis of or signs or symptoms of a neurologic disease such as parkinson's disease, multiple systems atrophy or parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system
Description

nervous system disorder | Parkinson Disease | Multiple System Atrophy | Parkinsonian Disorders | Sympathetic Nervous System

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0393571
UMLS CUI [4]
C0242422
UMLS CUI [5]
C0039044
pregnancy as determined by a pre-procedure pregnancy tests
Description

Pregnancy Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
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Similar models

Eligibility Atrial Fibrillation NCT02071680

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-80 years.
boolean
C0001779 (UMLS CUI [1])
Symptoms | Palpitations | Dyspnea | Dizziness | Presyncope | Syncope | Chest Pain | Fatigue
Item
symptoms including one or more of the following: palpitations, shortness of breath, dizziness, presyncope or syncope, chest pain, tiredness or lack of energy.
boolean
C1457887 (UMLS CUI [1])
C0030252 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0012833 (UMLS CUI [4])
C0700200 (UMLS CUI [5])
C0039070 (UMLS CUI [6])
C0008031 (UMLS CUI [7])
C0015672 (UMLS CUI [8])
Unsuccessful Adrenergic beta-Antagonists | Unsuccessful Anti-Arrhythmia Agents | Amiodarone | Atrial Fibrillation | Cardiac ablation
Item
failure of beta-blockers or at least one antiarrhythmic agent other than amiodarone to prevent af. in those patients who are not eligible to antiarrhythmic agents other than amiodarone, patients may choose to undergo catheter ablation rather than starting amiodarone.
boolean
C1272705 (UMLS CUI [1,1])
C0001645 (UMLS CUI [1,2])
C1272705 (UMLS CUI [2,1])
C0003195 (UMLS CUI [2,2])
C0002598 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
C0162563 (UMLS CUI [5])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Interventional procedure
Item
paroxysmal (self-terminating af within 7 days) or persistent af (requiring an intervention to terminate or lasting more than 7 days).
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0184661 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Intracardiac thrombus Echocardiography, Transesophageal
Item
intracardiac thrombus as determined by transesophageal echocardiography
boolean
C0876998 (UMLS CUI [1,1])
C0206054 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association class III/IV
Item
class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0278962 (UMLS CUI [1,2])
Persistent atrial fibrillation Duration
Item
persistent af duration of more than 3 years
boolean
C2585653 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
Left atrial structure Size | Echocardiography second
Item
left atrial size of greater than 55 mm determined by 2d echocardiogram
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Unable Echocardiography, Transesophageal | Unable Cardiac CT
Item
inability to undergo a transesophageal echocardiogram or cardiac ct
boolean
C1299582 (UMLS CUI [1,1])
C0206054 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0412618 (UMLS CUI [2,2])
Unable Diagnostic Imaging
Item
inability to undergo d-spect™ imaging
boolean
C1299582 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Unable Intake Warfarin | Unable Intake oral anticoagulants
Item
inability to take warfarin or the new oral anticoagulants
boolean
C1299582 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0043031 (UMLS CUI [1,3])
C1299582 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0354604 (UMLS CUI [2,3])
3-Iodobenzylguanidine 131I-MIBG
Item
previously received 123i-mibg or 131i-mibg
boolean
C0047506 (UMLS CUI [1,1])
C0524959 (UMLS CUI [1,2])
Allergic Reaction Iodine | Allergic Reaction Iodinated Contrast Agent for Radiographic Imaging | anaphylaxis Iodine | anaphylaxis Iodinated Contrast Agent for Radiographic Imaging
Item
history or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents
boolean
C1527304 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C2917375 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C0021968 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C2917375 (UMLS CUI [4,2])
Pharmaceutical Preparations Disease Affecting 3-Iodobenzylguanidine
Item
use of medications for non-cardiac medical conditions that are known to interfere with 123i-mibg uptake and these medications cannot be safely withheld for at least 24 hours before study procedures
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0047506 (UMLS CUI [1,4])
nervous system disorder | Parkinson Disease | Multiple System Atrophy | Parkinsonian Disorders | Sympathetic Nervous System
Item
diagnosis of or signs or symptoms of a neurologic disease such as parkinson's disease, multiple systems atrophy or parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system
boolean
C0027765 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0393571 (UMLS CUI [3])
C0242422 (UMLS CUI [4])
C0039044 (UMLS CUI [5])
Pregnancy Pregnancy Tests
Item
pregnancy as determined by a pre-procedure pregnancy tests
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
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