ID

37612

Descripción

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02145546

Link

https://clinicaltrials.gov/show/NCT02145546

Palabras clave

Versiones (1)
  1. 11/8/19 11/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02145546

Inglés

Eligibility Atrial Fibrillation NCT02145546

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
sick sinus syndrome with pacemaker class i or class iia indication
Descripción

Sick Sinus Syndrome | Indication Artificial cardiac pacemaker Class

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037052
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0030163
UMLS CUI [2,3]
C0456387
has a pacemaker which can provide the daily af burden monitor record for at least 28 days
Descripción

Artificial cardiac pacemaker | Atrial Fibrillation Burden Monitor Record

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C2828008
UMLS CUI [2,3]
C0596972
UMLS CUI [2,4]
C0034869
has at af record in the past 6 months, the valid af record includes any of
Descripción

Atrial Fibrillation Record

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0034869
1. at least one 30 seconds af holter record
Descripción

Atrial Fibrillation Holter Electrocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0013801
2. at least one 15 seconds 12-ecg record
Descripción

Atrial Fibrillation 12 lead ECG

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0430456
3. at least 5 minutes long af episodes record from pacemakers
Descripción

Atrial Fibrillation Episode Duration Record | Artificial cardiac pacemaker

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C0034869
UMLS CUI [2]
C0030163
able and willing to give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation
Descripción

Cardiac Surgery Expected | Patient on waiting list Heart Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0018823
nyha class iii or iv
Descripción

New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275491
lvef <50%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
reversible af, such as af caused by hyperthyroidism or severe postoperative atrial fibrillation
Descripción

Atrial Fibrillation Reversible | Atrial Fibrillation caused by Hyperthyroidism | Atrial Fibrillation Postoperative Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205343
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0020550
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0032790
UMLS CUI [3,3]
C0205082
persistence af
Descripción

Persistent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2585653
expected life expectancy less than 1 year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
planned to be pregnant or be in the feeding period in the next year
Descripción

Pregnancy, Planned | Breast Feeding Year Next

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0439234
UMLS CUI [2,3]
C0332282
non-stable, decompensated heart failure
Descripción

Decompensated cardiac failure Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0443343
allergy to amiodarone, propafenone or sotalol
Descripción

Amiodarone allergy | Propafenone allergy | Sotalol allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571891
UMLS CUI [2]
C0571886
UMLS CUI [3]
C0570902
cancer
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
clear liver damage ( alt and/or ast > 2*normal limit)
Descripción

Liver damage | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151763
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
patients with cardiogenic shock history
Descripción

Shock, Cardiogenic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036980
be in the treatment of amiodarone for more than 3 months or less than 3 months with amiodarone wash out period less than 30 days
Descripción

Amiodarone therapy | Washout Period

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4303555
UMLS CUI [2]
C1710661
coronary artery disease (chd), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (copd), long qt syndrome
Descripción

Coronary Artery Disease | Cardiomyopathy | Heart valve disease Severe | Severe chronic obstructive pulmonary disease | Long QT Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0018824
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0730607
UMLS CUI [5]
C0023976
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Similar models

Eligibility Atrial Fibrillation NCT02145546

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Sick Sinus Syndrome | Indication Artificial cardiac pacemaker Class
Item
sick sinus syndrome with pacemaker class i or class iia indication
boolean
C0037052 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0030163 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
Artificial cardiac pacemaker | Atrial Fibrillation Burden Monitor Record
Item
has a pacemaker which can provide the daily af burden monitor record for at least 28 days
boolean
C0030163 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C2828008 (UMLS CUI [2,2])
C0596972 (UMLS CUI [2,3])
C0034869 (UMLS CUI [2,4])
Atrial Fibrillation Record
Item
has at af record in the past 6 months, the valid af record includes any of
boolean
C0004238 (UMLS CUI [1,1])
C0034869 (UMLS CUI [1,2])
Atrial Fibrillation Holter Electrocardiography
Item
1. at least one 30 seconds af holter record
boolean
C0004238 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Atrial Fibrillation 12 lead ECG
Item
2. at least one 15 seconds 12-ecg record
boolean
C0004238 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Atrial Fibrillation Episode Duration Record | Artificial cardiac pacemaker
Item
3. at least 5 minutes long af episodes record from pacemakers
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0034869 (UMLS CUI [1,4])
C0030163 (UMLS CUI [2])
Informed Consent
Item
able and willing to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiac Surgery Expected | Patient on waiting list Heart Transplantation
Item
will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation
boolean
C0018821 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
New York Heart Association Classification
Item
nyha class iii or iv
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef <50%
boolean
C0428772 (UMLS CUI [1])
Atrial Fibrillation Reversible | Atrial Fibrillation caused by Hyperthyroidism | Atrial Fibrillation Postoperative Severe
Item
reversible af, such as af caused by hyperthyroidism or severe postoperative atrial fibrillation
boolean
C0004238 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0020550 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
Persistent atrial fibrillation
Item
persistence af
boolean
C2585653 (UMLS CUI [1])
Life Expectancy
Item
expected life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Pregnancy, Planned | Breast Feeding Year Next
Item
planned to be pregnant or be in the feeding period in the next year
boolean
C0032992 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
Decompensated cardiac failure Unstable
Item
non-stable, decompensated heart failure
boolean
C0581377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Amiodarone allergy | Propafenone allergy | Sotalol allergy
Item
allergy to amiodarone, propafenone or sotalol
boolean
C0571891 (UMLS CUI [1])
C0571886 (UMLS CUI [2])
C0570902 (UMLS CUI [3])
Malignant Neoplasms
Item
cancer
boolean
C0006826 (UMLS CUI [1])
Liver damage | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
clear liver damage ( alt and/or ast > 2*normal limit)
boolean
C0151763 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Shock, Cardiogenic
Item
patients with cardiogenic shock history
boolean
C0036980 (UMLS CUI [1])
Amiodarone therapy | Washout Period
Item
be in the treatment of amiodarone for more than 3 months or less than 3 months with amiodarone wash out period less than 30 days
boolean
C4303555 (UMLS CUI [1])
C1710661 (UMLS CUI [2])
Coronary Artery Disease | Cardiomyopathy | Heart valve disease Severe | Severe chronic obstructive pulmonary disease | Long QT Syndrome
Item
coronary artery disease (chd), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (copd), long qt syndrome
boolean
C1956346 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0018824 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0730607 (UMLS CUI [4])
C0023976 (UMLS CUI [5])
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