ID

37478

Beschrijving

Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm; ODM derived from: https://clinicaltrials.gov/show/NCT01266681

Link

https://clinicaltrials.gov/show/NCT01266681

Trefwoorden

Versies (1)
  1. 31-07-19 31-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

31 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01266681

Engels

Eligibility Atrial Fibrillation NCT01266681

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
• patients with persaf requiring dc cardioversion.
Beschrijving

Persistent atrial fibrillation | Requirement Direct current cardioversion

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0542380
patients must be over 18 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients give informed consent form prior to participating in this study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients must be on warfarin for at least 4 weeks or a transoesphageal echo must be performed at the time of dc cardioversion.
Beschrijving

Warfarin therapy | Echocardiography, Transesophageal

Datatype

boolean

Alias
UMLS CUI [1]
C4303340
UMLS CUI [2]
C0206054
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
• patient is suffering with unstable angina in last 1 week.
Beschrijving

Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
patient has had a myocardial infarction within last 2 months.
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
patient is expecting or has had major cardiac surgery within last 2 months.
Beschrijving

Cardiac Surgery Major Expected | Cardiac Surgery Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C0205164
patient is participating in a conflicting study.
Beschrijving

Study Subject Participation Status Interferes with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
patient is mentally incapacitated and cannot consent or comply with follow-up.
Beschrijving

Mental handicap | Informed Consent Unable | Compliance Lacking Follow-up

Datatype

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
UMLS CUI [3,3]
C3274571
patient has nyha class iii/ iv heart failure.
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
pregnancy.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patient suffers with other cardiac rhythm disorders.
Beschrijving

Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
recent coronary artery intervention or other factors suggesting clinical instability (ecg, clinical or laboratory findings).
Beschrijving

Coronary artery Intervention | Factor Suggestive of Instability Clinical | ECG | Clinical findings | Laboratory finding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0184661
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C1444783
UMLS CUI [2,4]
C0205210
UMLS CUI [3]
C0013798
UMLS CUI [4]
C0037088
UMLS CUI [5]
C0587081
gfr<30mls/min.
Beschrijving

Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0017654
patients has a contraindication to amiodarone or dronedarone
Beschrijving

Medical contraindication Amiodarone | Medical contraindication Dronedarone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002598
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0766326
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Similar models

Eligibility Atrial Fibrillation NCT01266681

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Persistent atrial fibrillation | Requirement Direct current cardioversion
Item
• patients with persaf requiring dc cardioversion.
boolean
C2585653 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0542380 (UMLS CUI [2,2])
Age
Item
patients must be over 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients give informed consent form prior to participating in this study.
boolean
C0021430 (UMLS CUI [1])
Warfarin therapy | Echocardiography, Transesophageal
Item
patients must be on warfarin for at least 4 weeks or a transoesphageal echo must be performed at the time of dc cardioversion.
boolean
C4303340 (UMLS CUI [1])
C0206054 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Angina, Unstable
Item
• patient is suffering with unstable angina in last 1 week.
boolean
C0002965 (UMLS CUI [1])
Myocardial Infarction
Item
patient has had a myocardial infarction within last 2 months.
boolean
C0027051 (UMLS CUI [1])
Cardiac Surgery Major Expected | Cardiac Surgery Major
Item
patient is expecting or has had major cardiac surgery within last 2 months.
boolean
C0018821 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0018821 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Clinical Trial
Item
patient is participating in a conflicting study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Mental handicap | Informed Consent Unable | Compliance Lacking Follow-up
Item
patient is mentally incapacitated and cannot consent or comply with follow-up.
boolean
C1306341 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification
Item
patient has nyha class iii/ iv heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Cardiac Arrhythmia
Item
patient suffers with other cardiac rhythm disorders.
boolean
C0003811 (UMLS CUI [1])
Coronary artery Intervention | Factor Suggestive of Instability Clinical | ECG | Clinical findings | Laboratory finding
Item
recent coronary artery intervention or other factors suggesting clinical instability (ecg, clinical or laboratory findings).
boolean
C0205042 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1521761 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C1444783 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C0013798 (UMLS CUI [3])
C0037088 (UMLS CUI [4])
C0587081 (UMLS CUI [5])
Glomerular Filtration Rate
Item
gfr<30mls/min.
boolean
C0017654 (UMLS CUI [1])
Medical contraindication Amiodarone | Medical contraindication Dronedarone
Item
patients has a contraindication to amiodarone or dronedarone
boolean
C1301624 (UMLS CUI [1,1])
C0002598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0766326 (UMLS CUI [2,2])
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