ID

37473

Description

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01151137

Link

https://clinicaltrials.gov/show/NCT01151137

Keywords

Versions (1)
  1. 7/31/19 7/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01151137

English

Eligibility Atrial Fibrillation NCT01151137

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
permanent af defined by the presence of all of the following criteria:
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
availability of one 12-lead ecg not more than 14 days prior to randomization showing that the patient is in af or atrial flutter;
Description

Atrial Fibrillation 12 lead ECG | Atrial Flutter 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0430456
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0430456
availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in af or atrial flutter at least 6 months prior to randomization;
Description

Atrial Fibrillation Disease length Documentation | Atrial Flutter Disease length Documentation | Atrial Fibrillation Disease length ECG rhythm strip | Atrial Flutter Disease length ECG rhythm strip

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C0920316
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0872146
UMLS CUI [2,3]
C0920316
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0872146
UMLS CUI [3,3]
C2022160
UMLS CUI [4,1]
C0004239
UMLS CUI [4,2]
C0872146
UMLS CUI [4,3]
C2022160
no evidence of sinus rhythm in the period between these two documentations of af;
Description

Sinus rhythm Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0332197
decision of the patient and physician to allow af to continue without further efforts to restore sinus rhythm.
Description

Atrial Fibrillation Continue allowed | Lacking Attempt Restore Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C1516084
UMLS CUI [2,3]
C1283255
UMLS CUI [2,4]
C0232201
at least one of the following risk criteria:
Description

Risk Criteria Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1265611
coronary artery disease;
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
prior stroke or transient ischemic attack [tia];
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
symptomatic heart failure;
Description

Heart failure Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
left ventricular ejection fraction [lvef] less or equal to 0.40;
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
peripheral arterial occlusive disease;
Description

Peripheral arterial occlusive disease

Data type

boolean

Alias
UMLS CUI [1]
C1306889
aged 75 years or older with both hypertension and diabetes mellitus.
Description

Age | Hypertensive disease | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0011849
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
paroxysmal af;
Description

Paroxysmal atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
persistent af without a decision to allow af to continue without further efforts to restore sinus rhythm;
Description

Persistent atrial fibrillation | Decision Absent | Atrial Fibrillation Continue allowing | Lacking Attempt Restore Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0549178
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0332268
UMLS CUI [4,2]
C1516084
UMLS CUI [4,3]
C1283255
UMLS CUI [4,4]
C0232201
heart failure of new-york heart association [nyha] class iv or recent unstable nyha class iii.
Description

Heart failure New York Heart Association Classification | Heart failure Unstable New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C1275491
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status Considerations Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0518609
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Atrial Fibrillation NCT01151137

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Permanent atrial fibrillation
Item
permanent af defined by the presence of all of the following criteria:
boolean
C2586056 (UMLS CUI [1])
Atrial Fibrillation 12 lead ECG | Atrial Flutter 12 lead ECG
Item
availability of one 12-lead ecg not more than 14 days prior to randomization showing that the patient is in af or atrial flutter;
boolean
C0004238 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0004239 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Atrial Fibrillation Disease length Documentation | Atrial Flutter Disease length Documentation | Atrial Fibrillation Disease length ECG rhythm strip | Atrial Flutter Disease length ECG rhythm strip
Item
availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in af or atrial flutter at least 6 months prior to randomization;
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C0004239 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0920316 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C2022160 (UMLS CUI [3,3])
C0004239 (UMLS CUI [4,1])
C0872146 (UMLS CUI [4,2])
C2022160 (UMLS CUI [4,3])
Sinus rhythm Absent
Item
no evidence of sinus rhythm in the period between these two documentations of af;
boolean
C0232201 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Atrial Fibrillation Continue allowed | Lacking Attempt Restore Sinus rhythm
Item
decision of the patient and physician to allow af to continue without further efforts to restore sinus rhythm.
boolean
C0004238 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C1283255 (UMLS CUI [2,3])
C0232201 (UMLS CUI [2,4])
Risk Criteria Quantity
Item
at least one of the following risk criteria:
boolean
C0035647 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Coronary Artery Disease
Item
coronary artery disease;
boolean
C1956346 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or transient ischemic attack [tia];
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Heart failure Symptomatic
Item
symptomatic heart failure;
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction [lvef] less or equal to 0.40;
boolean
C0428772 (UMLS CUI [1])
Peripheral arterial occlusive disease
Item
peripheral arterial occlusive disease;
boolean
C1306889 (UMLS CUI [1])
Age | Hypertensive disease | Diabetes Mellitus
Item
aged 75 years or older with both hypertension and diabetes mellitus.
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
paroxysmal af;
boolean
C0235480 (UMLS CUI [1])
Persistent atrial fibrillation | Decision Absent | Atrial Fibrillation Continue allowing | Lacking Attempt Restore Sinus rhythm
Item
persistent af without a decision to allow af to continue without further efforts to restore sinus rhythm;
boolean
C2585653 (UMLS CUI [1])
C0679006 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0332268 (UMLS CUI [4,1])
C1516084 (UMLS CUI [4,2])
C1283255 (UMLS CUI [4,3])
C0232201 (UMLS CUI [4,4])
Heart failure New York Heart Association Classification | Heart failure Unstable New York Heart Association Classification
Item
heart failure of new-york heart association [nyha] class iv or recent unstable nyha class iii.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Study Subject Participation Status Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C0518609 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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