ID

13385

Description

Atrial Fibrillation and Congestive Heart Failure Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00597077

Link

https://clinicaltrials.gov/show/NCT00597077

Keywords

Versions (1)
  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00597077

English

Eligibility Atrial Fibrillation NCT00597077

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. left ventricular ejection fraction </=35% as measured by nuclear imaging, echocardiography, or cardiac angiography within 6 months preceding enrollment. if the patient has had a myocardial infarction or heart surgery during this period, the ejection fraction must be remeasured.
Description

left ventricular ejection fraction

Data type

boolean

2. symptomatic CHF (nyha class ii-iv) at some time during the 6 months before randomization, despite therapy with an ace inhibitor (however, patients who do not tolerate an ace inhibitor are eligible). asymptomatic patients (nyha class i) with either a prior hospitalization for chf during the 6 months before randomization or with a left ventricular ejection fraction of </=25% are also eligible.
Description

symptomatic CHF

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C1275491
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0018802
UMLS CUI [4]
C0428772
3. history of significant AF, defined as either: 1. one episode lasting >/=6 hours (duration of af will be determined by history), within the past 6 months with electrocardiographic confirmation; or 2. an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for af.
Description

AF

Data type

boolean

Alias
UMLS CUI [1]
C0004238
4. in the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of af.
Description

eligible for long-term treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0443252
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. af is known to be present and uninterrupted for more than 12 months prior to randomization. however, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible.
Description

uninterrupted and present AF

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C3843614
2. reversible cause of af such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication.
Description

reversible cause of AF

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0205343
UMLS CUI [2]
C0155679
UMLS CUI [3]
C0034065
UMLS CUI [4]
C0020550
UMLS CUI [5]
C0001969
3. af occurring and not persisting beyond 10 days of surgery or myocardial infarction.
Description

AF not persisting or myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C1518422
UMLS CUI [2]
C0027051
4. reversible cause of chf such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy.
Description

reversible cause of CHF

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018802
UMLS CUI [1,3]
C0205343
UMLS CUI [2,1]
C0155572
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1960445
5. decompensated chf within 48 hours of randomization.
Description

decompensated CHF

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205434
6. antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications.
Description

antiarrhythmic drugs

Data type

boolean

Alias
UMLS CUI [1]
C0003195
7. more than 7 days of amiodarone therapy within the last month prior to randomization.
Description

amiodarone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0002598
8. second or third degree av block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker.
Description

AV block

Data type

boolean

Alias
UMLS CUI [1]
C0004245
UMLS CUI [2]
C0541782
UMLS CUI [3]
C1821417
9. history of drug-induced torsades de pointes or congenital long qt syndrome.
Description

drug-induced torsades de pointes or congenital long qt syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0040479
UMLS CUI [1,2]
C0458082
UMLS CUI [2]
C1141890
10. prior av nodal ablation or maze surgery.
Description

AV nodal ablation or maze surgery

Data type

boolean

Alias
UMLS CUI [1]
C3275044
UMLS CUI [2]
C3272262
11. probable cardiac transplantation in the next 6 months.
Description

probable cardiac transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0332148
12. chronic renal failure requiring dialysis.
Description

chronic renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0011946
13. women of child-bearing potential and not on a reliable method of birth control.
Description

contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C1999124
14. geographic or social factors, drug or alcohol abuse making follow-up or compliance difficult.
Description

compliance factors

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0814423
UMLS CUI [1,4]
C0442527
UMLS CUI [2]
C0038586
15. other noncardiovascular medical condition (such as cancer) making 1 year survival unlikely.
Description

medical condition making survival unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C2348568
16. less than 18 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Atrial Fibrillation NCT00597077

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
left ventricular ejection fraction
Item
1. left ventricular ejection fraction </=35% as measured by nuclear imaging, echocardiography, or cardiac angiography within 6 months preceding enrollment. if the patient has had a myocardial infarction or heart surgery during this period, the ejection fraction must be remeasured.
boolean
symptomatic CHF
Item
2. symptomatic CHF (nyha class ii-iv) at some time during the 6 months before randomization, despite therapy with an ace inhibitor (however, patients who do not tolerate an ace inhibitor are eligible). asymptomatic patients (nyha class i) with either a prior hospitalization for chf during the 6 months before randomization or with a left ventricular ejection fraction of </=25% are also eligible.
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0018802 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4])
AF
Item
3. history of significant AF, defined as either: 1. one episode lasting >/=6 hours (duration of af will be determined by history), within the past 6 months with electrocardiographic confirmation; or 2. an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for af.
boolean
C0004238 (UMLS CUI [1])
eligible for long-term treatment
Item
4. in the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of af.
boolean
C0013893 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
uninterrupted and present AF
Item
1. af is known to be present and uninterrupted for more than 12 months prior to randomization. however, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible.
boolean
C0004238 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C3843614 (UMLS CUI [2,2])
reversible cause of AF
Item
2. reversible cause of af such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication.
boolean
C0015127 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0155679 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0001969 (UMLS CUI [5])
AF not persisting or myocardial infarction
Item
3. af occurring and not persisting beyond 10 days of surgery or myocardial infarction.
boolean
C0004238 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
reversible cause of CHF
Item
4. reversible cause of chf such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy.
boolean
C0015127 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0155572 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1960445 (UMLS CUI [3])
decompensated CHF
Item
5. decompensated chf within 48 hours of randomization.
boolean
C0018802 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
antiarrhythmic drugs
Item
6. antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications.
boolean
C0003195 (UMLS CUI [1])
amiodarone therapy
Item
7. more than 7 days of amiodarone therapy within the last month prior to randomization.
boolean
C0002598 (UMLS CUI [1])
AV block
Item
8. second or third degree av block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker.
boolean
C0004245 (UMLS CUI [1])
C0541782 (UMLS CUI [2])
C1821417 (UMLS CUI [3])
drug-induced torsades de pointes or congenital long qt syndrome
Item
9. history of drug-induced torsades de pointes or congenital long qt syndrome.
boolean
C0040479 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
AV nodal ablation or maze surgery
Item
10. prior av nodal ablation or maze surgery.
boolean
C3275044 (UMLS CUI [1])
C3272262 (UMLS CUI [2])
probable cardiac transplantation
Item
11. probable cardiac transplantation in the next 6 months.
boolean
C0018823 (UMLS CUI [1,1])
C0332148 (UMLS CUI [1,2])
chronic renal failure
Item
12. chronic renal failure requiring dialysis.
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
contraceptive use
Item
13. women of child-bearing potential and not on a reliable method of birth control.
boolean
C1999124 (UMLS CUI [1])
compliance factors
Item
14. geographic or social factors, drug or alcohol abuse making follow-up or compliance difficult.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0814423 (UMLS CUI [1,3])
C0442527 (UMLS CUI [1,4])
C0038586 (UMLS CUI [2])
medical condition making survival unlikely
Item
15. other noncardiovascular medical condition (such as cancer) making 1 year survival unlikely.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
age
Item
16. less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
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