ID

37483

Description

Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism; ODM derived from: https://clinicaltrials.gov/show/NCT01410396

Link

https://clinicaltrials.gov/show/NCT01410396

Keywords

Versions (1)
  1. 8/1/19 8/1/19 -
Copyright Holder

See clinicaltrials.gov

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August 1, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01410396

English

Eligibility Atrial Fibrillation NCT01410396

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age > 50
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
Description

Ischemic stroke | Transient Ischemic Attack | Brain Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0751955
3. patient does not merit indefinite oral anticoagulation. (patients requiring temporary oac for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not oac).
Description

Patients Inappropriate Oral anticoagulants Indefinite

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0354604
UMLS CUI [1,4]
C3640032
4. stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
Description

Cerebrovascular accident Determination | Stroke, Lacunar | Large vessel Intracranial Atherosclerosis | Large vessel Atherosclerosi Extracranial | Combination

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0521095
UMLS CUI [2]
C3178801
UMLS CUI [3,1]
C0225990
UMLS CUI [3,2]
C0751007
UMLS CUI [4,1]
C0225990
UMLS CUI [4,2]
C0004153
UMLS CUI [4,3]
C0580586
UMLS CUI [5]
C0205195
5. patient has been evaluated with at least a 12 lead ekg and at least one day of in-patient or out-patient cardiac telemetry, with no detection of af or atrial flutter.
Description

Evaluation 12 lead ECG | Cardiac telemetry | Atrial Fibrillation Undetectable | Atrial Flutter Undetectable

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0430456
UMLS CUI [2]
C1096012
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C3827727
UMLS CUI [4,1]
C0004239
UMLS CUI [4,2]
C3827727
6. detection of af or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite oac).
Description

Detection Atrial Fibrillation Changing Prevention strategy | Detection Atrial Flutter Changing Prevention strategy | Oral anticoagulants Indefinite

Data type

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0679716
UMLS CUI [2,1]
C1511790
UMLS CUI [2,2]
C0004239
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0679716
UMLS CUI [3,1]
C0354604
UMLS CUI [3,2]
C3640032
7. patient receives and successfully activates lifestar act device.
Description

Cardiac monitoring Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0150496
UMLS CUI [1,2]
C0205369
8. patient or legally authorized representative signs informed consent.
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known history of af or atrial flutter.
Description

Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
2. patient has defibrillator or pacemaker capable of detecting af.
Description

Defibrillator Detection Atrial Fibrillation | Artificial cardiac pacemaker Detection Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0180307
UMLS CUI [1,2]
C1511790
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C1511790
UMLS CUI [2,3]
C0004238
3. patient has indication for indefinite oac.
Description

Indication Oral anticoagulants Indefinite

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0354604
UMLS CUI [1,3]
C3640032
4. patient has indefinite contra-indication to oac. (patients with temporary ineligibility for oac, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment).
Description

Medical contraindication Indefinite Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3640032
UMLS CUI [1,3]
C0354604
5. stroke due to known cause not listed in inclusion criterion 4.
Description

Cerebrovascular accident Due to Cause | Exception Inclusion criteria Number

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0015127
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C0237753
6. cardioembolic stroke.
Description

Cardioembolic stroke

Data type

boolean

Alias
UMLS CUI [1]
C1531624
7. inability to comply with lifestar act monitoring regimen.
Description

Compliance Lacking Cardiac monitoring Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0150496
UMLS CUI [1,4]
C0205369
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Similar models

Eligibility Atrial Fibrillation NCT01410396

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age > 50
boolean
C0001779 (UMLS CUI [1])
Ischemic stroke | Transient Ischemic Attack | Brain Infarction
Item
2. ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
boolean
C0948008 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0751955 (UMLS CUI [3])
Patients Inappropriate Oral anticoagulants Indefinite
Item
3. patient does not merit indefinite oral anticoagulation. (patients requiring temporary oac for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not oac).
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0354604 (UMLS CUI [1,3])
C3640032 (UMLS CUI [1,4])
Cerebrovascular accident Determination | Stroke, Lacunar | Large vessel Intracranial Atherosclerosis | Large vessel Atherosclerosi Extracranial | Combination
Item
4. stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
boolean
C0038454 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C3178801 (UMLS CUI [2])
C0225990 (UMLS CUI [3,1])
C0751007 (UMLS CUI [3,2])
C0225990 (UMLS CUI [4,1])
C0004153 (UMLS CUI [4,2])
C0580586 (UMLS CUI [4,3])
C0205195 (UMLS CUI [5])
Evaluation 12 lead ECG | Cardiac telemetry | Atrial Fibrillation Undetectable | Atrial Flutter Undetectable
Item
5. patient has been evaluated with at least a 12 lead ekg and at least one day of in-patient or out-patient cardiac telemetry, with no detection of af or atrial flutter.
boolean
C1261322 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1096012 (UMLS CUI [2])
C0004238 (UMLS CUI [3,1])
C3827727 (UMLS CUI [3,2])
C0004239 (UMLS CUI [4,1])
C3827727 (UMLS CUI [4,2])
Detection Atrial Fibrillation Changing Prevention strategy | Detection Atrial Flutter Changing Prevention strategy | Oral anticoagulants Indefinite
Item
6. detection of af or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite oac).
boolean
C1511790 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0679716 (UMLS CUI [1,4])
C1511790 (UMLS CUI [2,1])
C0004239 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0679716 (UMLS CUI [2,4])
C0354604 (UMLS CUI [3,1])
C3640032 (UMLS CUI [3,2])
Cardiac monitoring Specified
Item
7. patient receives and successfully activates lifestar act device.
boolean
C0150496 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
8. patient or legally authorized representative signs informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation | Atrial Flutter
Item
1. known history of af or atrial flutter.
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Defibrillator Detection Atrial Fibrillation | Artificial cardiac pacemaker Detection Atrial Fibrillation
Item
2. patient has defibrillator or pacemaker capable of detecting af.
boolean
C0180307 (UMLS CUI [1,1])
C1511790 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2,1])
C1511790 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Indication Oral anticoagulants Indefinite
Item
3. patient has indication for indefinite oac.
boolean
C3146298 (UMLS CUI [1,1])
C0354604 (UMLS CUI [1,2])
C3640032 (UMLS CUI [1,3])
Medical contraindication Indefinite Oral anticoagulants
Item
4. patient has indefinite contra-indication to oac. (patients with temporary ineligibility for oac, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment).
boolean
C1301624 (UMLS CUI [1,1])
C3640032 (UMLS CUI [1,2])
C0354604 (UMLS CUI [1,3])
Cerebrovascular accident Due to Cause | Exception Inclusion criteria Number
Item
5. stroke due to known cause not listed in inclusion criterion 4.
boolean
C0038454 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Cardioembolic stroke
Item
6. cardioembolic stroke.
boolean
C1531624 (UMLS CUI [1])
Compliance Lacking Cardiac monitoring Specified
Item
7. inability to comply with lifestar act monitoring regimen.
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0150496 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
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