ID

42347

Beskrivning

Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT01855035

Länk

https://clinicaltrials.gov/show/NCT01855035

Nyckelord

Versioner (1)
  1. 2021-06-21 2021-06-21 -
Rättsinnehavare

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Uppladdad den

21 juni 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Stroke NCT01855035

Engelsk

Eligibility Stroke NCT01855035

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT01855035
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
Beskrivning

Clinical diagnosis of a stroke with or without corresponding lesion on brain imaging.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948008
UMLS CUI [1,2]
C0332140
UMLS CUI [1,3]
C0011923
UMLS CUI [1,4]
C1519941
UMLS CUI [1,5]
C0332185
UMLS CUI [2,1]
C0948008
UMLS CUI [2,2]
C0332140
UMLS CUI [2,3]
C0011923
UMLS CUI [2,4]
C1519941
UMLS CUI [2,5]
C0332197
UMLS CUI [2,6]
C0332185
stroke symptoms started ≤ 7 days ago.
Beskrivning

Stroke symptoms recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332185
age ≥ 60 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
modified rankin scale ≤ 2 (prior to index event).
Beskrivning

Modified rankin scale

Datatyp

boolean

Alias
UMLS CUI [1]
C2984908
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ecg.
Beskrivning

Medical history of atrial fibrillation | Medical history of flutter | Atrial fibrillation on admission ecg | Atrial flutter on admission ecg

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0004239
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C1623258
UMLS CUI [3,3]
C0030673
UMLS CUI [4,1]
C0004239
UMLS CUI [4,2]
C1623258
UMLS CUI [4,3]
C0030673
indication for oral anticoagulation at randomisation.
Beskrivning

Oral anticoagulation indication at randomisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0034656
absolute contra-indication against oral anticoagulation at randomisation.
Beskrivning

Absolute contra-indication against oral anticoagulation at randomisation.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0205344
UMLS CUI [1,4]
C0034656
intracerebral bleeding in medical history.
Beskrivning

Medical history of intracerebral bleeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2937358
patient scheduled for holter-ecg or cardiac event-recording monitoring ≥ 48 hours.
Beskrivning

Holter-ecg planned or cardiac event-recording planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C2825163
UMLS CUI [2,2]
C1301732
significant carotid artery or vertebral artery stenosis > 50% (nascet classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
Beskrivning

Significant carotid artery stenosis, NASCET classification | Significant vertebral artery stenosis | Significant intracranial stenosis suspicious of atherosclerotic origin | Acute arterial dissection explanatory of stroke

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C3266727
UMLS CUI [2,1]
C0265103
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C1504438
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0750493
UMLS CUI [3,4]
C2936350
UMLS CUI [4,1]
C0338585
UMLS CUI [4,2]
C0681841
UMLS CUI [4,3]
C0038454
implanted pacemaker device or cardioverter/defibrillator.
Beskrivning

Implanted pacemaker device | Implanted cardioverter/defibrillator.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0848753
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C0810516
UMLS CUI [2,2]
C0150312
life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer).
Beskrivning

Life expectancy decreased for reason other than stroke

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C3840932
concomitant participation in other controlled randomised trial.
Beskrivning

Concomitant participation in other controlled randomised trial.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
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Similar models

Eligibility Stroke NCT01855035

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT01855035
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical diagnosis of a stroke with or without corresponding lesion on brain imaging.
Item
recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
boolean
C0948008 (UMLS CUI [1,1])
C0332140 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1519941 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,5])
C0948008 (UMLS CUI [2,1])
C0332140 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C1519941 (UMLS CUI [2,4])
C0332197 (UMLS CUI [2,5])
C0332185 (UMLS CUI [2,6])
Stroke symptoms recent
Item
stroke symptoms started ≤ 7 days ago.
boolean
C0038454 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Age
Item
age ≥ 60 years.
boolean
C0001779 (UMLS CUI [1])
Modified rankin scale
Item
modified rankin scale ≤ 2 (prior to index event).
boolean
C2984908 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical history of atrial fibrillation | Medical history of flutter | Atrial fibrillation on admission ecg | Atrial flutter on admission ecg
Item
known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ecg.
boolean
C0262926 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0004239 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
C0030673 (UMLS CUI [3,3])
C0004239 (UMLS CUI [4,1])
C1623258 (UMLS CUI [4,2])
C0030673 (UMLS CUI [4,3])
Oral anticoagulation indication at randomisation
Item
indication for oral anticoagulation at randomisation.
boolean
C0354604 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Absolute contra-indication against oral anticoagulation at randomisation.
Item
absolute contra-indication against oral anticoagulation at randomisation.
boolean
C0003281 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0205344 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
Medical history of intracerebral bleeding
Item
intracerebral bleeding in medical history.
boolean
C0262926 (UMLS CUI [1,1])
C2937358 (UMLS CUI [1,2])
Holter-ecg planned or cardiac event-recording planned
Item
patient scheduled for holter-ecg or cardiac event-recording monitoring ≥ 48 hours.
boolean
C0013801 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2825163 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Significant carotid artery stenosis, NASCET classification | Significant vertebral artery stenosis | Significant intracranial stenosis suspicious of atherosclerotic origin | Acute arterial dissection explanatory of stroke
Item
significant carotid artery or vertebral artery stenosis > 50% (nascet classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
boolean
C0007282 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3266727 (UMLS CUI [1,3])
C0265103 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C1504438 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
C2936350 (UMLS CUI [3,4])
C0338585 (UMLS CUI [4,1])
C0681841 (UMLS CUI [4,2])
C0038454 (UMLS CUI [4,3])
Implanted pacemaker device | Implanted cardioverter/defibrillator.
Item
implanted pacemaker device or cardioverter/defibrillator.
boolean
C0848753 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0810516 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Life expectancy decreased for reason other than stroke
Item
life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer).
boolean
C0023671 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
Concomitant participation in other controlled randomised trial.
Item
concomitant participation in other controlled randomised trial.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
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