Information:
Fel:
ID
13789
Beskrivning
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED); ODM derived from: https://clinicaltrials.gov/show/NCT01422616
Länk
https://clinicaltrials.gov/show/NCT01422616
Nyckelord
Versioner (1)
- 2016-03-06 2016-03-06 -
Uppladdad den
6 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Ischemic Stroke NCT01422616
Eligibility Ischemic Stroke NCT01422616
- StudyEvent: Eligibility
Similar models
Eligibility Ischemic Stroke NCT01422616
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age
Item
adult (age ≥18 years)
boolean
C0001779 (UMLS CUI [1])
brain imaging; ischaemic stroke
Item
a clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
boolean
C0203860 (UMLS CUI [1])
C0948008 (UMLS CUI [2])
C0948008 (UMLS CUI [2])
therapy ischaemic stroke
Item
able to receive treatment within 4.5 hours after the definite time of onset of symptoms
boolean
C0087111 (UMLS CUI [1,1])
C0948008 (UMLS CUI [1,2])
C0948008 (UMLS CUI [1,2])
systolic bp
Item
have a systolic bp ≤185 mmhg
boolean
C0871470 (UMLS CUI [1])
informed consent
Item
provide informed consent (or via an appropriate proxy, according to local requirements)
boolean
C0021430 (UMLS CUI [1])
recombinant tissue plasminogen activator
Item
specific criteria for arm [a] of low-dose vs standard-dose rtpa:
boolean
C1328116 (UMLS CUI [1])
recombinant tissue plasminogen activator
Item
able to receive either low-dose or standard-dose rtpa
boolean
C1328116 (UMLS CUI [1])
therapy Blood Pressure
Item
specific criteria for arm [b] of intensive bp lowering vs guideline recommended bp control
boolean
C0087111 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,2])
thrombolysis
Item
patient will or has received thrombolysis treatment with rtpa, either randomised dose within the trial or physician decided dose rtpa outside of the trial
boolean
C0040044 (UMLS CUI [1])
systolic bp
Item
sustained elevated systolic bp level, defined as 2 readings 150 mmhg
boolean
C0871470 (UMLS CUI [1])
therapy Blood Pressure
Item
able to commence intensive bp lowering treatment within 6 hours of stroke onset
boolean
C0087111 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,2])
therapy Blood Pressure
Item
able to receive either immediate intensive bp lowering or conservative bp management
boolean
C0087111 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,2])
dementia; death
Item
unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset.
boolean
C0497327 (UMLS CUI [1])
C1306577 (UMLS CUI [2])
C1306577 (UMLS CUI [2])
Compliance behavior Limited Comorbidity
Item
other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mrs scores 2-5)].
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
contraindication rtpa
Item
specific contraindications to rtpa (actilyse) or any of the blood pressure agents to be used.
boolean
C1301624 (UMLS CUI [1,1])
C1328116 (UMLS CUI [1,2])
C1328116 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in another clinical trial involving evaluation of pharmacological agents.
boolean
C2348568 (UMLS CUI [1])
concomitant medication; phosphodiesterase inhibitors; monoamine oxidase inhibitors
Item
need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.
boolean
C2347852 (UMLS CUI [1])
C0031638 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C0031638 (UMLS CUI [2])
C0026457 (UMLS CUI [3])