ID

13789

Descripción

Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED); ODM derived from: https://clinicaltrials.gov/show/NCT01422616

Link

https://clinicaltrials.gov/show/NCT01422616

Palabras clave

Versiones (1)
  1. 6/3/16 6/3/16 -
Subido en

6 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Ischemic Stroke NCT01422616

Inglés

Eligibility Ischemic Stroke NCT01422616

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult (age ≥18 years)
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
a clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
Descripción

brain imaging; ischaemic stroke

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0203860
UMLS CUI [2]
C0948008
able to receive treatment within 4.5 hours after the definite time of onset of symptoms
Descripción

therapy ischaemic stroke

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0948008
have a systolic bp ≤185 mmhg
Descripción

systolic bp

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
provide informed consent (or via an appropriate proxy, according to local requirements)
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
specific criteria for arm [a] of low-dose vs standard-dose rtpa:
Descripción

recombinant tissue plasminogen activator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1328116
able to receive either low-dose or standard-dose rtpa
Descripción

recombinant tissue plasminogen activator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1328116
specific criteria for arm [b] of intensive bp lowering vs guideline recommended bp control
Descripción

therapy Blood Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0005823
patient will or has received thrombolysis treatment with rtpa, either randomised dose within the trial or physician decided dose rtpa outside of the trial
Descripción

thrombolysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040044
sustained elevated systolic bp level, defined as 2 readings 150 mmhg
Descripción

systolic bp

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
able to commence intensive bp lowering treatment within 6 hours of stroke onset
Descripción

therapy Blood Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0005823
able to receive either immediate intensive bp lowering or conservative bp management
Descripción

therapy Blood Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0005823
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset.
Descripción

dementia; death

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C1306577
other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mrs scores 2-5)].
Descripción

Compliance behavior Limited Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
specific contraindications to rtpa (actilyse) or any of the blood pressure agents to be used.
Descripción

contraindication rtpa

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1328116
participation in another clinical trial involving evaluation of pharmacological agents.
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.
Descripción

concomitant medication; phosphodiesterase inhibitors; monoamine oxidase inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0031638
UMLS CUI [3]
C0026457
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Similar models

Eligibility Ischemic Stroke NCT01422616

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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