ID

39132

Description

Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01120405

Link

https://clinicaltrials.gov/show/NCT01120405

Keywords

Versions (1)
  1. 12/4/19 12/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Elevated Cardiac Risk NCT01120405

English

Eligibility Elevated Cardiac Risk NCT01120405

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
Description

Vascular Surgical Procedure atherosclerotic elective Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0042381
UMLS CUI [1,2]
C0333482
UMLS CUI [1,3]
C0439608
UMLS CUI [1,4]
C0205539
cardiac ischaemic risk supported by:
Description

At risk Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0151744
history of myocardial infarction older than 1 month and/or
Description

Myocardial Infarction Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0872146
documented stable angina (asymptomatic ± medical treatment) and/or
Description

Stable angina Asymptomatic | Treatment | Treatment Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0340288
UMLS CUI [1,2]
C0231221
UMLS CUI [2]
C0087111
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
history of coronary revascularisation, and/or
Description

Coronary revascularisation

Data type

boolean

Alias
UMLS CUI [1]
C0877341
surgical risk index ("lee" index) ≥ 3.
Description

Revised cardiac risk index

Data type

boolean

Alias
UMLS CUI [1]
C3164217
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable angina within the last 30 days,
Description

Unstable Angina Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0332185
non controlled arterial hypertension .
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
severe cardiac heart failure (nyha iv)
Description

Heart failure Severe New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
severe chronic obstructive pulmonary disease
Description

Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0730607
patient already randomized in another ongoing clinical trial
Description

Study Subject Participation Status | Clinical Trial, Randomized

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0206034
patient with recent myocardial infarction (m.i) (less than one month )
Description

Myocardial Infarction Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
patient already included in a clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
history of hypersensitivity to study drugs( i.e xenon, propofol, sevoflurane, desflurane, isoflurane)
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Xenon | Propofol allergy | Allergy to sevoflurane | Desflurane allergy | Isoflurane allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0043339
UMLS CUI [3]
C0570632
UMLS CUI [4]
C2711572
UMLS CUI [5]
C0570641
UMLS CUI [6]
C0570639
malignant hyperthermia
Description

Malignant fever

Data type

boolean

Alias
UMLS CUI [1]
C2930828
documented elevated intracranial pressure
Description

Intracranial Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0151740
preeclampsia or eclampsia
Description

Pre-Eclampsia | Eclampsia

Data type

boolean

Alias
UMLS CUI [1]
C0032914
UMLS CUI [2]
C0013537
pregnancy and lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
presumed uncooperativeness or legal incapacity
Description

Uncooperative behavior Suspected | Legal capacity Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0424350
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
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Similar models

Eligibility Elevated Cardiac Risk NCT01120405

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Vascular Surgical Procedure atherosclerotic elective Scheduled
Item
scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
boolean
C0042381 (UMLS CUI [1,1])
C0333482 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
At risk Myocardial Ischemia
Item
cardiac ischaemic risk supported by:
boolean
C1444641 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
Myocardial Infarction Disease length
Item
history of myocardial infarction older than 1 month and/or
boolean
C0027051 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Stable angina Asymptomatic | Treatment | Treatment Absent
Item
documented stable angina (asymptomatic ± medical treatment) and/or
boolean
C0340288 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Coronary revascularisation
Item
history of coronary revascularisation, and/or
boolean
C0877341 (UMLS CUI [1])
Revised cardiac risk index
Item
surgical risk index ("lee" index) ≥ 3.
boolean
C3164217 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unstable Angina Recent
Item
unstable angina within the last 30 days,
boolean
C0002965 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
non controlled arterial hypertension .
boolean
C1868885 (UMLS CUI [1])
Heart failure Severe New York Heart Association Classification
Item
severe cardiac heart failure (nyha iv)
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Severe chronic obstructive pulmonary disease
Item
severe chronic obstructive pulmonary disease
boolean
C0730607 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial, Randomized
Item
patient already randomized in another ongoing clinical trial
boolean
C2348568 (UMLS CUI [1])
C0206034 (UMLS CUI [2])
Myocardial Infarction Recent
Item
patient with recent myocardial infarction (m.i) (less than one month )
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patient already included in a clinical trial
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Xenon | Propofol allergy | Allergy to sevoflurane | Desflurane allergy | Isoflurane allergy
Item
history of hypersensitivity to study drugs( i.e xenon, propofol, sevoflurane, desflurane, isoflurane)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0043339 (UMLS CUI [2,2])
C0570632 (UMLS CUI [3])
C2711572 (UMLS CUI [4])
C0570641 (UMLS CUI [5])
C0570639 (UMLS CUI [6])
Malignant fever
Item
malignant hyperthermia
boolean
C2930828 (UMLS CUI [1])
Intracranial Hypertension
Item
documented elevated intracranial pressure
boolean
C0151740 (UMLS CUI [1])
Pre-Eclampsia | Eclampsia
Item
preeclampsia or eclampsia
boolean
C0032914 (UMLS CUI [1])
C0013537 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Uncooperative behavior Suspected | Legal capacity Lacking
Item
presumed uncooperativeness or legal incapacity
boolean
C0424350 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
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