ID

15038

Description

Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study); ODM derived from: https://clinicaltrials.gov/show/NCT00375063

Link

https://clinicaltrials.gov/show/NCT00375063

Keywords

Versions (1)
  1. 5/12/16 5/12/16 -
Uploaded on

May 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Stenosis NCT00375063

English

Eligibility Coronary Artery Stenosis NCT00375063

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients' age 18 to 80
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
significant lm stenosis (>50%)
Description

severity of coronary stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439793
the target vessel reference diameter 2.5mm.
Description

target vessel diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0456389
concomitant multivessel disease suitable for pci is allowed.
Description

Multivessel disease

Data type

boolean

Alias
UMLS CUI [1]
C0577305
the patient is an acceptable candidate for coronary artery bypass surgery.
Description

bypass surgery

Data type

boolean

Alias
UMLS CUI [1]
C0010055
the patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram.
Description

Agreement for follow-up cardiac catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1522577
the patient written informed consent.
Description

informed consen

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an allergy or contraindication to aspirin, ticlopidine or clopidogrel.
Description

contraindication aspirin, ticlopidine or clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0040207
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0070166
presence of diffuse, significant (>++) calcifications in lm
Description

Calcification

Data type

boolean

Alias
UMLS CUI [1]
C1533591
left ventricular ejection fraction < 35%
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
history of bleeding diathesis or coagulopathy.
Description

Bleeding diathesis or coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
any previous pci or cabg surgery
Description

Pci or cabg surgery

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
acute mi within 48 hours, cardiogenic shock.
Description

Myocardial infarction, cardiogenic shock

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0036980
bail-out stenting of dissected lm during complicated pci.
Description

Stenting of dissected Left Main

Data type

boolean

Alias
UMLS CUI [1,1]
C1395545
UMLS CUI [1,2]
C0687568
the patient suffered a stroke or transient ischemic neurological attack (tia) within 3 months.
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0007787
chronic renal insufficiency.
Description

chronic renal insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0022661
positive pregnancy test.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
any disease that may shorten the life expectancy of the patient.
Description

Life shortening disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0023671
the patient is currently participating in another research study.
Description

participation in other study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Coronary Artery Stenosis NCT00375063

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
the patients' age 18 to 80
boolean
C0001779 (UMLS CUI [1])
severity of coronary stenosis
Item
significant lm stenosis (>50%)
boolean
C0242231 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
target vessel diameter
Item
the target vessel reference diameter 2.5mm.
boolean
C0205042 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Multivessel disease
Item
concomitant multivessel disease suitable for pci is allowed.
boolean
C0577305 (UMLS CUI [1])
bypass surgery
Item
the patient is an acceptable candidate for coronary artery bypass surgery.
boolean
C0010055 (UMLS CUI [1])
Agreement for follow-up cardiac catheterization
Item
the patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram.
boolean
C0021430 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
informed consen
Item
the patient written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication aspirin, ticlopidine or clopidogrel
Item
an allergy or contraindication to aspirin, ticlopidine or clopidogrel.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0040207 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
Calcification
Item
presence of diffuse, significant (>++) calcifications in lm
boolean
C1533591 (UMLS CUI [1])
LVEF
Item
left ventricular ejection fraction < 35%
boolean
C0428772 (UMLS CUI [1])
Bleeding diathesis or coagulopathy
Item
history of bleeding diathesis or coagulopathy.
boolean
C0005779 (UMLS CUI [1])
Pci or cabg surgery
Item
any previous pci or cabg surgery
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Myocardial infarction, cardiogenic shock
Item
acute mi within 48 hours, cardiogenic shock.
boolean
C0027051 (UMLS CUI [1,1])
C0036980 (UMLS CUI [1,2])
Stenting of dissected Left Main
Item
bail-out stenting of dissected lm during complicated pci.
boolean
C1395545 (UMLS CUI [1,1])
C0687568 (UMLS CUI [1,2])
ID.15
Item
the patient suffered a stroke or transient ischemic neurological attack (tia) within 3 months.
boolean
C0038454 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
chronic renal insufficiency
Item
chronic renal insufficiency.
boolean
C0022661 (UMLS CUI [1])
pregnancy
Item
positive pregnancy test.
boolean
C0032961 (UMLS CUI [1])
Life shortening disease
Item
any disease that may shorten the life expectancy of the patient.
boolean
C0012634 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
participation in other study
Item
the patient is currently participating in another research study.
boolean
C2348568 (UMLS CUI [1])
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