ID

28665

Description

Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00997763

Link

https://clinicaltrials.gov/show/NCT00997763

Keywords

Versions (1)
  1. 1/25/18 1/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 25, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Coronary Artery Disease NCT00997763

English

Eligibility Coronary Artery Disease NCT00997763

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetic patients with angina and documented ischemia or patients with documented silent ischemia
Description

Patients Diabetic | Angina Pectoris | Ischemia | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241863
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0022116
UMLS CUI [4]
C0340291
patients who are eligible for intracoronary stenting
Description

Patients eligible Coronary stenting

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0687568
age >18 years, <75 ages
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
de novo lesion
Description

Lesion de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
percent diameter stenosis ≥50%
Description

Percent Diameter Stenosis Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3897965
reference vessel size ≥ 2.5 mm by visual estimation
Description

Reference Vessel Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0456389
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of bleeding diathesis or coagulopathy
Description

Bleeding tendency | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
pregnant state
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
known hypersensitivity or contra-indication to contrast agent and heparin
Description

Contrast media allergy | Heparin allergy | Medical contraindication Contrast Media | Medical contraindication Heparin

Data type

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0009924
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0019134
limited life-expectancy (less than 1 year)
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
acute st elevation myocardial infarction on admission
Description

ST segment elevation myocardial infarction On admission

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0457453
characteristics of lesion
Description

Lesion Characteristics

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521970
1. left main disease
Description

Left main coronary artery disease

Data type

boolean

Alias
UMLS CUI [1]
C1299433
2. in-stent restenosis
Description

In Stent restenosis

Data type

boolean

Alias
UMLS CUI [1]
C3272317
3. graft vessels
Description

Graft Vessels

Data type

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C0005847
hematological disease (neutropenia <3000/mm3, thrombocytopenia <100,000/mm3)
Description

Hematological Disease | Neutropenia | Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0027947
UMLS CUI [3]
C0040034
hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal
Description

Liver Dysfunction | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0235996
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
renal dysfunction, creatinine ≥ 2.0mg/dl
Description

Renal dysfunction | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
contraindication to aspirin, clopidogrel or cilostazol
Description

Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Cilostazol

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0055729
left ventricular ejection fraction <30%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0205257
non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Description

Comorbidity Protocol Compliance Unable | Exception Heart Diseases | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
Back to the top of the page

Similar models

Eligibility Coronary Artery Disease NCT00997763

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Diabetic | Angina Pectoris | Ischemia | Silent myocardial ischemia
Item
diabetic patients with angina and documented ischemia or patients with documented silent ischemia
boolean
C0030705 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0022116 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Patients eligible Coronary stenting
Item
patients who are eligible for intracoronary stenting
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0687568 (UMLS CUI [1,3])
Age
Item
age >18 years, <75 ages
boolean
C0001779 (UMLS CUI [1])
Lesion de novo
Item
de novo lesion
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Percent Diameter Stenosis Measurement
Item
percent diameter stenosis ≥50%
boolean
C3897965 (UMLS CUI [1])
Reference Vessel Size
Item
reference vessel size ≥ 2.5 mm by visual estimation
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Bleeding tendency | Blood Coagulation Disorders
Item
history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Pregnancy
Item
pregnant state
boolean
C0032961 (UMLS CUI [1])
Contrast media allergy | Heparin allergy | Medical contraindication Contrast Media | Medical contraindication Heparin
Item
known hypersensitivity or contra-indication to contrast agent and heparin
boolean
C0570562 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0009924 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
Life Expectancy
Item
limited life-expectancy (less than 1 year)
boolean
C0023671 (UMLS CUI [1])
ST segment elevation myocardial infarction On admission
Item
acute st elevation myocardial infarction on admission
boolean
C1536220 (UMLS CUI [1,1])
C0457453 (UMLS CUI [1,2])
Lesion Characteristics
Item
characteristics of lesion
boolean
C0221198 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Left main coronary artery disease
Item
1. left main disease
boolean
C1299433 (UMLS CUI [1])
In Stent restenosis
Item
2. in-stent restenosis
boolean
C3272317 (UMLS CUI [1])
Graft Vessels
Item
3. graft vessels
boolean
C0332835 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
Hematological Disease | Neutropenia | Thrombocytopenia
Item
hematological disease (neutropenia <3000/mm3, thrombocytopenia <100,000/mm3)
boolean
C0018939 (UMLS CUI [1])
C0027947 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
Liver Dysfunction | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal
boolean
C0086565 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction, creatinine ≥ 2.0mg/dl
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Cilostazol
Item
contraindication to aspirin, clopidogrel or cilostazol
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0055729 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction <30%
boolean
C0428772 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete
Item
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
Comorbidity Protocol Compliance Unable | Exception Heart Diseases | Life Expectancy
Item
non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
boolean
C0009488 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial