ID

28581

Description

A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00825279

Link

https://clinicaltrials.gov/show/NCT00825279

Keywords

Versions (1)
  1. 1/22/18 1/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 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 NCT00825279

English

Eligibility Coronary Artery Disease NCT00825279

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient signing informed consent after receiving extensive written and oral information about the trial,
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
older than 18 years,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
agreement to have a control examination done after six months,
Description

Agreement Examination Control

Data type

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0243148
patients with angina pectoris symptoms (ccs stages i-iv, unstable angina pectoris braunwald b and c) and patients with documented silent ischemia;
Description

Symptoms Angina Pectoris CCS Grading Scale Class | Unstable Angina Other Coding | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0002962
UMLS CUI [1,3]
C1879987
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C3846158
UMLS CUI [3]
C0340291
patients with one or more de novo lesions which all are to be dilated in the same session;
Description

Lesion de novo Quantity | Requirement Dilate procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1322279
target vessel diameter of 2.5 to 4.0 mm
Description

Target vessel Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
Description

Childbearing Potential Pregnancy Suspicion | Requirement Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0242114
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0032976
acute myocardial infarction (q wave or non q wave ) with documented ck levels more than 2 fold higher than the normal values in the preceding 72 hours ,
Description

Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C0582803
UMLS CUI [2]
C0542269
UMLS CUI [3]
C0151576
substantially calcified lesion precluding successful pre dilatation,
Description

Lesion Calcified Severe | Exclusion Dilatation preceding

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C1322279
UMLS CUI [2,3]
C0332152
ejection fraction less than 35%,
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
patient with previous pci with one des,
Description

Percutaneous Coronary Intervention | Drug-Eluting Stent Single

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2,1]
C1322815
UMLS CUI [2,2]
C0205171
target lesion < 2.5 mm
Description

Target Lesion Size

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0456389
coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
Description

Blood Coagulation Disorders | Leukopenia | Anemia | Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0023530
UMLS CUI [3]
C0002871
UMLS CUI [4]
C0040034
allergy, hypersensitivity or adverse reaction to paclitaxel,
Description

Paclitaxel allergy | Adverse reactions Paclitaxel

Data type

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0144576
intolerance to the clopidogrel, ticlopidine or aspirin or unable to receive clopidogrel for one year,
Description

Intolerance to Clopidogrel | Intolerance to Ticlopidine | Intolerance to Aspirin | Clopidogrel Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0070166
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0040207
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0004057
UMLS CUI [4,1]
C0070166
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C1299582
active duodenal or gastric ulcer,
Description

Duodenal Ulcer | Gastric ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0013295
UMLS CUI [2]
C0038358
life expectancy less than 1 year,
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient with lm disease (>50%)
Description

Left main coronary artery disease Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1299433
UMLS CUI [1,2]
C0439165
Back to the top of the page

Similar models

Eligibility Coronary Artery Disease NCT00825279

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patient signing informed consent after receiving extensive written and oral information about the trial,
boolean
C0021430 (UMLS CUI [1])
Age
Item
older than 18 years,
boolean
C0001779 (UMLS CUI [1])
Agreement Examination Control
Item
agreement to have a control examination done after six months,
boolean
C0680240 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,3])
Symptoms Angina Pectoris CCS Grading Scale Class | Unstable Angina Other Coding | Silent myocardial ischemia
Item
patients with angina pectoris symptoms (ccs stages i-iv, unstable angina pectoris braunwald b and c) and patients with documented silent ischemia;
boolean
C1457887 (UMLS CUI [1,1])
C0002962 (UMLS CUI [1,2])
C1879987 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2,1])
C3846158 (UMLS CUI [2,2])
C0340291 (UMLS CUI [3])
Lesion de novo Quantity | Requirement Dilate procedure
Item
patients with one or more de novo lesions which all are to be dilated in the same session;
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C1322279 (UMLS CUI [2,2])
Target vessel Diameter Size
Item
target vessel diameter of 2.5 to 4.0 mm
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Pregnancy Suspicion | Requirement Pregnancy Test
Item
female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0242114 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase
Item
acute myocardial infarction (q wave or non q wave ) with documented ck levels more than 2 fold higher than the normal values in the preceding 72 hours ,
boolean
C0582803 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
Lesion Calcified Severe | Exclusion Dilatation preceding
Item
substantially calcified lesion precluding successful pre dilatation,
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2828389 (UMLS CUI [2,1])
C1322279 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Cardiac ejection fraction
Item
ejection fraction less than 35%,
boolean
C0232174 (UMLS CUI [1])
Percutaneous Coronary Intervention | Drug-Eluting Stent Single
Item
patient with previous pci with one des,
boolean
C1532338 (UMLS CUI [1])
C1322815 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Target Lesion Size
Item
target lesion < 2.5 mm
boolean
C2986546 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Blood Coagulation Disorders | Leukopenia | Anemia | Thrombocytopenia
Item
coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
boolean
C0005779 (UMLS CUI [1])
C0023530 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
C0040034 (UMLS CUI [4])
Paclitaxel allergy | Adverse reactions Paclitaxel
Item
allergy, hypersensitivity or adverse reaction to paclitaxel,
boolean
C0570707 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
Intolerance to Clopidogrel | Intolerance to Ticlopidine | Intolerance to Aspirin | Clopidogrel Receive Unable
Item
intolerance to the clopidogrel, ticlopidine or aspirin or unable to receive clopidogrel for one year,
boolean
C1744706 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0040207 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0004057 (UMLS CUI [3,2])
C0070166 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Duodenal Ulcer | Gastric ulcer
Item
active duodenal or gastric ulcer,
boolean
C0013295 (UMLS CUI [1])
C0038358 (UMLS CUI [2])
Life Expectancy
Item
life expectancy less than 1 year,
boolean
C0023671 (UMLS CUI [1])
Left main coronary artery disease Percentage
Item
patient with lm disease (>50%)
boolean
C1299433 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
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