ID

28581

Descripción

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

Palabras clave

Versiones (1)
  1. 22/1/18 22/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00825279

Inglés

Eligibility Coronary Artery Disease NCT00825279

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Informed Consent

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Agreement Examination Control

Tipo de datos

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;
Descripción

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

Tipo de datos

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;
Descripción

Lesion de novo Quantity | Requirement Dilate procedure

Tipo de datos

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
Descripción

Target vessel Diameter Size

Tipo de datos

boolean

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

Exclusion Criteria

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

Childbearing Potential Pregnancy Suspicion | Requirement Pregnancy Test

Tipo de datos

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 ,
Descripción

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

Tipo de datos

boolean

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

Lesion Calcified Severe | Exclusion Dilatation preceding

Tipo de datos

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%,
Descripción

Cardiac ejection fraction

Tipo de datos

boolean

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

Percutaneous Coronary Intervention | Drug-Eluting Stent Single

Tipo de datos

boolean

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

Target Lesion Size

Tipo de datos

boolean

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

Blood Coagulation Disorders | Leukopenia | Anemia | Thrombocytopenia

Tipo de datos

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,
Descripción

Paclitaxel allergy | Adverse reactions Paclitaxel

Tipo de datos

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,
Descripción

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

Tipo de datos

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,
Descripción

Duodenal Ulcer | Gastric ulcer

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

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

Left main coronary artery disease Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1299433
UMLS CUI [1,2]
C0439165
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Similar models

Eligibility Coronary Artery Disease NCT00825279

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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