ID

23982

Beschrijving

3 Limus Agent Eluting Stents With Different Polymer Coating; ODM derived from: https://clinicaltrials.gov/show/NCT00598676

Link

https://clinicaltrials.gov/show/NCT00598676

Trefwoorden

Versies (1)
  1. 20-07-17 20-07-17 -
Geüploaded op

20 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00598676

Engels

Eligibility Coronary Heart Disease NCT00598676

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels.
Beschrijving

Age | Symptoms Ischemic | Myocardial Ischemia | De novo stenosis Percentage Coronary Vessels Native

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0475224
UMLS CUI [3]
C0151744
UMLS CUI [4,1]
C4264488
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0010075
UMLS CUI [4,4]
C0302891
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
in women with childbearing potential a negative pregnancy test is mandatory
Beschrijving

Childbearing Potential Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
target lesion located in the left main trunk.
Beschrijving

Target Lesion Within Trunk of left coronary artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0920980
target lesion located in the bypass graft.
Beschrijving

Target Lesion Within Bypass graft

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0185098
in-stent restenosis.
Beschrijving

In-stent arterial restenosis

Datatype

boolean

Alias
UMLS CUI [1]
C1739098
cardiogenic shock.
Beschrijving

Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1]
C0036980
malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Beschrijving

Malignant Neoplasms Life Expectancy Limited | Comorbidity Life Expectancy Limited | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Malignant Neoplasms Protocol Compliance Lacking | Comorbidity Protocol Compliance Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0023671
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0023671
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0030286
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0332268
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0332268
known allergy to the study medications: clopidogrel, rapamycin, everolimus, stainless steel or cobalt chrome.
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity everolimus | Hypersensitivity Stainless Steel | Hypersensitivity Cobalt Chrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0072980
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0541315
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0038126
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0008576
inability to take clopidogrel for at least 6 months.
Beschrijving

Unable to take clopidogrel

Datatype

boolean

Alias
UMLS CUI [1,1]
C4074979
UMLS CUI [1,2]
C0070166
pregnancy (present, suspected or planned) or positive pregnancy test.
Beschrijving

Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
previous enrollment in this trial.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
patient's inability to fully cooperate with the study protocol
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Coronary Heart Disease NCT00598676

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Symptoms Ischemic | Myocardial Ischemia | De novo stenosis Percentage Coronary Vessels Native
Item
patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels.
boolean
C0001779 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3])
C4264488 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0010075 (UMLS CUI [4,3])
C0302891 (UMLS CUI [4,4])
Informed Consent | Informed Consent Patient Representative
Item
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
in women with childbearing potential a negative pregnancy test is mandatory
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Target Lesion Within Trunk of left coronary artery
Item
target lesion located in the left main trunk.
boolean
C2986546 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0920980 (UMLS CUI [1,3])
Target Lesion Within Bypass graft
Item
target lesion located in the bypass graft.
boolean
C2986546 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0185098 (UMLS CUI [1,3])
In-stent arterial restenosis
Item
in-stent restenosis.
boolean
C1739098 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Malignant Neoplasms Life Expectancy Limited | Comorbidity Life Expectancy Limited | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Malignant Neoplasms Protocol Compliance Lacking | Comorbidity Protocol Compliance Lacking
Item
malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
boolean
C0006826 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0023671 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0030286 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
C0009488 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0332268 (UMLS CUI [7,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity everolimus | Hypersensitivity Stainless Steel | Hypersensitivity Cobalt Chrome
Item
known allergy to the study medications: clopidogrel, rapamycin, everolimus, stainless steel or cobalt chrome.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0038126 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0008576 (UMLS CUI [6,2])
Unable to take clopidogrel
Item
inability to take clopidogrel for at least 6 months.
boolean
C4074979 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive
Item
pregnancy (present, suspected or planned) or positive pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Study Subject Participation Status
Item
previous enrollment in this trial.
boolean
C2348568 (UMLS CUI [1])
Protocol Compliance Unable
Item
patient's inability to fully cooperate with the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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