ID

28765

Beskrivning

Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis; ODM derived from: https://clinicaltrials.gov/show/NCT00598533

Länk

https://clinicaltrials.gov/show/NCT00598533

Nyckelord

Versioner (1)
  1. 2018-02-02 2018-02-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00598533

Engelsk

Eligibility Coronary Heart Disease NCT00598533

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

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

Datatyp

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 [5,1]
C1515974
UMLS CUI [5,2]
C0010075
UMLS CUI [5,3]
C0302891
written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

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.
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

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

Exclusion Criteria

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

Target Lesion Location Trunk of left coronary artery Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0920980
UMLS CUI [1,4]
C1542147
target lesion located in the bypass graft.
Beskrivning

Target Lesion Location Bypass graft

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0185098
in-stent restenosis.
Beskrivning

In Stent restenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C3272317
cardiogenic shock.
Beskrivning

Shock, Cardiogenic

Datatyp

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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0023671
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0030286
UMLS CUI [6,2]
C0205082
known allergy to the study medications: clopidogrel, rapamycin, probucol, zotarolimus, stainless steel or cobalt chrome.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity clopidogrel | Hypersensitivity Rapamycin | Probucol allergy | Hypersensitivity zotarolimus | Hypersensitivity Stainless Steel | Hypersensitivity Cobalt Chrome

Datatyp

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]
C0571861
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1700035
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0038126
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0008576
inability to take clopidogrel for at least 6 months.
Beskrivning

Clopidogrel Intake Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C1299582
pregnancy (present, suspected or planned) or positive pregnancy test.
Beskrivning

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

Datatyp

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.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

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

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
Tillbaka till toppen

Similar models

Eligibility Coronary Heart Disease NCT00598533

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Symptoms Ischemic | Myocardial Ischemia | De novo stenosis Percentage | Location 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])
C1515974 (UMLS CUI [5,1])
C0010075 (UMLS CUI [5,2])
C0302891 (UMLS CUI [5,3])
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 Location Trunk of left coronary artery Main
Item
target lesion located in the left main trunk.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0920980 (UMLS CUI [1,3])
C1542147 (UMLS CUI [1,4])
Target Lesion Location Bypass graft
Item
target lesion located in the bypass graft.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0185098 (UMLS CUI [1,3])
In Stent restenosis
Item
in-stent restenosis.
boolean
C3272317 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Malignant Neoplasms Protocol Compliance Unable | Comorbidity Protocol Compliance Unable | Life Expectancy | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe
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])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0023671 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0030286 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity clopidogrel | Hypersensitivity Rapamycin | Probucol allergy | Hypersensitivity zotarolimus | Hypersensitivity Stainless Steel | Hypersensitivity Cobalt Chrome
Item
known allergy to the study medications: clopidogrel, rapamycin, probucol, zotarolimus, 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])
C0571861 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C1700035 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0038126 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0008576 (UMLS CUI [7,2])
Clopidogrel Intake Unable
Item
inability to take clopidogrel for at least 6 months.
boolean
C0070166 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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])
Tillbaka till toppen 

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