ID

20394

Beschreibung

Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00418067

Link

https://clinicaltrials.gov/show/NCT00418067

Stichworte

Versionen (1)
  1. 21.02.17 21.02.17 -
Hochgeladen am

21. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00418067

Englisch

Eligibility Coronary Artery Disease NCT00418067

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must be at least 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
significant coronary artery stenosis (>50% by visual estimate)
Beschreibung

Coronary Stenosis Percentage Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0444684
patients with stable (ccs class 1 to 4) or acute coronary syndromes (unstable angina pectoris class ib, ic, iib, iic, iiib, iiic or nstemi) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
Beschreibung

Syndrome Coronary Stable Canadian Cardiovascular Society Grading Scale Class | Acute Coronary Syndrome | Unstable Angina New York Heart Association Classification | non-ST segment elevation myocardial infarction | Atypical chest pain | Myocardial Ischemia | Percutaneous Coronary Intervention Stent Assisted Amenable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C1879987
UMLS CUI [2]
C0948089
UMLS CUI [3,1]
C0002965
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C1276061
UMLS CUI [5]
C0262384
UMLS CUI [6]
C0151744
UMLS CUI [7,1]
C1532338
UMLS CUI [7,2]
C0038257
UMLS CUI [7,3]
C1269765
UMLS CUI [7,4]
C3900053
the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Beschreibung

Protocol Compliance | Clinical Study Follow-up | Clinical Study Follow-up Angiography | Informed Consent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C3274571
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0002978
UMLS CUI [4]
C0021430
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C1274041
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has a known hypersensitivity or contraindication to any of the following medications:
Beschreibung

Hypersensitivity Pharmaceutical Preparations | Medical contraindication Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013227
• heparin, aspirin, both clopidogrel and ticlopidine, sirolimus, paclitaxel, abt 578, stainless steel and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
Beschreibung

Heparin | Aspirin | clopidogrel | Ticlopidine | Sirolimus | Paclitaxel | ABT-578 | Stainless Steel | Contrast Media | Contrast media allergy | Steroids | Diphenhydramine | Exanthema | anaphylaxis reaction to contrast material

Datentyp

boolean

Alias
UMLS CUI [1]
C0019134
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0040207
UMLS CUI [5]
C0072980
UMLS CUI [6]
C0144576
UMLS CUI [7]
C2350862
UMLS CUI [8]
C0038126
UMLS CUI [9]
C0009924
UMLS CUI [10]
C0570562
UMLS CUI [11]
C0038317
UMLS CUI [12]
C0012522
UMLS CUI [13]
C0015230
UMLS CUI [14]
C2215729
female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Planned Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032992
current known current platelet count <100,000 cells/mm3 or hgb <10 g/dl.
Beschreibung

Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0518015
an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 12 months post enrollment.
Beschreibung

Elective Surgical Procedure Planned | Antiplatelet Agents Interrupted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0085826
UMLS CUI [2,2]
C1512900
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).
Beschreibung

Comorbidity Protocol Compliance Unable | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0023671
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
patients who have target lesion of in-stent restenosis at the stented segment of drug-eluting stent (in-stent restenosis of bare metal stent can be included).
Beschreibung

Target Lesion Stent restenosis | Stent restenosis Drug-Eluting Coronary Stents | Stent restenosis Bare metal stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C3272317
UMLS CUI [2,1]
C3272317
UMLS CUI [2,2]
C1262327
UMLS CUI [3,1]
C3272317
UMLS CUI [3,2]
C2825200
patients with ef<30%.
Beschreibung

Ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0489482
patients with cardiogenic shock
Beschreibung

Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
acute stemi patients within symptom onset < 12 hours needing primary angioplasty
Beschreibung

ST segment elevation myocardial infarction Requirement Angioplasty Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0162577
UMLS CUI [1,4]
C0205225
creatinine level > 3.0mg/dl or dependence on dialysis.
Beschreibung

Creatinine measurement, serum | Dependence on renal dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0524376
severe hepatic dysfunction (ast and alt > 3 times upper normal reference values).
Beschreibung

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
patients with left main stem stenosis (>50% by visual estimate)
Beschreibung

left main coronary artery stenosis Percentage Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2062905
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0444684
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00418067

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
the patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Coronary Stenosis Percentage Visual estimation
Item
significant coronary artery stenosis (>50% by visual estimate)
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
Syndrome Coronary Stable Canadian Cardiovascular Society Grading Scale Class | Acute Coronary Syndrome | Unstable Angina New York Heart Association Classification | non-ST segment elevation myocardial infarction | Atypical chest pain | Myocardial Ischemia | Percutaneous Coronary Intervention Stent Assisted Amenable
Item
patients with stable (ccs class 1 to 4) or acute coronary syndromes (unstable angina pectoris class ib, ic, iib, iic, iiib, iiic or nstemi) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
boolean
C0039082 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1879987 (UMLS CUI [1,4])
C0948089 (UMLS CUI [2])
C0002965 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C1276061 (UMLS CUI [4])
C0262384 (UMLS CUI [5])
C0151744 (UMLS CUI [6])
C1532338 (UMLS CUI [7,1])
C0038257 (UMLS CUI [7,2])
C1269765 (UMLS CUI [7,3])
C3900053 (UMLS CUI [7,4])
Protocol Compliance | Clinical Study Follow-up | Clinical Study Follow-up Angiography | Informed Consent | Informed Consent Guardian
Item
the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
boolean
C0525058 (UMLS CUI [1])
C3274571 (UMLS CUI [2])
C3274571 (UMLS CUI [3,1])
C0002978 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
C0021430 (UMLS CUI [5,1])
C1274041 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Pharmaceutical Preparations | Medical contraindication Pharmaceutical Preparations
Item
the patient has a known hypersensitivity or contraindication to any of the following medications:
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Heparin | Aspirin | clopidogrel | Ticlopidine | Sirolimus | Paclitaxel | ABT-578 | Stainless Steel | Contrast Media | Contrast media allergy | Steroids | Diphenhydramine | Exanthema | anaphylaxis reaction to contrast material
Item
• heparin, aspirin, both clopidogrel and ticlopidine, sirolimus, paclitaxel, abt 578, stainless steel and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
boolean
C0019134 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0040207 (UMLS CUI [4])
C0072980 (UMLS CUI [5])
C0144576 (UMLS CUI [6])
C2350862 (UMLS CUI [7])
C0038126 (UMLS CUI [8])
C0009924 (UMLS CUI [9])
C0570562 (UMLS CUI [10])
C0038317 (UMLS CUI [11])
C0012522 (UMLS CUI [12])
C0015230 (UMLS CUI [13])
C2215729 (UMLS CUI [14])
Childbearing Potential Pregnancy test negative | Childbearing Potential Planned Pregnancy
Item
female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032992 (UMLS CUI [2,2])
Platelet Count measurement | Hemoglobin measurement
Item
current known current platelet count <100,000 cells/mm3 or hgb <10 g/dl.
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Elective Surgical Procedure Planned | Antiplatelet Agents Interrupted
Item
an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 12 months post enrollment.
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0085826 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
Comorbidity Protocol Compliance Unable | 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])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
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])
Target Lesion Stent restenosis | Stent restenosis Drug-Eluting Coronary Stents | Stent restenosis Bare metal stent
Item
patients who have target lesion of in-stent restenosis at the stented segment of drug-eluting stent (in-stent restenosis of bare metal stent can be included).
boolean
C2986546 (UMLS CUI [1,1])
C3272317 (UMLS CUI [1,2])
C3272317 (UMLS CUI [2,1])
C1262327 (UMLS CUI [2,2])
C3272317 (UMLS CUI [3,1])
C2825200 (UMLS CUI [3,2])
Ejection fraction
Item
patients with ef<30%.
boolean
C0489482 (UMLS CUI [1])
Shock, Cardiogenic
Item
patients with cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
ST segment elevation myocardial infarction Requirement Angioplasty Primary
Item
acute stemi patients within symptom onset < 12 hours needing primary angioplasty
boolean
C1536220 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0162577 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Creatinine measurement, serum | Dependence on renal dialysis
Item
creatinine level > 3.0mg/dl or dependence on dialysis.
boolean
C0201976 (UMLS CUI [1])
C0524376 (UMLS CUI [2])
Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
severe hepatic dysfunction (ast and alt > 3 times upper normal reference values).
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
left main coronary artery stenosis Percentage Visual estimation
Item
patients with left main stem stenosis (>50% by visual estimate)
boolean
C2062905 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
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