ID

28665

Beschrijving

Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00997763

Link

https://clinicaltrials.gov/show/NCT00997763

Trefwoorden

Versies (1)
  1. 25-01-18 25-01-18 -
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See clinicaltrials.gov

Geüploaded op

25 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00997763

Engels

Eligibility Coronary Artery Disease NCT00997763

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetic patients with angina and documented ischemia or patients with documented silent ischemia
Beschrijving

Patients Diabetic | Angina Pectoris | Ischemia | Silent myocardial ischemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241863
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0022116
UMLS CUI [4]
C0340291
patients who are eligible for intracoronary stenting
Beschrijving

Patients eligible Coronary stenting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0687568
age >18 years, <75 ages
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
de novo lesion
Beschrijving

Lesion de novo

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
percent diameter stenosis ≥50%
Beschrijving

Percent Diameter Stenosis Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3897965
reference vessel size ≥ 2.5 mm by visual estimation
Beschrijving

Reference Vessel Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0456389
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of bleeding diathesis or coagulopathy
Beschrijving

Bleeding tendency | Blood Coagulation Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
pregnant state
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
known hypersensitivity or contra-indication to contrast agent and heparin
Beschrijving

Contrast media allergy | Heparin allergy | Medical contraindication Contrast Media | Medical contraindication Heparin

Datatype

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0009924
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0019134
limited life-expectancy (less than 1 year)
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
acute st elevation myocardial infarction on admission
Beschrijving

ST segment elevation myocardial infarction On admission

Datatype

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0457453
characteristics of lesion
Beschrijving

Lesion Characteristics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521970
1. left main disease
Beschrijving

Left main coronary artery disease

Datatype

boolean

Alias
UMLS CUI [1]
C1299433
2. in-stent restenosis
Beschrijving

In Stent restenosis

Datatype

boolean

Alias
UMLS CUI [1]
C3272317
3. graft vessels
Beschrijving

Graft Vessels

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C0005847
hematological disease (neutropenia <3000/mm3, thrombocytopenia <100,000/mm3)
Beschrijving

Hematological Disease | Neutropenia | Thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0027947
UMLS CUI [3]
C0040034
hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal
Beschrijving

Liver Dysfunction | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0235996
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
renal dysfunction, creatinine ≥ 2.0mg/dl
Beschrijving

Renal dysfunction | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
contraindication to aspirin, clopidogrel or cilostazol
Beschrijving

Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Cilostazol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0055729
left ventricular ejection fraction <30%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0205257
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).
Beschrijving

Comorbidity Protocol Compliance Unable | Exception Heart Diseases | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
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Similar models

Eligibility Coronary Artery Disease NCT00997763

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Patients Diabetic | Angina Pectoris | Ischemia | Silent myocardial ischemia
Item
diabetic patients with angina and documented ischemia or patients with documented silent ischemia
boolean
C0030705 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0022116 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Patients eligible Coronary stenting
Item
patients who are eligible for intracoronary stenting
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0687568 (UMLS CUI [1,3])
Age
Item
age >18 years, <75 ages
boolean
C0001779 (UMLS CUI [1])
Lesion de novo
Item
de novo lesion
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Percent Diameter Stenosis Measurement
Item
percent diameter stenosis ≥50%
boolean
C3897965 (UMLS CUI [1])
Reference Vessel Size
Item
reference vessel size ≥ 2.5 mm by visual estimation
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Bleeding tendency | Blood Coagulation Disorders
Item
history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Pregnancy
Item
pregnant state
boolean
C0032961 (UMLS CUI [1])
Contrast media allergy | Heparin allergy | Medical contraindication Contrast Media | Medical contraindication Heparin
Item
known hypersensitivity or contra-indication to contrast agent and heparin
boolean
C0570562 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0009924 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
Life Expectancy
Item
limited life-expectancy (less than 1 year)
boolean
C0023671 (UMLS CUI [1])
ST segment elevation myocardial infarction On admission
Item
acute st elevation myocardial infarction on admission
boolean
C1536220 (UMLS CUI [1,1])
C0457453 (UMLS CUI [1,2])
Lesion Characteristics
Item
characteristics of lesion
boolean
C0221198 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Left main coronary artery disease
Item
1. left main disease
boolean
C1299433 (UMLS CUI [1])
In Stent restenosis
Item
2. in-stent restenosis
boolean
C3272317 (UMLS CUI [1])
Graft Vessels
Item
3. graft vessels
boolean
C0332835 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
Hematological Disease | Neutropenia | Thrombocytopenia
Item
hematological disease (neutropenia <3000/mm3, thrombocytopenia <100,000/mm3)
boolean
C0018939 (UMLS CUI [1])
C0027947 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
Liver Dysfunction | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal
boolean
C0086565 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction, creatinine ≥ 2.0mg/dl
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Cilostazol
Item
contraindication to aspirin, clopidogrel or cilostazol
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0055729 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction <30%
boolean
C0428772 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete
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])
C2986535 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
Comorbidity Protocol Compliance Unable | Exception Heart Diseases | 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])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
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