ID

28518

Beschrijving

Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00793221

Link

https://clinicaltrials.gov/show/NCT00793221

Trefwoorden

Versies (1)
  1. 21-01-18 21-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00793221

Engels

Eligibility Coronary Artery Disease NCT00793221

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥ 18 year-old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
a total occlusion (timi 0-1) with an estimated time of occlusion > 2 weeks.
Beschrijving

Occlusion Total TIMI grade | Occlusion Time Estimated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1947917
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C4263591
UMLS CUI [2,1]
C1947917
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0750572
symptomatic or silent ischaemia, or viable myocardium.
Beschrijving

Ischemia Symptomatic | Silent myocardial ischemia | Myocardium Viable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0340291
UMLS CUI [3,1]
C0027061
UMLS CUI [3,2]
C0443348
the occlusion is suitable for percutaneous coronary intervention.
Beschrijving

Occlusion suitable Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C1947917
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1532338
the guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.
Beschrijving

Guidewire Crossed Occlusion | Balloon Dilatation Occlusion | Occlusion Dilatation Using Medical Device

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708264
UMLS CUI [1,2]
C0205203
UMLS CUI [1,3]
C1947917
UMLS CUI [2,1]
C0004704
UMLS CUI [2,2]
C1947917
UMLS CUI [3,1]
C1947917
UMLS CUI [3,2]
C1322279
UMLS CUI [3,3]
C1524063
UMLS CUI [3,4]
C0025080
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
Beschrijving

Myocardial Infarction | Area Myocardial Target vessel

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0205146
UMLS CUI [2,2]
C1522564
UMLS CUI [2,3]
C0449618
the lesion can not be crossed with the guidewire and balloon angioplasty.
Beschrijving

Guidewire Across Lesion Unsuccessful | Balloon Angioplasty Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C3272318
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0002996
UMLS CUI [2,2]
C1272705
the vessel has been previously treated percutaneously.
Beschrijving

Prior Therapy Percutaneous Vessel

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0522523
UMLS CUI [1,3]
C0005847
the lesion is not suitable for a 2.25-3.5 coronary stent implantation.
Beschrijving

Lesion Inappropriate Placement of stent in coronary artery | Coronary stent length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0521232
UMLS CUI [2]
C4049808
the patient is not willing to undergo an angiographic follow-up.
Beschrijving

Follow-up Angiography Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0002978
UMLS CUI [1,3]
C0558080
the patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
Beschrijving

Medical contraindication Antiplatelet therapy Prolonged Double | Aspirin | Clopidogrel | Aspirin allergy | Patient need for Anticoagulation Therapy Oral chronic | Operative Surgical Procedure Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1096021
UMLS CUI [1,3]
C0439590
UMLS CUI [1,4]
C0205173
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0004058
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0003281
UMLS CUI [5,3]
C1527415
UMLS CUI [5,4]
C0205191
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C0205539
pregnancy or absence of pregnancy test in women of childbearing age.
Beschrijving

Pregnancy | Childbearing Potential Pregnancy Test Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0332197
chronic renal failure (creatinine plasmatic values > 3.0 mg/dl).
Beschrijving

Kidney Failure, Chronic | Plasma creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C1278055
plasmatic platelet count < 100.000 mm-3 or > 700.000 mm-3.
Beschrijving

Plasma platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C2082381
the patient has a severe non-cardiac disease that limits his/her life expectancy to < 1 year.
Beschrijving

Disease Severe Limiting Life Expectancy | Exception Heart Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
the patient is currently included in other randomized trial.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Coronary Artery Disease NCT00793221

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients ≥ 18 year-old.
boolean
C0001779 (UMLS CUI [1])
Occlusion Total TIMI grade | Occlusion Time Estimated
Item
a total occlusion (timi 0-1) with an estimated time of occlusion > 2 weeks.
boolean
C1947917 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C4263591 (UMLS CUI [1,3])
C1947917 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0750572 (UMLS CUI [2,3])
Ischemia Symptomatic | Silent myocardial ischemia | Myocardium Viable
Item
symptomatic or silent ischaemia, or viable myocardium.
boolean
C0022116 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0340291 (UMLS CUI [2])
C0027061 (UMLS CUI [3,1])
C0443348 (UMLS CUI [3,2])
Occlusion suitable Percutaneous Coronary Intervention
Item
the occlusion is suitable for percutaneous coronary intervention.
boolean
C1947917 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Guidewire Crossed Occlusion | Balloon Dilatation Occlusion | Occlusion Dilatation Using Medical Device
Item
the guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.
boolean
C1708264 (UMLS CUI [1,1])
C0205203 (UMLS CUI [1,2])
C1947917 (UMLS CUI [1,3])
C0004704 (UMLS CUI [2,1])
C1947917 (UMLS CUI [2,2])
C1947917 (UMLS CUI [3,1])
C1322279 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
C0025080 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Area Myocardial Target vessel
Item
acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
boolean
C0027051 (UMLS CUI [1])
C0205146 (UMLS CUI [2,1])
C1522564 (UMLS CUI [2,2])
C0449618 (UMLS CUI [2,3])
Guidewire Across Lesion Unsuccessful | Balloon Angioplasty Unsuccessful
Item
the lesion can not be crossed with the guidewire and balloon angioplasty.
boolean
C3272318 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Prior Therapy Percutaneous Vessel
Item
the vessel has been previously treated percutaneously.
boolean
C1514463 (UMLS CUI [1,1])
C0522523 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
Lesion Inappropriate Placement of stent in coronary artery | Coronary stent length
Item
the lesion is not suitable for a 2.25-3.5 coronary stent implantation.
boolean
C0221198 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0521232 (UMLS CUI [1,3])
C4049808 (UMLS CUI [2])
Follow-up Angiography Unwilling
Item
the patient is not willing to undergo an angiographic follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Medical contraindication Antiplatelet therapy Prolonged Double | Aspirin | Clopidogrel | Aspirin allergy | Patient need for Anticoagulation Therapy Oral chronic | Operative Surgical Procedure Scheduled
Item
the patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
boolean
C1301624 (UMLS CUI [1,1])
C1096021 (UMLS CUI [1,2])
C0439590 (UMLS CUI [1,3])
C0205173 (UMLS CUI [1,4])
C0004057 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0004058 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C0003281 (UMLS CUI [5,2])
C1527415 (UMLS CUI [5,3])
C0205191 (UMLS CUI [5,4])
C0543467 (UMLS CUI [6,1])
C0205539 (UMLS CUI [6,2])
Pregnancy | Childbearing Potential Pregnancy Test Absent
Item
pregnancy or absence of pregnancy test in women of childbearing age.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Kidney Failure, Chronic | Plasma creatinine measurement
Item
chronic renal failure (creatinine plasmatic values > 3.0 mg/dl).
boolean
C0022661 (UMLS CUI [1])
C1278055 (UMLS CUI [2])
Plasma platelet count
Item
plasmatic platelet count < 100.000 mm-3 or > 700.000 mm-3.
boolean
C2082381 (UMLS CUI [1])
Disease Severe Limiting Life Expectancy | Exception Heart Diseases
Item
the patient has a severe non-cardiac disease that limits his/her life expectancy to < 1 year.
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Study Subject Participation Status
Item
the patient is currently included in other randomized trial.
boolean
C2348568 (UMLS CUI [1])
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