ID

28724

Beschreibung

Optical Coherence Tomography in Long Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT01133925

Link

https://clinicaltrials.gov/show/NCT01133925

Stichworte

Versionen (1)
  1. 29.01.18 29.01.18 -
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See clinicaltrials.gov

Hochgeladen am

29. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT01133925

Englisch

Eligibility Coronary Artery Disease NCT01133925

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia)
Beschreibung

Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive | Electrocardiographic changes Reversible Consistent with Ischemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0340291
UMLS CUI [5,1]
C0039593
UMLS CUI [5,2]
C0205245
UMLS CUI [5,3]
C1514241
UMLS CUI [6,1]
C0855329
UMLS CUI [6,2]
C0205343
UMLS CUI [6,3]
C0332290
UMLS CUI [6,4]
C0022116
native coronary artery disease with >75% diameter stenosis (no prior stent implant, no prior brachytherapy)
Beschreibung

Coronary Artery Disease Native | Percent Diameter Stenosis Measurement | Previous stent placement Absent | Brachytherapy Previous Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0302891
UMLS CUI [2]
C3897965
UMLS CUI [3,1]
C2114504
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0006098
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C0332197
lesion length > 20 mm
Beschreibung

Lesion Length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1444754
vessel size between 2.5 and 3.5 mm
Beschreibung

Vessel Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C0456389
multiple, overlapped endeavor resolute stents placement (intention to overlap > 4 mm).
Beschreibung

Placement of stent multiple overlapping

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0185027
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
left main coronary artery disease
Beschreibung

Left main coronary artery disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1299433
lesions in coronary artery bypass grafts
Beschreibung

Lesion Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0010055
acute myocardial infarction
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
killip class iv
Beschreibung

Killip Class

Datentyp

boolean

Alias
UMLS CUI [1]
C1881332
recent major bleeding (6 months)
Beschreibung

Hemorrhage Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
renal failure with creatinine value > 2.5 mg/dl
Beschreibung

Kidney Failure | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
left ventricular global ejection fraction ≤ 30%.
Beschreibung

Left ventricular ejection fraction Global

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C2348867
allergy to aspirin and or clopidogrel/ticlopidine
Beschreibung

Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
patient in anticoagulant therapy
Beschreibung

Anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
no suitable anatomy for oct scan: (only ostial location, very tortuous anatomy, very distal or large vessels [> 3.5 mm in diameter])
Beschreibung

Anatomy Inappropriate Optical Coherence Tomography | Location Ostium only | Anatomy Tortuous Very | Vessel Distal Very | Vessel Large Very | Vessel Diameter Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700276
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0920367
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0444567
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0700276
UMLS CUI [3,2]
C4068863
UMLS CUI [3,3]
C0442824
UMLS CUI [4,1]
C0005847
UMLS CUI [4,2]
C0205108
UMLS CUI [4,3]
C0442824
UMLS CUI [5,1]
C0005847
UMLS CUI [5,2]
C0549177
UMLS CUI [5,3]
C0442824
UMLS CUI [6,1]
C0005847
UMLS CUI [6,2]
C1301886
UMLS CUI [6,3]
C0456389
target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) < 9 months prior to index procedure
Beschreibung

Target Lesion Location Vessel Epicardial Major | Target Lesion Location Side Branch | Percutaneous Coronary Intervention | Angioplasty, Balloon | Cutting balloon angioplasty | Atherectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0442016
UMLS CUI [1,5]
C0205164
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0441987
UMLS CUI [2,4]
C1253959
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0002996
UMLS CUI [5]
C1269809
UMLS CUI [6]
C0162513
target lesion restenotic from previous stent implantation
Beschreibung

Target Lesion Restenosis Due to Previous stent placement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0333186
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C2114504
any lesion (target or non-target) that has been previously treated with brachytherapy
Beschreibung

Brachytherapy Lesion Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1552551
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01133925

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive | Electrocardiographic changes Reversible Consistent with Ischemia
Item
patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia)
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0039593 (UMLS CUI [5,1])
C0205245 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
C0855329 (UMLS CUI [6,1])
C0205343 (UMLS CUI [6,2])
C0332290 (UMLS CUI [6,3])
C0022116 (UMLS CUI [6,4])
Coronary Artery Disease Native | Percent Diameter Stenosis Measurement | Previous stent placement Absent | Brachytherapy Previous Absent
Item
native coronary artery disease with >75% diameter stenosis (no prior stent implant, no prior brachytherapy)
boolean
C1956346 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C3897965 (UMLS CUI [2])
C2114504 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006098 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Lesion Length
Item
lesion length > 20 mm
boolean
C0221198 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Vessel Size
Item
vessel size between 2.5 and 3.5 mm
boolean
C0005847 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Placement of stent multiple overlapping
Item
multiple, overlapped endeavor resolute stents placement (intention to overlap > 4 mm).
boolean
C0522776 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0185027 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Left main coronary artery disease
Item
left main coronary artery disease
boolean
C1299433 (UMLS CUI [1])
Lesion Coronary Artery Bypass Surgery
Item
lesions in coronary artery bypass grafts
boolean
C0221198 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Myocardial Infarction
Item
acute myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Killip Class
Item
killip class iv
boolean
C1881332 (UMLS CUI [1])
Hemorrhage Major
Item
recent major bleeding (6 months)
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Kidney Failure | Creatinine measurement, serum
Item
renal failure with creatinine value > 2.5 mg/dl
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Left ventricular ejection fraction Global
Item
left ventricular global ejection fraction ≤ 30%.
boolean
C0428772 (UMLS CUI [1,1])
C2348867 (UMLS CUI [1,2])
Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine
Item
allergy to aspirin and or clopidogrel/ticlopidine
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
Anticoagulant therapy
Item
patient in anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Anatomy Inappropriate Optical Coherence Tomography | Location Ostium only | Anatomy Tortuous Very | Vessel Distal Very | Vessel Large Very | Vessel Diameter Size
Item
no suitable anatomy for oct scan: (only ostial location, very tortuous anatomy, very distal or large vessels [> 3.5 mm in diameter])
boolean
C0700276 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C0444567 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0700276 (UMLS CUI [3,1])
C4068863 (UMLS CUI [3,2])
C0442824 (UMLS CUI [3,3])
C0005847 (UMLS CUI [4,1])
C0205108 (UMLS CUI [4,2])
C0442824 (UMLS CUI [4,3])
C0005847 (UMLS CUI [5,1])
C0549177 (UMLS CUI [5,2])
C0442824 (UMLS CUI [5,3])
C0005847 (UMLS CUI [6,1])
C1301886 (UMLS CUI [6,2])
C0456389 (UMLS CUI [6,3])
Target Lesion Location Vessel Epicardial Major | Target Lesion Location Side Branch | Percutaneous Coronary Intervention | Angioplasty, Balloon | Cutting balloon angioplasty | Atherectomy
Item
target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) < 9 months prior to index procedure
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0442016 (UMLS CUI [1,4])
C0205164 (UMLS CUI [1,5])
C2986546 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0441987 (UMLS CUI [2,3])
C1253959 (UMLS CUI [2,4])
C1532338 (UMLS CUI [3])
C0002996 (UMLS CUI [4])
C1269809 (UMLS CUI [5])
C0162513 (UMLS CUI [6])
Target Lesion Restenosis Due to Previous stent placement
Item
target lesion restenotic from previous stent implantation
boolean
C2986546 (UMLS CUI [1,1])
C0333186 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C2114504 (UMLS CUI [1,4])
Brachytherapy Lesion Any
Item
any lesion (target or non-target) that has been previously treated with brachytherapy
boolean
C0006098 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
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