ID

15023

Beschrijving

Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS); ODM derived from: https://clinicaltrials.gov/show/NCT00232765

Link

https://clinicaltrials.gov/show/NCT00232765

Trefwoorden

  1. 11-05-16 11-05-16 -
Geüploaded op

11 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00232765

Eligibility Coronary Artery Disease NCT00232765

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or non-pregnant female patients minimum 18 years of age
Beschrijving

Gender, pregnancy,age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0001779
2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii) or patients with documented silent ischemia;
Beschrijving

angina pectoris or unstable angina pectoris or silent myocardial ischemia

Datatype

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340291
3. target lesion is 2.50mm and 3.5mm in diameter (visual estimate);
Beschrijving

Ischemia lesion size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0340561
4. target lesion is 15mm and 30mm in length (visual estimate);
Beschrijving

Ischemia lesion size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0340561
5. target lesion stenosis is >50% and <100% (visual estimate);
Beschrijving

Degree of stenosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0449286
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment;
Beschrijving

myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0439793
2. has unstable angina classified as braunwald iii b or c, or is having a peri infarction;
Beschrijving

Unstable angina or Peri Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
3. documented left ventricular ejection fraction 25%;
Beschrijving

LVEF

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
4. impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Beschrijving

Creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
5. target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require treatment;
Beschrijving

Coronary stenosis localisation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0475264

Similar models

Eligibility Coronary Artery Disease NCT00232765

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender, pregnancy,age
Item
1. male or non-pregnant female patients minimum 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
angina pectoris or unstable angina pectoris or silent myocardial ischemia
Item
2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0340291 (UMLS CUI [3])
Ischemia lesion size
Item
3. target lesion is 2.50mm and 3.5mm in diameter (visual estimate);
boolean
C0449453 (UMLS CUI [1,1])
C0340561 (UMLS CUI [1,2])
Ischemia lesion size
Item
4. target lesion is 15mm and 30mm in length (visual estimate);
boolean
C0449453 (UMLS CUI [1,1])
C0340561 (UMLS CUI [1,2])
Degree of stenosis
Item
5. target lesion stenosis is >50% and <100% (visual estimate);
boolean
C1261287 (UMLS CUI [1,1])
C0449286 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
myocardial infarction
Item
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment;
boolean
C0027051 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Unstable angina or Peri Infarction
Item
2. has unstable angina classified as braunwald iii b or c, or is having a peri infarction;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
LVEF
Item
3. documented left ventricular ejection fraction 25%;
boolean
C0428772 (UMLS CUI [1])
Creatinine
Item
4. impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
boolean
C0201976 (UMLS CUI [1])
Coronary stenosis localisation
Item
5. target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require treatment;
boolean
C0242231 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])

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