Información:
Error:
ID
15023
Descripción
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
Palabras clave
Versiones (1)
- 11/5/16 11/5/16 -
Subido en
11 de mayo de 2016
DOI
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Licencia
Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00232765
Eligibility Coronary Artery Disease NCT00232765
- StudyEvent: Eligibility
Similar models
Eligibility Coronary Artery Disease NCT00232765
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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])
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])
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])
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])
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])
C0449286 (UMLS CUI [1,2])
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])
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])
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])
C0475264 (UMLS CUI [1,2])