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ID
28428
Descripción
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00455546
Link
https://clinicaltrials.gov/show/NCT00455546
Palabras clave
Versiones (1)
- 12/1/18 12/1/18 -
Titular de derechos de autor
See clinicaltrials.gov
Subido en
12 de enero de 2018
DOI
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Licencia
Creative Commons BY 4.0
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Eligibility Coronary Artery Disease (CAD) NCT00455546
Eligibility Coronary Artery Disease (CAD) NCT00455546
- StudyEvent: Eligibility
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Eligibility Coronary Artery Disease (CAD) NCT00455546
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Criteria Fulfill
Item
subjects are eligible for inclusion if they meet the following inclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
Age
Item
men and women > 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent from the subject
boolean
C0021430 (UMLS CUI [1])
Coronary Artery Disease Stable
Item
stable cad
boolean
C1956346 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
Medical condition Stable | Protocol Compliance
Item
stable medical condition, will be compliant and able to comply with the requirements of the protocol
boolean
C3843040 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0205360 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Criteria Mismatch
Item
subjects must not meet any of the following exclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
C1881865 (UMLS CUI [1,2])
CABG Planned
Item
planned cabg
boolean
C0010055 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
Hospitalization Acute Coronary Syndrome | Troponin measurement
Item
hospitalization for acute coronary syndrome if troponin level is >0.1 ng/ml in the preceding 6 weeks
boolean
C0019993 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
C0523952 (UMLS CUI [2])
C0948089 (UMLS CUI [1,2])
C0523952 (UMLS CUI [2])
Hospitalization STEMI
Item
hospitalization for st-segment acute myocardial infarction (stemi) in the preceding 12 weeks
boolean
C0019993 (UMLS CUI [1,1])
C1536220 (UMLS CUI [1,2])
C1536220 (UMLS CUI [1,2])
Chronic inflammatory disorder | Rheumatoid Arthritis | Inflammatory Bowel Diseases | Sepsis | Focal Infection Requirement Intervention Clinical | Major surgery
Item
subjects with chronic inflammatory disease (e.g., ra), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
boolean
C1290886 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C0243026 (UMLS CUI [4])
C0016397 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
C0205210 (UMLS CUI [5,4])
C0679637 (UMLS CUI [6])
C0003873 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C0243026 (UMLS CUI [4])
C0016397 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
C0205210 (UMLS CUI [5,4])
C0679637 (UMLS CUI [6])
hsCRP Repeated | Relationship Condition inflammatory systemic | Relationship Rheumatoid Arthritis | Exception Cardiovascular Diseases
Item
hs-crp >15 mg/l repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)
boolean
C0973334 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0333348 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
C0439849 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007222 (UMLS CUI [4,2])
C0205341 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0333348 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
C0439849 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007222 (UMLS CUI [4,2])
Heart failure New York Heart Association Classification | Chronic heart failure New York Heart Association Classification
Item
acute or chronic heart failure as defined by the nyha classification as functional class iii or class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1275491 (UMLS CUI [1,2])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])