ID

28428

Description

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

Keywords

Versions (1)
  1. 1/12/18 1/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease (CAD) NCT00455546

English

Eligibility Coronary Artery Disease (CAD) NCT00455546

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects are eligible for inclusion if they meet the following inclusion criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
men and women > 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent from the subject
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
stable cad
Description

Coronary Artery Disease Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205360
stable medical condition, will be compliant and able to comply with the requirements of the protocol
Description

Medical condition Stable | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must not meet any of the following exclusion criteria:
Description

Criteria Mismatch

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1881865
planned cabg
Description

CABG Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C1301732
hospitalization for acute coronary syndrome if troponin level is >0.1 ng/ml in the preceding 6 weeks
Description

Hospitalization Acute Coronary Syndrome | Troponin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0948089
UMLS CUI [2]
C0523952
hospitalization for st-segment acute myocardial infarction (stemi) in the preceding 12 weeks
Description

Hospitalization STEMI

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1536220
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
Description

Chronic inflammatory disorder | Rheumatoid Arthritis | Inflammatory Bowel Diseases | Sepsis | Focal Infection Requirement Intervention Clinical | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0021390
UMLS CUI [4]
C0243026
UMLS CUI [5,1]
C0016397
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0184661
UMLS CUI [5,4]
C0205210
UMLS CUI [6]
C0679637
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)
Description

hsCRP Repeated | Relationship Condition inflammatory systemic | Relationship Rheumatoid Arthritis | Exception Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0973334
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0333348
UMLS CUI [2,4]
C0205373
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0003873
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007222
acute or chronic heart failure as defined by the nyha classification as functional class iii or class iv
Description

Heart failure New York Heart Association Classification | Chronic heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
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Similar models

Eligibility Coronary Artery Disease (CAD) NCT00455546

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
Criteria Mismatch
Item
subjects must not meet any of the following exclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
CABG Planned
Item
planned cabg
boolean
C0010055 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
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