Eligibility Coronary Artery Disease NCT00525954

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StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT00525954

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

ID.1

Item

subjects are eligible for inclusion if they meet the following inclusion criteria:

boolean

C1512693 (UMLS CUI [1])

ID.2

Item

1. men and women ≥18 years of age

boolean

C0001779 (UMLS CUI [1])

ID.3

Item

2. written informed consent from the subject

boolean

C0021430 (UMLS CUI [1])

ID.4

Item

3. stable cad

boolean

C0010068 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])

ID.5

Item

4. stable medical condition, will be compliant and able to comply with the requirements of the protocol

boolean

C0205360 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

ID.6

Item

subjects must not meet any of the following exclusion criteria:

boolean

C0680251 (UMLS CUI [1])

ID.7

Item

1. planned coronary artery bypass surgery (cabg)

boolean

C0010055 (UMLS CUI [1])

ID.8

Item

2. acute or chronic heart failure as defined by the new york heart association (nyha) classification as functional class iii or class iv

boolean

C0018802 (UMLS CUI [1,1])
C0264714 (UMLS CUI [1,2])

ID.9

Item

3. hospitalization for acute coronary syndrome (acs) if troponin >0.1 ng/ml in the preceding 6 weeks

boolean

C0948089 (UMLS CUI [1,1])
C1141948 (UMLS CUI [1,2])

ID.10

Item

4. hospitalization for st-segment elevation acute myocardial infarction (stemi) in the preceding 12 weeks

boolean

C1536220 (UMLS CUI [1])

ID.11

Item

5. subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery

boolean

C1290886 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])

ID.12

Item

6. 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

C1833181 (UMLS CUI [1])

ID.13

Item

7. subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to screening or prior experience with a-002.

boolean

C0681814 (UMLS CUI [1])

ID.14

Item

8. subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy

boolean

C0006826 (UMLS CUI [1])

ID.15

Item

9. subjects who have received immunosuppressant therapy within 30 days prior to entry

boolean

C1096650 (UMLS CUI [1])

ID.16

Item

10. subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry

boolean

C0281481 (UMLS CUI [1])

ID.17

Item

11. the presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, alt or ast >3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x upper limit of normal)

boolean

C3829821 (UMLS CUI [1])

ID.18

Item

12. active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities

boolean

C0016977 (UMLS CUI [1,1])
C0008325 (UMLS CUI [1,2])

ID.19

Item

13. the presence of moderate or severe renal impairment (crcl <60 ml/min or creatinine >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis

boolean

C3829820 (UMLS CUI [1])

ID.20

Item

14. uncontrolled diabetes mellitus (known hba1c >11% within the last 1 month prior to screening)

boolean

C2733146 (UMLS CUI [1])

ID.21

Item

15. females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at visit 1 (if the subject is a female of child-bearing potential). women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. a reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (iud), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).

boolean

C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])

ID.22

Item

16. subjects who have a history of alcohol or drug abuse within 1 year of study entry

boolean

C0085762 (UMLS CUI [1,1])

ID.23

Item

17. subject living too far from participating center or unable to return for follow-up visits

boolean

C3258451 (UMLS CUI [1])

ID.24

Item

18. subjects who in the opinion of the investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions

boolean

C0419566 (UMLS CUI [1,1])
C0815144 (UMLS CUI [1,2])

ID.25

Item

19. known human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection

boolean

C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])

ID.26

Item

20. treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry

boolean

C4053960 (UMLS CUI [1])

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Eligibility Coronary Artery Disease NCT00525954