ID

11727

Description

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing. https://www.clinicaltrials.gov/ct2/show/NCT00552188

Link

https://www.clinicaltrials.gov/ct2/show/NCT00552188

Keywords

Versions (1)
  1. 7/28/15 7/28/15 -
Uploaded on

July 28, 2015

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Vascular Inflammation Acute Coronary Syndrome NCT00552188

English

Eligibility Critera

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Critera
Inclusion Criteria
Description

Inclusion Criteria

Female patients must be of non-childbearing potential
Description

Female patients must be of non-childbearing potential

Data type

boolean

Alias
UMLS CUI-1
C0549206
Recent acute coronary syndrome
Description

Recent acute coronary syndrome

Data type

boolean

Alias
UMLS CUI-1
C0948089
Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
Description

Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6

Data type

boolean

Alias
UMLS CUI-1
C0751633
Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
Description

Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI-1
C0360714
Exclusion Criteria
Description

Exclusion Criteria

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Description

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI-1
C0035078
Cirrhosis
Description

Cirrhosis

Data type

boolean

Alias
UMLS CUI-1
C0023890
Recent hepatitis
Description

Recent hepatitis

Data type

boolean

Alias
UMLS CUI-1
C0019158
Alanine aminotransferase (ALT) >1.5 x ULN
Description

Alanine aminotransferase (ALT) >1.5 x ULN

Data type

boolean

Alias
UMLS CUI-1
C0201836
Positive screening test for hepatitis B (hepatitis B surface antigen)
Description

Positive screening test for hepatitis B (hepatitis B surface antigen)

Data type

boolean

Alias
UMLS CUI-1
C0019163
Positive screening test for hepatitis C (by ELISA)
Description

Positive screening test for hepatitis C (by ELISA)

Data type

boolean

Alias
UMLS CUI-1
C0019196
Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
Description

Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%

Data type

boolean

Alias
UMLS CUI-1
C0011849
Heart failure defined by New York Heart Association Class III or IV
Description

Heart failure defined by New York Heart Association Class III or IV

Data type

boolean

Alias
UMLS CUI-1
C0018801
Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
Description

Coronary Artery Bypass Surgery (CABG) within 4 months of randomization

Data type

boolean

Alias
UMLS CUI-1
C0010055
Use of zileuton
Description

Use of zileuton

Data type

boolean

Alias
UMLS CUI-1
C0081408
Use of montelukast
Description

Use of montelukast

Data type

boolean

Alias
UMLS CUI-1
C0298130
Use of coumadin
Description

Use of coumadin

Data type

boolean

Alias
UMLS CUI-1
C0699129
steroids
Description

steroids

Data type

boolean

Alias
UMLS CUI-1
C0038317
Acetaminophen use in any form in the 7 days before enrollment at Visit 1
Description

Acetaminophen use in any form in the 7 days before enrollment at Visit 1

Data type

boolean

Alias
UMLS CUI-1
C0000970
Allergy to contrast agents
Description

Allergy to contrast agents

Data type

boolean

Alias
UMLS CUI-1
C0570562
Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
Description

Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months

Data type

boolean

Alias
UMLS CUI-1
C1532338
Current atrial fibrillation
Description

Current atrial fibrillation

Data type

boolean

Alias
UMLS CUI-1
C0004238
Current atrial flutter
Description

Current atrial flutter

Data type

boolean

Alias
UMLS CUI-1
C0004239
Frequent premature ventricular contractions
Description

Frequent premature ventricular contractions

Data type

boolean

Alias
UMLS CUI-1
C0151636
Back to the top of the page

Similar models

Eligibility Critera

1 forms
  1. StudyEvent: ODM
    1. Eligibility Critera
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Pregnancy
Item
Female patients must be of non-childbearing potential
boolean
C0549206 (UMLS CUI-1)
Acute coronary syndrome
Item
Recent acute coronary syndrome
boolean
C0948089 (UMLS CUI-1)
Carotid artery plaque
Item
Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
boolean
C0751633 (UMLS CUI-1)
Statins
Item
Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
boolean
C0360714 (UMLS CUI-1)
Item Group
Exclusion Criteria
Kidney failure
Item
Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
boolean
C0035078 (UMLS CUI-1)
Liver Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI-1)
Hepatitis
Item
Recent hepatitis
boolean
C0019158 (UMLS CUI-1)
ALT
Item
Alanine aminotransferase (ALT) >1.5 x ULN
boolean
C0201836 (UMLS CUI-1)
Hepatitis B
Item
Positive screening test for hepatitis B (hepatitis B surface antigen)
boolean
C0019163 (UMLS CUI-1)
Hepatits C
Item
Positive screening test for hepatitis C (by ELISA)
boolean
C0019196 (UMLS CUI-1)
Diabetes mellitus
Item
Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
boolean
C0011849 (UMLS CUI-1)
Heart failure
Item
Heart failure defined by New York Heart Association Class III or IV
boolean
C0018801 (UMLS CUI-1)
CABG
Item
Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
boolean
C0010055 (UMLS CUI-1)
zileuton
Item
Use of zileuton
boolean
C0081408 (UMLS CUI-1)
montelukast
Item
Use of montelukast
boolean
C0298130 (UMLS CUI-1)
coumadin
Item
Use of coumadin
boolean
C0699129 (UMLS CUI-1)
Steroids
Item
steroids
boolean
C0038317 (UMLS CUI-1)
Acetaminophen
Item
Acetaminophen use in any form in the 7 days before enrollment at Visit 1
boolean
C0000970 (UMLS CUI-1)
Allergy to contrast media
Item
Allergy to contrast agents
boolean
C0570562 (UMLS CUI-1)
PCI
Item
Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
boolean
C1532338 (UMLS CUI-1)
Atrial fibrillation
Item
Current atrial fibrillation
boolean
C0004238 (UMLS CUI-1)
Atrial flutter
Item
Current atrial flutter
boolean
C0004239 (UMLS CUI-1)
Premature ventricular contractions
Item
Frequent premature ventricular contractions
boolean
C0151636 (UMLS CUI-1)
Back to the top of the page 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial