Informações:
Falhas:
ID
11727
Descrição
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
Palavras-chave
Versões (1)
- 28/07/2015 28/07/2015 -
Transferido a
28 de julho de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Vascular Inflammation Acute Coronary Syndrome NCT00552188
Similar models
Eligibility Critera
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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)
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)