Eligibility Coronary Artery Disease NCT00431145

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StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT00431145

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

be at least 18 years old, male or female

boolean

C0001779 (UMLS CUI [1])

Coronary Artery Disease Stable | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty

Item

have stable coronary artery disease (i.e. no acute event like myocardial infarction or ptca less then 3 months ago)

boolean

C1956346 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C2936173 (UMLS CUI [3])

Serum LDL cholesterol measurement

Item

ldl > 100 mg/dl

boolean

C0428474 (UMLS CUI [1])

Serum HDL cholesterol measurement

Item

hdl < 50 mg/dl

boolean

C0428472 (UMLS CUI [1])

Triglycerides measurement

Item

triglycerides < 400 mg/dl

boolean

C0202236 (UMLS CUI [1])

Nicotine abuse

Item

no nicotine abuse for at least 3 months

boolean

C2363943 (UMLS CUI [1])

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Item

statin-therapy for more than 4 weeks

boolean

C0360714 (UMLS CUI [1])

Informed Consent

Item

give a written informed consent

boolean

C0021430 (UMLS CUI [1])

Protocol Compliance

Item

have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

boolean

C0525058 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Childbearing Potential | Pregnancy | Breast Feeding

Item

women of childbearing potential, pregnancy or being lactating

boolean

C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Study Subject Participation Status

Item

current participation in another clinical trial

boolean

C2348568 (UMLS CUI [1])

Illness Severe | Communicable Diseases | Malignant Neoplasms

Item

have other severe concurrent illness (e.g., active infection, malignancy)

boolean

C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0006826 (UMLS CUI [3])

Substance Use Disorders | Factor Follow-up Difficult | Factor Follow-up Unlikely

Item

have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.

boolean

C0038586 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])

Liver Dysfunction | Alanine aminotransferase increased chronic | Aspartate aminotransferase increased chronic

Item

have significant or unexplained liver dysfunction or chronic increased levels of transaminases (alt, ast)

boolean

C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0151904 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])

Myopathy | Peptic Ulcer | Arterial hemorrhage

Item

suffer from myopathy, active peptic disease or arterial bleeding

boolean

C0026848 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0340654 (UMLS CUI [3])

Nicotinic acid allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors

Item

have a known hypersensitivity against niacin or statins

boolean

C0571833 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])

Item

are actually treated with any of itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.

boolean

C0064113 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0162714 (UMLS CUI [3])
C0014806 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0907410 (UMLS CUI [6])
C0068485 (UMLS CUI [7])

ezetimibe

Item

actual therapy with ezetimibe

boolean

C1142985 (UMLS CUI [1])

Diabetes Mellitus, Insulin-Dependent

Item

diabetes mellitus type i

boolean

C0011854 (UMLS CUI [1])

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Eligibility Coronary Artery Disease NCT00431145