ID

20451

Description

Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD); ODM derived from: https://clinicaltrials.gov/show/NCT00431145

Link

https://clinicaltrials.gov/show/NCT00431145

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00431145

English

Eligibility Coronary Artery Disease NCT00431145

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be at least 18 years old, male or female
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have stable coronary artery disease (i.e. no acute event like myocardial infarction or ptca less then 3 months ago)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0027051
UMLS CUI [3]
C2936173
ldl > 100 mg/dl
Description

Serum LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
hdl < 50 mg/dl
Description

Serum HDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428472
triglycerides < 400 mg/dl
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
no nicotine abuse for at least 3 months
Description

Nicotine abuse

Data type

boolean

Alias
UMLS CUI [1]
C2363943
statin-therapy for more than 4 weeks
Description

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0360714
give a written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential, pregnancy or being lactating
Description

Childbearing Potential | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
current participation in another clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
have other severe concurrent illness (e.g., active infection, malignancy)
Description

Illness Severe | Communicable Diseases | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0006826
have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0332218
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0750558
have significant or unexplained liver dysfunction or chronic increased levels of transaminases (alt, ast)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2,1]
C0151905
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0151904
UMLS CUI [3,2]
C0205191
suffer from myopathy, active peptic disease or arterial bleeding
Description

Myopathy | Peptic Ulcer | Arterial hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0026848
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0340654
have a known hypersensitivity against niacin or statins
Description

Nicotinic acid allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0571833
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0360714
are actually treated with any of itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.
Description

Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone

Data type

boolean

Alias
UMLS CUI [1]
C0064113
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0162714
UMLS CUI [4]
C0014806
UMLS CUI [5]
C0055856
UMLS CUI [6]
C0907410
UMLS CUI [7]
C0068485
actual therapy with ezetimibe
Description

ezetimibe

Data type

boolean

Alias
UMLS CUI [1]
C1142985
diabetes mellitus type i
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
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Similar models

Eligibility Coronary Artery Disease NCT00431145

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone
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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