ID

20451

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00431145

Stichworte

Versionen (1)
  1. 22.02.17 22.02.17 -
Hochgeladen am

22. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00431145

Englisch

Eligibility Coronary Artery Disease NCT00431145

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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)
Beschreibung

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

Datentyp

boolean

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

Serum LDL cholesterol measurement

Datentyp

boolean

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

Serum HDL cholesterol measurement

Datentyp

boolean

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

Triglycerides measurement

Datentyp

boolean

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

Nicotine abuse

Datentyp

boolean

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

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Datentyp

boolean

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

Informed Consent

Datentyp

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.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Childbearing Potential | Pregnancy | Breast Feeding

Datentyp

boolean

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

Study Subject Participation Status

Datentyp

boolean

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

Illness Severe | Communicable Diseases | Malignant Neoplasms

Datentyp

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.
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Myopathy | Peptic Ulcer | Arterial hemorrhage

Datentyp

boolean

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

Nicotinic acid allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

ezetimibe

Datentyp

boolean

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

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00431145

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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