ID

28776

Description

Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00939237

Link

https://clinicaltrials.gov/show/NCT00939237

Keywords

Versions (1)
  1. 2/3/18 2/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00939237

English

Eligibility Coronary Heart Disease NCT00939237

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
brigham and women's hospital cardiology clinic patients with history of coronary heart disease occurring at least 6 months ago:
Description

Coronary heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0010068
history of myocardial infarction (mi) confirmed by medical records and/or
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
history of percutaneous coronary intervention (pci) or coronary artery bypass surgery (cabg)
Description

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
compliance during run-in as demonstrated by taking at least 66% of study medications
Description

Protocol Compliance | Intake Investigational New Drugs Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0439165
ability and willingness to complete questionnaires concerning medical history, concomitant medication use, coronary heart disease risk factors, potential adverse events, and diet
Description

Questionnaires Completion | Medical History | Pharmaceutical Preparations Use of | Coronary heart disease Risk factors | Adverse event potential | Diet

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0262926
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1524063
UMLS CUI [4,1]
C0010068
UMLS CUI [4,2]
C0035648
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C3245505
UMLS CUI [6]
C0012155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of carotid stent, carotid endarterectomy, or carotid artery surgery
Description

Carotid stent | Carotid Endarterectomy | Carotid surgery

Data type

boolean

Alias
UMLS CUI [1]
C0850458
UMLS CUI [2]
C0014099
UMLS CUI [3]
C0741984
history of diagnosed congestive heart failure meeting new york association functional classification iii or iv criteria
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
any initiation or change in statin use or other lipid-lowering treatment within 3 months of randomization
Description

Statin Use of Initiation | Statin Use of Change | Lipid-lowering therapy Initiation | Lipid-lowering therapy Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1704686
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C0585943
UMLS CUI [3,2]
C1704686
UMLS CUI [4,1]
C0585943
UMLS CUI [4,2]
C0392747
lactose intolerance
Description

Lactose Intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0022951
allergies to whey protein
Description

Hypersensitivity Whey Proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0078479
allergies to soy protein
Description

Allergy to soy protein products

Data type

boolean

Alias
UMLS CUI [1]
C2136331
history of active cancer diagnosis (except non-melanoma skin cancer) within last 3 years
Description

Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
life expectancy < 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
women who are pregnant, nursing, or intend pregnancy during the period of treatment
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
plan to relocate out of boston area within the next year
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
carotid artery occlusion or dissection at baseline carotid imt assessment
Description

Carotid artery occlusion | Carotid artery dissection | Carotid Intima-Media Thickness

Data type

boolean

Alias
UMLS CUI [1]
C0265101
UMLS CUI [2]
C0338585
UMLS CUI [3]
C1960466
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Similar models

Eligibility Coronary Heart Disease NCT00939237

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Coronary heart disease
Item
brigham and women's hospital cardiology clinic patients with history of coronary heart disease occurring at least 6 months ago:
boolean
C0010068 (UMLS CUI [1])
Myocardial Infarction
Item
history of myocardial infarction (mi) confirmed by medical records and/or
boolean
C0027051 (UMLS CUI [1])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
history of percutaneous coronary intervention (pci) or coronary artery bypass surgery (cabg)
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Protocol Compliance | Intake Investigational New Drugs Percentage
Item
compliance during run-in as demonstrated by taking at least 66% of study medications
boolean
C0525058 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Questionnaires Completion | Medical History | Pharmaceutical Preparations Use of | Coronary heart disease Risk factors | Adverse event potential | Diet
Item
ability and willingness to complete questionnaires concerning medical history, concomitant medication use, coronary heart disease risk factors, potential adverse events, and diet
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0010068 (UMLS CUI [4,1])
C0035648 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C3245505 (UMLS CUI [5,2])
C0012155 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Carotid stent | Carotid Endarterectomy | Carotid surgery
Item
history of carotid stent, carotid endarterectomy, or carotid artery surgery
boolean
C0850458 (UMLS CUI [1])
C0014099 (UMLS CUI [2])
C0741984 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
history of diagnosed congestive heart failure meeting new york association functional classification iii or iv criteria
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Statin Use of Initiation | Statin Use of Change | Lipid-lowering therapy Initiation | Lipid-lowering therapy Change
Item
any initiation or change in statin use or other lipid-lowering treatment within 3 months of randomization
boolean
C0360714 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0360714 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0585943 (UMLS CUI [3,1])
C1704686 (UMLS CUI [3,2])
C0585943 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
Lactose Intolerance
Item
lactose intolerance
boolean
C0022951 (UMLS CUI [1])
Hypersensitivity Whey Proteins
Item
allergies to whey protein
boolean
C0020517 (UMLS CUI [1,1])
C0078479 (UMLS CUI [1,2])
Allergy to soy protein products
Item
allergies to soy protein
boolean
C2136331 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
history of active cancer diagnosis (except non-melanoma skin cancer) within last 3 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, nursing, or intend pregnancy during the period of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Relocation of home Planned
Item
plan to relocate out of boston area within the next year
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Carotid artery occlusion | Carotid artery dissection | Carotid Intima-Media Thickness
Item
carotid artery occlusion or dissection at baseline carotid imt assessment
boolean
C0265101 (UMLS CUI [1])
C0338585 (UMLS CUI [2])
C1960466 (UMLS CUI [3])
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