ID

23713

Description

Heart Outcomes Prevention Evaluation-3; ODM derived from: https://clinicaltrials.gov/show/NCT00468923

Link

https://clinicaltrials.gov/show/NCT00468923

Keywords

Versions (1)
  1. 7/11/17 7/11/17 -
Uploaded on

July 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00468923

English

Eligibility Cardiovascular Disease NCT00468923

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged > 60 years and men > 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least one additional cv risk factor including:
Description

Cardiovascular risk factor Additional Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0850624
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1265611
waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
Description

Waist-Hip Ratio | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0205682
UMLS CUI [2]
C0079399
history of current or recent smoking (regular tobacco use within 5 years)
Description

Tobacco use Regular Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0449238
low hdl cholesterol
Description

Decreased HDL cholesterol

Data type

boolean

Alias
UMLS CUI [1]
C0151691
dysglycemia
Description

Dysglycemia

Data type

boolean

Alias
UMLS CUI [1]
C1960636
renal dysfunction
Description

Renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3279454
family history of premature chd in first degree relatives
Description

FH: premature coronary heart disease First Degree Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C1277208
UMLS CUI [1,2]
C1517194
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented clinically manifest atherothrombotic cvd
Description

Atherothrombosis Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1963943
UMLS CUI [1,2]
C0007222
clear indication or contraindication for statin and/or arb or ace inhibitor and/or thiazide diuretic therapy
Description

Indication Statin | Indication Angiotensin II receptor antagonist | Indication Angiotensin-Converting Enzyme Inhibitors | Indication Thiazide Diuretics | Medical contraindication Statin | Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Thiazide Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0360714
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0521942
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0003015
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0012802
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0360714
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0521942
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0003015
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0012802
symptomatic hypotension
Description

Hypotension symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0863113
chronic liver disease
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
inflammatory muscle disease
Description

Myositis

Data type

boolean

Alias
UMLS CUI [1]
C0027121
renal impairment
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
Description

Cyclosporine | Condition Resulting in Organ Transplantation | Condition Requirement Cyclosporine

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0029216
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0010592
concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ace inhibitor, or a thiazide diuretic
Description

Statin | Fibrates | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Thiazide Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C1449704
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0003015
UMLS CUI [5]
C0012802
other serious medical illness likely to interfere with study participation or with the ability to complete the trial
Description

Illness Serious Interferes with Study Subject Participation Status | Illness Serious Interferes with Clinical Trial Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0008976
UMLS CUI [2,5]
C0205197
significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
Description

Mental disorders | Senility | Dementia | Substance Use Disorders | Informed Consent Ability Limited | Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0231337
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0038586
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C0085732
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0525058
UMLS CUI [6,2]
C0439801
concurrent use of an experimental pharmacological agent
Description

Pharmacologic Substance Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C1254351
UMLS CUI [1,2]
C1517586
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Similar models

Eligibility Cardiovascular Disease NCT00468923

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
women aged > 60 years and men > 55 years
boolean
C0001779 (UMLS CUI [1])
Cardiovascular risk factor Additional Quantity
Item
at least one additional cv risk factor including:
boolean
C0850624 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Waist-Hip Ratio | Gender
Item
waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
boolean
C0205682 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Tobacco use Regular Duration
Item
history of current or recent smoking (regular tobacco use within 5 years)
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Decreased HDL cholesterol
Item
low hdl cholesterol
boolean
C0151691 (UMLS CUI [1])
Dysglycemia
Item
dysglycemia
boolean
C1960636 (UMLS CUI [1])
Renal dysfunction
Item
renal dysfunction
boolean
C3279454 (UMLS CUI [1])
FH: premature coronary heart disease First Degree Relative
Item
family history of premature chd in first degree relatives
boolean
C1277208 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Atherothrombosis Cardiovascular Disease
Item
documented clinically manifest atherothrombotic cvd
boolean
C1963943 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
Indication Statin | Indication Angiotensin II receptor antagonist | Indication Angiotensin-Converting Enzyme Inhibitors | Indication Thiazide Diuretics | Medical contraindication Statin | Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Thiazide Diuretics
Item
clear indication or contraindication for statin and/or arb or ace inhibitor and/or thiazide diuretic therapy
boolean
C3146298 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0003015 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C0012802 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0360714 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0521942 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0003015 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0012802 (UMLS CUI [8,2])
Hypotension symptomatic
Item
symptomatic hypotension
boolean
C0863113 (UMLS CUI [1])
Chronic liver disease
Item
chronic liver disease
boolean
C0341439 (UMLS CUI [1])
Myositis
Item
inflammatory muscle disease
boolean
C0027121 (UMLS CUI [1])
Renal Insufficiency
Item
renal impairment
boolean
C1565489 (UMLS CUI [1])
Cyclosporine | Condition Resulting in Organ Transplantation | Condition Requirement Cyclosporine
Item
concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
boolean
C0010592 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0029216 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0010592 (UMLS CUI [3,3])
Statin | Fibrates | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Thiazide Diuretics
Item
concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ace inhibitor, or a thiazide diuretic
boolean
C0360714 (UMLS CUI [1])
C1449704 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0003015 (UMLS CUI [4])
C0012802 (UMLS CUI [5])
Illness Serious Interferes with Study Subject Participation Status | Illness Serious Interferes with Clinical Trial Completion
Item
other serious medical illness likely to interfere with study participation or with the ability to complete the trial
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0205197 (UMLS CUI [2,5])
Mental disorders | Senility | Dementia | Substance Use Disorders | Informed Consent Ability Limited | Protocol Compliance Limited
Item
significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
boolean
C0004936 (UMLS CUI [1])
C0231337 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
C0021430 (UMLS CUI [5,1])
C0085732 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0525058 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
Pharmacologic Substance Investigational
Item
concurrent use of an experimental pharmacological agent
boolean
C1254351 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
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