ID

21244

Description

Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00603590

Link

https://clinicaltrials.gov/show/NCT00603590

Keywords

Versions (1)
  1. 4/16/17 4/16/17 -
Uploaded on

April 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00603590

English

Eligibility Cardiovascular Disease NCT00603590

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all men over 50 to 80 and all women 55 to 80 who are resident in kalaleh, golestan, for at least one year.
Description

age, resident

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2347958
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
already taking antihypertensive drugs, aspirin or statins
Description

antihypertensive drugs, aspirin, statins

Data type

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0360714
already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
Description

indication for antihypertensive drug, aspirin or statins

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444656
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C1444656
UMLS CUI [3,1]
C0360714
UMLS CUI [3,2]
C1444656
blood pressure >160/100 mm hg
Description

blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
total cholesterol > 240 mg/dl (or ldl >190 mg/dl)
Description

total cholesterol

Data type

boolean

Alias
UMLS CUI [1]
C1445957
probable diabetes: hba1c >6.0
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
contraindication to a component of the polypill
Description

polypill contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0522473
contraindications to aspirin
Description

aspirin contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0522473
previous history of allergy to aspirin
Description

aspirin allergy

Data type

boolean

Alias
UMLS CUI [1]
C0004058
history of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
Description

peptic ulcer (bleeding)

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0030922
contraindications to statins
Description

statin contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0522473
liver failure contraindications to further blood pressure lowering
Description

liver failure contraindication to blood pressure lowering

Data type

boolean

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0003364
systolic blood pressure ≤90 mm hg or diastolic blood pressure ≤70 mm hg
Description

systolic blood pressure, diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
symptomatic postural hypotension
Description

symptomatic orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0740482
difference between mean seated bp and standing bp greater than 20 mm hg
Description

difference between mean seated blood pressure and standing blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C0428886
UMLS CUI [2,2]
C0231472
contraindications to thiazide
Description

thiazide contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0541746
UMLS CUI [1,2]
C0522473
uric acid >8 for men and uric acid >6 for women / gout (~10%)
Description

uric acid, gout

Data type

boolean

Alias
UMLS CUI [1]
C0041980
UMLS CUI [2]
C0018099
creatinine >1.2 mg/dl
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
other predominant medical problem that may limit compliance with study treatment including:
Description

comorbidities limiting compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
history of alcohol abuse: more than 60cc for women and more than 80cc for men
Description

alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
history of drug abuse: iv drug abuser or eating or smoking more than 4 times a week
Description

drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
Description

psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0004936
limiting physical disability sufficient to prevent subject from walking
Description

walking ability

Data type

boolean

Alias
UMLS CUI [1]
C0559964
other life-threatening condition such as cancer
Description

life-threatening condition

Data type

boolean

Alias
UMLS CUI [1,1]
C2826244
UMLS CUI [1,2]
C0012634
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Similar models

Eligibility Cardiovascular Disease NCT00603590

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age, resident
Item
all men over 50 to 80 and all women 55 to 80 who are resident in kalaleh, golestan, for at least one year.
boolean
C0001779 (UMLS CUI [1])
C2347958 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cardiovascular disease
Item
existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
boolean
C0007222 (UMLS CUI [1])
antihypertensive drugs, aspirin, statins
Item
already taking antihypertensive drugs, aspirin or statins
boolean
C0003364 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0360714 (UMLS CUI [3])
indication for antihypertensive drug, aspirin or statins
Item
already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
boolean
C0003364 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C1444656 (UMLS CUI [2,2])
C0360714 (UMLS CUI [3,1])
C1444656 (UMLS CUI [3,2])
blood pressure
Item
blood pressure >160/100 mm hg
boolean
C0005823 (UMLS CUI [1])
total cholesterol
Item
total cholesterol > 240 mg/dl (or ldl >190 mg/dl)
boolean
C1445957 (UMLS CUI [1])
hba1c
Item
probable diabetes: hba1c >6.0
boolean
C0019018 (UMLS CUI [1])
polypill contraindication
Item
contraindication to a component of the polypill
boolean
C0013227 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
aspirin contraindication
Item
contraindications to aspirin
boolean
C0004057 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
aspirin allergy
Item
previous history of allergy to aspirin
boolean
C0004058 (UMLS CUI [1])
peptic ulcer (bleeding)
Item
history of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
boolean
C0030920 (UMLS CUI [1])
C0030922 (UMLS CUI [2])
statin contraindication
Item
contraindications to statins
boolean
C0360714 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
liver failure contraindication to blood pressure lowering
Item
liver failure contraindications to further blood pressure lowering
boolean
C0085605 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
systolic blood pressure, diastolic blood pressure
Item
systolic blood pressure ≤90 mm hg or diastolic blood pressure ≤70 mm hg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
symptomatic orthostatic hypotension
Item
symptomatic postural hypotension
boolean
C0740482 (UMLS CUI [1])
difference between mean seated blood pressure and standing blood pressure
Item
difference between mean seated bp and standing bp greater than 20 mm hg
boolean
C0428886 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0428886 (UMLS CUI [2,1])
C0231472 (UMLS CUI [2,2])
thiazide contraindication
Item
contraindications to thiazide
boolean
C0541746 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
uric acid, gout
Item
uric acid >8 for men and uric acid >6 for women / gout (~10%)
boolean
C0041980 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
creatinine
Item
creatinine >1.2 mg/dl
boolean
C0201976 (UMLS CUI [1])
comorbidities limiting compliance
Item
other predominant medical problem that may limit compliance with study treatment including:
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
alcohol abuse
Item
history of alcohol abuse: more than 60cc for women and more than 80cc for men
boolean
C0085762 (UMLS CUI [1])
drug abuse
Item
history of drug abuse: iv drug abuser or eating or smoking more than 4 times a week
boolean
C0013146 (UMLS CUI [1])
psychiatric illness
Item
limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
boolean
C0004936 (UMLS CUI [1])
walking ability
Item
limiting physical disability sufficient to prevent subject from walking
boolean
C0559964 (UMLS CUI [1])
life-threatening condition
Item
other life-threatening condition such as cancer
boolean
C2826244 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
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