ID

38454

Description

Polypill For Prevention of Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00567307

Link

https://clinicaltrials.gov/show/NCT00567307

Keywords

Versions (1)
  1. 10/18/19 10/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00567307

English

Eligibility Cardiovascular Disease NCT00567307

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
estimated 10-year total cvd risk score > 20%. the total cvd risk assessment will be based on the recently developed who cvd risk prediction charts
Description

Cardiovascular Disease Risk Score | Cardiovascular Disease Risk Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0449820
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0086930
no contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
Description

Medical contraindication Absent Aspirin | Medical contraindication Absent Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Absent Diuretics Low dose | Medical contraindication Absent Statins

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0003015
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0012798
UMLS CUI [3,4]
C0445550
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0360714
informed consent given
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy left ventricular hypertrophy (on ecg) or hypertensive retinopathy (grade iii or iv)
Description

Angina Pectoris | Coronary heart disease | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Peripheral Vascular Disease | Coronary revascularisation | Carotid Endarterectomy | Electrocardiogram: left ventricle hypertrophy | Hypertensive Retinopathy Grade

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0085096
UMLS CUI [7]
C0877341
UMLS CUI [8]
C0014099
UMLS CUI [9]
C0232306
UMLS CUI [10,1]
C0152132
UMLS CUI [10,2]
C0441800
patients with secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Neuropathy | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0442874
UMLS CUI [4]
C0022658
known renal failure or impairment
Description

Kidney Failure | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C1565489
atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
alt > 1.5 times the upper limit of normal
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
history of liver cirrhosis or hepatitis
Description

Liver Cirrhosis | Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0019158
history of recent gastrointestinal bleeding (within the last year)
Description

Gastrointestinal Hemorrhage Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0332185
women in child bearing period
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
history of life-limiting diseases or events
Description

Disease Limiting Life | Event Limiting Life

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0376558
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0376558
unwillingness to sign informed consent.
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Cardiovascular Disease NCT00567307

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cardiovascular Disease Risk Score | Cardiovascular Disease Risk Assessment
Item
estimated 10-year total cvd risk score > 20%. the total cvd risk assessment will be based on the recently developed who cvd risk prediction charts
boolean
C0007222 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2,1])
C0086930 (UMLS CUI [2,2])
Medical contraindication Absent Aspirin | Medical contraindication Absent Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Absent Diuretics Low dose | Medical contraindication Absent Statins
Item
no contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003015 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0012798 (UMLS CUI [3,3])
C0445550 (UMLS CUI [3,4])
C1301624 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0360714 (UMLS CUI [4,3])
Informed Consent
Item
informed consent given
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Angina Pectoris | Coronary heart disease | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Peripheral Vascular Disease | Coronary revascularisation | Carotid Endarterectomy | Electrocardiogram: left ventricle hypertrophy | Hypertensive Retinopathy Grade
Item
patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy left ventricular hypertrophy (on ecg) or hypertensive retinopathy (grade iii or iv)
boolean
C0002962 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
C0877341 (UMLS CUI [7])
C0014099 (UMLS CUI [8])
C0232306 (UMLS CUI [9])
C0152132 (UMLS CUI [10,1])
C0441800 (UMLS CUI [10,2])
Secondary hypertension
Item
patients with secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Neuropathy | Kidney Disease
Item
patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0442874 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Kidney Failure | Renal Insufficiency
Item
known renal failure or impairment
boolean
C0035078 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Atrial Fibrillation
Item
atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt > 1.5 times the upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Liver Cirrhosis | Hepatitis
Item
history of liver cirrhosis or hepatitis
boolean
C0023890 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
Gastrointestinal Hemorrhage Recent
Item
history of recent gastrointestinal bleeding (within the last year)
boolean
C0017181 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Childbearing Potential
Item
women in child bearing period
boolean
C3831118 (UMLS CUI [1])
Disease Limiting Life | Event Limiting Life
Item
history of life-limiting diseases or events
boolean
C0012634 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0376558 (UMLS CUI [1,3])
C0441471 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0376558 (UMLS CUI [2,3])
Informed Consent Unwilling
Item
unwillingness to sign informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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