ID

13961

Beskrivning

HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study); ODM derived from: https://clinicaltrials.gov/show/NCT00106886

Länk

https://clinicaltrials.gov/show/NCT00106886

Nyckelord

Versioner (1)
  1. 20-03-16 20-03-16 -
Uppladdad den

20 maart 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00106886

Engelsk

Eligibility Cardiovascular Disease NCT00106886

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women and men 55 years of age or over with established cvd and at high risk for future fatal and nonfatal cv events, defined as:
Beskrivning

Age, Cardiovasclar Disease and cardiovascular risk factors

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0850624
1. documented coronary artery disease (cad);
Beskrivning

Coronary artery disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
2. documented peripheral vascular disease (pvd);
Beskrivning

Peripheral vascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0085096
3. documented cerebrovascular disease;
Beskrivning

Cerebrovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007820
4. diabetes with one of the following; additional cardiovascular risk factors:
Beskrivning

Diabetes with cardiovascular risk factors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0850624
i) hypertension (bp >160 mmhg systolic or >90 mmhg diastolic or on treatment); ii) total cholesterol >5.2 mmol/l (>200 mg/dl); iii) hdl cholesterol <0.9 mmol/l (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease
Beskrivning

Cardiovascular Risk factors

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0585941
UMLS CUI [4]
C1445957
UMLS CUI [5]
C0428472
UMLS CUI [6]
C1519386
UMLS CUI [7]
C1881056
provision of informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of any vitamin supplements containing folic acid >200 micrograms/day. the patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. if they agree, they can be randomized to the study following a one month wash-out period.
Beskrivning

Folic acid supplementation

Datatyp

boolean

Alias
UMLS CUI [1]
C0556110
known previous adverse reactions to folic acid and/or vitamin b6 and/or b12.
Beskrivning

Adverse reactions

Datatyp

boolean

Alias
UMLS CUI [1]
C0413670
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0087162
UMLS CUI [3]
C0570376
planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months.
Beskrivning

Revascularization

Datatyp

boolean

Alias
UMLS CUI [1]
C0581603
hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
Beskrivning

Valvular outflow tract obstruction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0028778
constrictive pericarditis.
Beskrivning

Constrictive pericarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0031048
complex congenital heart disease.
Beskrivning

Congenital heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria.
Beskrivning

Syncopal episodes due to arrhythmias

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0039070
uncontrolled hypertension.
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
cor pulmonale.
Beskrivning

Cor pulmonale

Datatyp

boolean

Alias
UMLS CUI [1]
C0034072
heart transplant recipient.
Beskrivning

Heart transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0018823
other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient's ability to complete the study, such as: *history of alcohol or drug abuse, *psychiatric disorders, *senility, *severe physical disability,
Beskrivning

Comorbidity affecting Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
*illnesses including terminal stage of cancer and other major systemic illnesses expected to limit the patient's ability to comply with the study protocol and to complete the study.
Beskrivning

Comorbidity affecting study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
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Similar models

Eligibility Cardiovascular Disease NCT00106886

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age, Cardiovasclar Disease and cardiovascular risk factors
Item
women and men 55 years of age or over with established cvd and at high risk for future fatal and nonfatal cv events, defined as:
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0850624 (UMLS CUI [3])
Coronary artery disease
Item
1. documented coronary artery disease (cad);
boolean
C1956346 (UMLS CUI [1])
Peripheral vascular disease
Item
2. documented peripheral vascular disease (pvd);
boolean
C0085096 (UMLS CUI [1])
Cerebrovascular disease
Item
3. documented cerebrovascular disease;
boolean
C0007820 (UMLS CUI [1])
Diabetes with cardiovascular risk factors
Item
4. diabetes with one of the following; additional cardiovascular risk factors:
boolean
C0011849 (UMLS CUI [1,1])
C0850624 (UMLS CUI [1,2])
Cardiovascular Risk factors
Item
i) hypertension (bp >160 mmhg systolic or >90 mmhg diastolic or on treatment); ii) total cholesterol >5.2 mmol/l (>200 mg/dl); iii) hdl cholesterol <0.9 mmol/l (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
C1445957 (UMLS CUI [4])
C0428472 (UMLS CUI [5])
C1519386 (UMLS CUI [6])
C1881056 (UMLS CUI [7])
informed consent
Item
provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Folic acid supplementation
Item
current use of any vitamin supplements containing folic acid >200 micrograms/day. the patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. if they agree, they can be randomized to the study following a one month wash-out period.
boolean
C0556110 (UMLS CUI [1])
Adverse reactions
Item
known previous adverse reactions to folic acid and/or vitamin b6 and/or b12.
boolean
C0413670 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0087162 (UMLS CUI [2,2])
C0570376 (UMLS CUI [3])
Revascularization
Item
planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months.
boolean
C0581603 (UMLS CUI [1])
Valvular outflow tract obstruction
Item
hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
boolean
C0018824 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
Constrictive pericarditis
Item
constrictive pericarditis.
boolean
C0031048 (UMLS CUI [1])
Congenital heart disease
Item
complex congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
Syncopal episodes due to arrhythmias
Item
syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria.
boolean
C0003811 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Cor pulmonale
Item
cor pulmonale.
boolean
C0034072 (UMLS CUI [1])
Heart transplantation
Item
heart transplant recipient.
boolean
C0018823 (UMLS CUI [1])
Comorbidity affecting Compliance
Item
other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient's ability to complete the study, such as: *history of alcohol or drug abuse, *psychiatric disorders, *senility, *severe physical disability,
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Comorbidity affecting study protocol
Item
*illnesses including terminal stage of cancer and other major systemic illnesses expected to limit the patient's ability to comply with the study protocol and to complete the study.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
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