ID

13653

Beskrivning

Single Pill to Avert Cardiovascular Events; ODM derived from: https://clinicaltrials.gov/show/NCT01313702

Länk

https://clinicaltrials.gov/show/NCT01313702

Nyckelord

Versioner (1)
  1. 2016-02-23 2016-02-23 -
Uppladdad den

23 februari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01313702

Engelsk

Eligibility Cardiovascular Disease NCT01313702

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults age ≥ 18 years old;
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient that could written informed consent;
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
Beskrivning

cardiovascular disease Atherothrombosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1963943
patients with previous coronary artery disease (miocardial infarction, estable or instable angina pectoris or coronary revascularization procedures);
Beskrivning

coronary artery disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
patients with previous myocardial infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,pathological electrocardiogram and elevation of cardiac enzymes- ck-mb and/or troponin);
Beskrivning

myocardial infarction; ck-mb; troponin

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010290
UMLS CUI [3]
C0041199
patients with previous brain ischemia (stroke or transient ischemic attack)
Beskrivning

brain ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0007786
patients with confirmed previous peripheral arterial disease (coronary artery bypass procedures or angioplasty or amputation due peripheral arterial disease)
Beskrivning

peripheral arterial disease; coronary artery bypass

Datatyp

boolean

Alias
UMLS CUI [1]
C1881056
UMLS CUI [2]
C0010055
patients with no established cardiovascular disease but at high cardiovascular risk, defined as 15% or more in 5 years (using the anderson framingham scale, 1991)
Beskrivning

cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication for any of the polipill
Beskrivning

contraindication investigational drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
if the physician opinion is that therapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension [degree 3], malignant hypertension or renal insufficiency
Beskrivning

Compliance behavior Limited Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
acute clinical conditions/ surgeries
Beskrivning

surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
psychiatry clinical conditions(for example, schizophrenia, serious depression)
Beskrivning

schizophrenia; depression

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0011581
pregnant or lactation women
Beskrivning

pregnant; lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)
Beskrivning

Contraception status; condom; intrauterine device

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0677582
UMLS CUI [3]
C0021900
liver diseases (ast/alt/fa upon 3 x normal superior limits / bilirrubin upon 1,5 x normal superior limits / diagnosed liver cirrhosis
Beskrivning

liver cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
renal dysfunction (any laboratorial exams upon 3 x normal superior limits)
Beskrivning

renal dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
previous participation on other clinical trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
the participant is unable or refuse to give informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Tillbaka till toppen

Similar models

Eligibility Cardiovascular Disease NCT01313702

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
adults age ≥ 18 years old;
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patient that could written informed consent;
boolean
C0021430 (UMLS CUI [1])
cardiovascular disease Atherothrombosis
Item
patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
boolean
C0007222 (UMLS CUI [1,1])
C1963943 (UMLS CUI [1,2])
coronary artery disease
Item
patients with previous coronary artery disease (miocardial infarction, estable or instable angina pectoris or coronary revascularization procedures);
boolean
C1956346 (UMLS CUI [1])
myocardial infarction; ck-mb; troponin
Item
patients with previous myocardial infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,pathological electrocardiogram and elevation of cardiac enzymes- ck-mb and/or troponin);
boolean
C0027051 (UMLS CUI [1])
C0010290 (UMLS CUI [2])
C0041199 (UMLS CUI [3])
brain ischemia
Item
patients with previous brain ischemia (stroke or transient ischemic attack)
boolean
C0007786 (UMLS CUI [1])
peripheral arterial disease; coronary artery bypass
Item
patients with confirmed previous peripheral arterial disease (coronary artery bypass procedures or angioplasty or amputation due peripheral arterial disease)
boolean
C1881056 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
cardiovascular disease
Item
patients with no established cardiovascular disease but at high cardiovascular risk, defined as 15% or more in 5 years (using the anderson framingham scale, 1991)
boolean
C0007222 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication investigational drug
Item
contraindication for any of the polipill
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Compliance behavior Limited Comorbidity
Item
if the physician opinion is that therapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension [degree 3], malignant hypertension or renal insufficiency
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
surgery
Item
acute clinical conditions/ surgeries
boolean
C0543467 (UMLS CUI [1])
schizophrenia; depression
Item
psychiatry clinical conditions(for example, schizophrenia, serious depression)
boolean
C0036341 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
pregnant; lactation
Item
pregnant or lactation women
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
Contraception status; condom; intrauterine device
Item
women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)
boolean
C0420837 (UMLS CUI [1])
C0677582 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
liver cirrhosis
Item
liver diseases (ast/alt/fa upon 3 x normal superior limits / bilirrubin upon 1,5 x normal superior limits / diagnosed liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
renal dysfunction
Item
renal dysfunction (any laboratorial exams upon 3 x normal superior limits)
boolean
C3279454 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation on other clinical trial
boolean
C2348568 (UMLS CUI [1])
informed consent
Item
the participant is unable or refuse to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Tillbaka till toppen 

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