Informações:
Falhas:
ID
13653
Descrição
Single Pill to Avert Cardiovascular Events; ODM derived from: https://clinicaltrials.gov/show/NCT01313702
Link
https://clinicaltrials.gov/show/NCT01313702
Palavras-chave
Versões (1)
- 23/02/2016 23/02/2016 -
Transferido a
23 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01313702
Eligibility Cardiovascular Disease NCT01313702
- StudyEvent: Eligibility
Similar models
Eligibility Cardiovascular Disease NCT01313702
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
contraindication investigational drug
Item
contraindication for any of the polipill
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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])
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])
C0011581 (UMLS CUI [2])
pregnant; lactation
Item
pregnant or lactation women
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
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])
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])