Eligibility Ischemic Heart Disease NCT02057900

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StudyEvent: Eligibility
1. Eligibility Ischemic Heart Disease NCT02057900

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

age ≥ 18 and less than 81 years

boolean

C0001779 (UMLS CUI [1])

Left ventricular systolic dysfunction Severe | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Scintigraphy

Item

severe left ventricular systolic dysfunction with left ventricular ejection fraction (lvef) ≤ 35% as assessed by echocardiography or scintigraphy

boolean

C1277187 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0034606 (UMLS CUI [3,2])

Myocardial Infarction | Akinesia Residual Echocardiography | Involvement Segment Quantity

Item

history of myocardial infarction (older than 6 months) with a residual akinesia involving more than 2 (out of 16) contiguous segments, as assessed by basal echocardiography

boolean

C0027051 (UMLS CUI [1])
C0085623 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C0013516 (UMLS CUI [2,3])
C1314939 (UMLS CUI [3,1])
C0441635 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])

Item

new york heart association (nyha) class iii or iv despite optimal standard of care including diuretics and angiotensin receptor blockers and, if possible, beta blockers and aldosterone blockers

boolean

C1275491 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
C2215699 (UMLS CUI [6])

Implantation of internal cardiac defibrillator Associated with Cardiac Resynchronization Therapy

Item

previous implantation of an automatic internal defibrillator associated, whenever indicated, to ventricular resynchronization

boolean

C1273352 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1167956 (UMLS CUI [1,3])

Indication Cardiac Surgery procedure | Coronary Artery Bypass Surgery | Mitral valvuloplasty Mitral Valve Insufficiency Ischemic | Replacement of mitral valve Mitral Valve Insufficiency Ischemic | Ineligibility Heart Transplantation | Affiliation Social Security

Item

indication for a conventional cardiac surgical procedure : coronary artery bypass grafting involving, or not, the infarct area planned to be covered by the cell-loaded patch or mitral valve repair or replacement for ischemic mitral valve regurgitation; non eligibility to heart transplantation; affiliation to a social security regimen

boolean

C3146298 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
C0396849 (UMLS CUI [3,1])
C0026266 (UMLS CUI [3,2])
C0475224 (UMLS CUI [3,3])
C0026268 (UMLS CUI [4,1])
C0026266 (UMLS CUI [4,2])
C0475224 (UMLS CUI [4,3])
C1512714 (UMLS CUI [5,1])
C0018823 (UMLS CUI [5,2])
C1510825 (UMLS CUI [6,1])
C0037435 (UMLS CUI [6,2])

Informed Consent

Item

willingness and ability to give written informed consent

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Pregnancy | Childbearing Potential

Item

pregnant or potentially child-bearing women

boolean

C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])

Echogenicity Poor

Item

patients with poor echogenicity

boolean

C1719852 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])

Left ventricular aneurysm

Item

left ventricular aneurysm

boolean

C0519097 (UMLS CUI [1])

Item

contra-indication to immunosuppressive drugs (history of cancer, infections like b or c hepatitis, positivity for hepatitis-b, hiv, htlv1)

boolean

C1301624 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0455471 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0856706 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
C1608390 (UMLS CUI [7])

Medical contraindication Sternotomy

Item

contra-indication to sternotomy

boolean

C1301624 (UMLS CUI [1,1])
C0185792 (UMLS CUI [1,2])

Alloimmunisation Against Cell line Progenitor cells

Item

alloimmunisation against the cell line from which the progenitors are derived

boolean

C0948201 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0682523 (UMLS CUI [1,3])
C0038250 (UMLS CUI [1,4])

Shock, Cardiogenic | Heart failure New York Heart Association Classification | Patient need for Pharmaceutical Preparations Intravenous

Item

cardiogenic shock or nyha class iv heart failure requiring need for intravenous drugs

boolean

C0036980 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])

Mental deterioration Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Mental deterioration Interferes with Follow-up | Mental disorder Interferes with Follow-up

Item

intellectual deterioration or psychiatric disease interfering with the ability to obtain an informed consent and to achieve a close follow-up of the patient

boolean

C0234985 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0234985 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])

Disease Reducing Life Expectancy | Exception Heart Disease

Item

noncardiac disease which may reduce life expectancy in the short term

boolean

C0012634 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])

Study Subject Participation Status | Clinical Trial

Item

simultaneous participation to another trial

boolean

C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])

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Eligibility Ischemic Heart Disease NCT02057900