ID

40502

Beschreibung

Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02057900

Link

https://clinicaltrials.gov/show/NCT02057900

Stichworte

Versionen (1)
  1. 27.04.20 27.04.20 -
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See clinicaltrials.gov

Hochgeladen am

27. April 2020

DOI

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Eligibility Ischemic Heart Disease NCT02057900

Englisch

Eligibility Ischemic Heart Disease NCT02057900

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 and less than 81 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
severe left ventricular systolic dysfunction with left ventricular ejection fraction (lvef) ≤ 35% as assessed by echocardiography or scintigraphy
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277187
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0034606
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
Beschreibung

Myocardial Infarction | Akinesia Residual Echocardiography | Involvement Segment Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0085623
UMLS CUI [2,2]
C1609982
UMLS CUI [2,3]
C0013516
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0441635
UMLS CUI [3,3]
C1265611
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
Beschreibung

New York Heart Association Classification | Standard of Care Optimal | Diuretics | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone receptor blockers

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C2698651
UMLS CUI [3]
C0012798
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0304516
UMLS CUI [6]
C2215699
previous implantation of an automatic internal defibrillator associated, whenever indicated, to ventricular resynchronization
Beschreibung

Implantation of internal cardiac defibrillator Associated with Cardiac Resynchronization Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273352
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1167956
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0018821
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0396849
UMLS CUI [3,2]
C0026266
UMLS CUI [3,3]
C0475224
UMLS CUI [4,1]
C0026268
UMLS CUI [4,2]
C0026266
UMLS CUI [4,3]
C0475224
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C0018823
UMLS CUI [6,1]
C1510825
UMLS CUI [6,2]
C0037435
willingness and ability to give written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or potentially child-bearing women
Beschreibung

Pregnancy | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
patients with poor echogenicity
Beschreibung

Echogenicity Poor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1719852
UMLS CUI [1,2]
C0542537
left ventricular aneurysm
Beschreibung

Left ventricular aneurysm

Datentyp

boolean

Alias
UMLS CUI [1]
C0519097
contra-indication to immunosuppressive drugs (history of cancer, infections like b or c hepatitis, positivity for hepatitis-b, hiv, htlv1)
Beschreibung

Medical contraindication Immunosuppressive Agents | History of cancer | Hepatitis B | Hepatitis C | Hepatitis B positive | HIV Seropositivity | HTLV-1 test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0021081
UMLS CUI [2]
C0455471
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0856706
UMLS CUI [6]
C0019699
UMLS CUI [7]
C1608390
contra-indication to sternotomy
Beschreibung

Medical contraindication Sternotomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0185792
alloimmunisation against the cell line from which the progenitors are derived
Beschreibung

Alloimmunisation Against Cell line Progenitor cells

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948201
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0682523
UMLS CUI [1,4]
C0038250
cardiogenic shock or nyha class iv heart failure requiring need for intravenous drugs
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1522726
intellectual deterioration or psychiatric disease interfering with the ability to obtain an informed consent and to achieve a close follow-up of the patient
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0234985
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0234985
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C3274571
noncardiac disease which may reduce life expectancy in the short term
Beschreibung

Disease Reducing Life Expectancy | Exception Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
simultaneous participation to another trial
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Ähnliche Modelle

Eligibility Ischemic Heart Disease NCT02057900

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
New York Heart Association Classification | Standard of Care Optimal | Diuretics | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone receptor blockers
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])
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])
Medical contraindication Immunosuppressive Agents | History of cancer | Hepatitis B | Hepatitis C | Hepatitis B positive | HIV Seropositivity | HTLV-1 test positive
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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