ID

24718

Descrição

Endocardial Stem Cells Approach Efficacy; ODM derived from: https://clinicaltrials.gov/show/NCT00841958

Link

https://clinicaltrials.gov/show/NCT00841958

Palavras-chave

Versões (1)
  1. 14.08.17 14.08.17 -
Transferido a

14. August 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Myocardial Ischemia NCT00841958

Inglês

Eligibility Myocardial Ischemia NCT00841958

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women who are not of childbearing potential
Descrição

Childbearing Potential Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
age 21-75 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with cad, nyha and ccs angina iii-iv functional class
Descrição

Coronary Artery Disease | Angina Pectoris New York Heart Association Classification | Angina Pectoris Canadian Cardiovascular Society classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C1277207
lvef less than 35% measured by echocardiography or spect within three months of study entry
Descrição

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction SPECT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0040399
unsuitable for initial or repeated conventional revascularization (cabg or pci)
Descrição

Inappropriate Revascularization Initial | Inappropriate Revascularization Repeated | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548788
UMLS CUI [1,2]
C0581603
UMLS CUI [1,3]
C0205265
UMLS CUI [2,1]
C1548788
UMLS CUI [2,2]
C0581603
UMLS CUI [2,3]
C0205341
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
failure to provide informed consent.
Descrição

Informed Consent Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
plan for pci or cabg.
Descrição

Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C1301732
non-cardiac illness with a life expectancy of less than 3 year.
Descrição

Illness | Exception Heart Diseases | Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
Descrição

Condition Adherence to treatment plan Poor | Compliance behavior Poor | Substance Dependence | Mental disorders | No fixed abode

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0516958
UMLS CUI [1,3]
C0542537
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0542537
UMLS CUI [3]
C0038580
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0557219
previous heart, kidney, liver, or lung transplantation.
Descrição

Heart Transplantation | Kidney Transplantation | Transplantation of liver | Lung Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0022671
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0024128
current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
Descrição

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
recent acute myocardial infarction (ami) within 90 days of study entry
Descrição

Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
successful coronary revascularization (сabg or pci) within 12 months of study enrollment
Descrição

Coronary revascularisation Successful | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1272703
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
history of moderate to severe aortic stenosis or prosthetic aortic valve
Descrição

Aortic Valve Stenosis Moderate | Aortic stenosis, severe | Aortic valve prosthesis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C3806272
UMLS CUI [3]
C0182431
permanent atrial fibrillation
Descrição

Permanent atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2586056
thrombosis in lv, based on echocardiography data
Descrição

Left ventricular thrombosis Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0587044
UMLS CUI [1,2]
C0013516
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Eligibility Myocardial Ischemia NCT00841958

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Absent
Item
men and women who are not of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 21-75 years.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Angina Pectoris New York Heart Association Classification | Angina Pectoris Canadian Cardiovascular Society classification
Item
patients with cad, nyha and ccs angina iii-iv functional class
boolean
C1956346 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C1277207 (UMLS CUI [3,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction SPECT
Item
lvef less than 35% measured by echocardiography or spect within three months of study entry
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0040399 (UMLS CUI [2,2])
Inappropriate Revascularization Initial | Inappropriate Revascularization Repeated | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
unsuitable for initial or repeated conventional revascularization (cabg or pci)
boolean
C1548788 (UMLS CUI [1,1])
C0581603 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C1548788 (UMLS CUI [2,1])
C0581603 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
failure to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned
Item
plan for pci or cabg.
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Illness | Exception Heart Diseases | Life Expectancy
Item
non-cardiac illness with a life expectancy of less than 3 year.
boolean
C0221423 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Condition Adherence to treatment plan Poor | Compliance behavior Poor | Substance Dependence | Mental disorders | No fixed abode
Item
conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
boolean
C0348080 (UMLS CUI [1,1])
C0516958 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0038580 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0557219 (UMLS CUI [5])
Heart Transplantation | Kidney Transplantation | Transplantation of liver | Lung Transplantation
Item
previous heart, kidney, liver, or lung transplantation.
boolean
C0018823 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0024128 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Myocardial Infarction
Item
recent acute myocardial infarction (ami) within 90 days of study entry
boolean
C0027051 (UMLS CUI [1])
Coronary revascularisation Successful | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
successful coronary revascularization (сabg or pci) within 12 months of study enrollment
boolean
C0877341 (UMLS CUI [1,1])
C1272703 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Aortic Valve Stenosis Moderate | Aortic stenosis, severe | Aortic valve prosthesis
Item
history of moderate to severe aortic stenosis or prosthetic aortic valve
boolean
C0003507 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3806272 (UMLS CUI [2])
C0182431 (UMLS CUI [3])
Permanent atrial fibrillation
Item
permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
Left ventricular thrombosis Echocardiography
Item
thrombosis in lv, based on echocardiography data
boolean
C0587044 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
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