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ID

31003

Descrição

Stem Cell Study for Subjects With Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00620048

Link

https://clinicaltrials.gov/show/NCT00620048

Palavras-chave

Versões (1)
  1. 10/07/2018 10/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Myocardial Ischemia NCT00620048

    Inglês

    Eligibility Myocardial Ischemia NCT00620048

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects 21 to 80 years old (inclusive).
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    subjects with functional class (nyha) ii or iii ischemic heart failure.
    Descrição

    Heart failure Ischemic New York Heart Association Classification

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0475224
    UMLS CUI [1,3]
    C1275491
    subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ace)inhibitors without control of symptoms.
    Descrição

    Therapeutic procedure cardiac optimal | Nitrates Active Long-term | Adrenergic beta-Antagonists Maximal | Angiotensin-Converting Enzyme Inhibitors | Symptoms Uncontrolled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [1,3]
    C2698651
    UMLS CUI [2,1]
    C0028125
    UMLS CUI [2,2]
    C0205177
    UMLS CUI [2,3]
    C0443252
    UMLS CUI [3,1]
    C0001645
    UMLS CUI [3,2]
    C0205289
    UMLS CUI [4]
    C0003015
    UMLS CUI [5,1]
    C1457887
    UMLS CUI [5,2]
    C0205318
    subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
    Descrição

    Patients Inappropriate Revascularization conventional

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548788
    UMLS CUI [1,3]
    C0581603
    UMLS CUI [1,4]
    C0439858
    subjects must have left ventricular ejection fraction <40% by echocardiography.
    Descrição

    Left ventricular ejection fraction Echocardiography

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0428772
    UMLS CUI [1,2]
    C0013516
    all subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
    Descrição

    Anatomy Coronary Coronary angiography | Coronary Artery Disease Inappropriate Standard Revascularization

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0700276
    UMLS CUI [1,2]
    C1522318
    UMLS CUI [1,3]
    C0085532
    UMLS CUI [2,1]
    C1956346
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C1442989
    UMLS CUI [2,4]
    C0581603
    have serum b-type natriuretic peptide (bnp) level >100 pg/ml.
    Descrição

    Serum Brain natriuretic peptide measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0229671
    UMLS CUI [1,2]
    C1095989
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    myocardial infarction (q wave or non-q wave defined as ckmb >3 times normal) within 30 days of treatment.
    Descrição

    Myocardial Infarction | Q wave MI | Non-Q wave MI | CKMB Increased

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0861151
    UMLS CUI [3]
    C0860155
    UMLS CUI [4,1]
    C0010290
    UMLS CUI [4,2]
    C0205217
    successful coronary revascularization procedures within 3 months of study enrollment.
    Descrição

    Coronary revascularisation Successful

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0877341
    UMLS CUI [1,2]
    C1272703
    documented stroke or transient ischemic attack (tia) within 60 days of study enrollment.
    Descrição

    Cerebrovascular accident | Transient Ischemic Attack

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2]
    C0007787
    nyha class iv heart failure and patients with idiopathic or non-ischemic heart failure.
    Descrição

    Heart failure New York Heart Association Classification | Heart failure idiopathic | Heart failure Without Feature Ischemic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C1275491
    UMLS CUI [2,1]
    C0018801
    UMLS CUI [2,2]
    C0332240
    UMLS CUI [3,1]
    C0018801
    UMLS CUI [3,2]
    C0332288
    UMLS CUI [3,3]
    C2348519
    UMLS CUI [3,4]
    C0475224
    history of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
    Descrição

    Aortic stenosis, severe | Aortic valve area Size | Aortic Valve Insufficiency Severe | Mitral Valve Stenosis Severe | Mitral valve area Size | Mitral Valve Insufficiency Severe

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3806272
    UMLS CUI [2,1]
    C0428817
    UMLS CUI [2,2]
    C0456389
    UMLS CUI [3,1]
    C0003504
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [4,1]
    C0026269
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5,1]
    C0428818
    UMLS CUI [5,2]
    C0456389
    UMLS CUI [6,1]
    C0026266
    UMLS CUI [6,2]
    C0205082
    implantation of biventricular pacemaker within 90 days of study treatment.
    Descrição

    Biventricular pacemaker insertion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3805138
    severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
    Descrição

    Comorbidity Severe | Reduced life expectancy | Chronic disease | Severe chronic obstructive pulmonary disease | Kidney Failure | Malignant Neoplasms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C1858274
    UMLS CUI [3]
    C0008679
    UMLS CUI [4]
    C0730607
    UMLS CUI [5]
    C0035078
    UMLS CUI [6]
    C0006826
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    Similar models

    Eligibility Myocardial Ischemia NCT00620048

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    subjects 21 to 80 years old (inclusive).
    boolean
    C0001779 (UMLS CUI [1])
    Heart failure Ischemic New York Heart Association Classification
    Item
    subjects with functional class (nyha) ii or iii ischemic heart failure.
    boolean
    C0018801 (UMLS CUI [1,1])
    C0475224 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [1,3])
    Therapeutic procedure cardiac optimal | Nitrates Active Long-term | Adrenergic beta-Antagonists Maximal | Angiotensin-Converting Enzyme Inhibitors | Symptoms Uncontrolled
    Item
    subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ace)inhibitors without control of symptoms.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C2698651 (UMLS CUI [1,3])
    C0028125 (UMLS CUI [2,1])
    C0205177 (UMLS CUI [2,2])
    C0443252 (UMLS CUI [2,3])
    C0001645 (UMLS CUI [3,1])
    C0205289 (UMLS CUI [3,2])
    C0003015 (UMLS CUI [4])
    C1457887 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    Patients Inappropriate Revascularization conventional
    Item
    subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548788 (UMLS CUI [1,2])
    C0581603 (UMLS CUI [1,3])
    C0439858 (UMLS CUI [1,4])
    Left ventricular ejection fraction Echocardiography
    Item
    subjects must have left ventricular ejection fraction <40% by echocardiography.
    boolean
    C0428772 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Anatomy Coronary Coronary angiography | Coronary Artery Disease Inappropriate Standard Revascularization
    Item
    all subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
    boolean
    C0700276 (UMLS CUI [1,1])
    C1522318 (UMLS CUI [1,2])
    C0085532 (UMLS CUI [1,3])
    C1956346 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C1442989 (UMLS CUI [2,3])
    C0581603 (UMLS CUI [2,4])
    Serum Brain natriuretic peptide measurement
    Item
    have serum b-type natriuretic peptide (bnp) level >100 pg/ml.
    boolean
    C0229671 (UMLS CUI [1,1])
    C1095989 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Myocardial Infarction | Q wave MI | Non-Q wave MI | CKMB Increased
    Item
    myocardial infarction (q wave or non-q wave defined as ckmb >3 times normal) within 30 days of treatment.
    boolean
    C0027051 (UMLS CUI [1])
    C0861151 (UMLS CUI [2])
    C0860155 (UMLS CUI [3])
    C0010290 (UMLS CUI [4,1])
    C0205217 (UMLS CUI [4,2])
    Coronary revascularisation Successful
    Item
    successful coronary revascularization procedures within 3 months of study enrollment.
    boolean
    C0877341 (UMLS CUI [1,1])
    C1272703 (UMLS CUI [1,2])
    Cerebrovascular accident | Transient Ischemic Attack
    Item
    documented stroke or transient ischemic attack (tia) within 60 days of study enrollment.
    boolean
    C0038454 (UMLS CUI [1])
    C0007787 (UMLS CUI [2])
    Heart failure New York Heart Association Classification | Heart failure idiopathic | Heart failure Without Feature Ischemic
    Item
    nyha class iv heart failure and patients with idiopathic or non-ischemic heart failure.
    boolean
    C0018801 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    C0018801 (UMLS CUI [2,1])
    C0332240 (UMLS CUI [2,2])
    C0018801 (UMLS CUI [3,1])
    C0332288 (UMLS CUI [3,2])
    C2348519 (UMLS CUI [3,3])
    C0475224 (UMLS CUI [3,4])
    Aortic stenosis, severe | Aortic valve area Size | Aortic Valve Insufficiency Severe | Mitral Valve Stenosis Severe | Mitral valve area Size | Mitral Valve Insufficiency Severe
    Item
    history of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
    boolean
    C3806272 (UMLS CUI [1])
    C0428817 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    C0003504 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0026269 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0428818 (UMLS CUI [5,1])
    C0456389 (UMLS CUI [5,2])
    C0026266 (UMLS CUI [6,1])
    C0205082 (UMLS CUI [6,2])
    Biventricular pacemaker insertion
    Item
    implantation of biventricular pacemaker within 90 days of study treatment.
    boolean
    C3805138 (UMLS CUI [1])
    Comorbidity Severe | Reduced life expectancy | Chronic disease | Severe chronic obstructive pulmonary disease | Kidney Failure | Malignant Neoplasms
    Item
    severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1858274 (UMLS CUI [2])
    C0008679 (UMLS CUI [3])
    C0730607 (UMLS CUI [4])
    C0035078 (UMLS CUI [5])
    C0006826 (UMLS CUI [6])
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