0 Evaluaciones
ID

21153

Descripción

Cell Therapy in Chronic Ischemic Heart Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00362388

Link

https://clinicaltrials.gov/show/NCT00362388

Palabras clave

Versiones (1)
  1. 12/4/17 12/4/17 -
Subido en

12 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Ischemic Heart Disease NCT00362388

    Inglés

    Eligibility Ischemic Heart Disease NCT00362388

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (cad) referred for cabg.
    Descripción

    Diffuse disease of coronary artery severe chronic | Coronary Artery Disease Vessel atherosclerotic multiple | Coronary Artery Bypass Surgery

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1299384 (Diffuse disease of coronary artery)
    SNOMED
    371915000
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [1,3]
    C0205191 (chronic)
    SNOMED
    90734009
    UMLS CUI [2,1]
    C1956346 (Coronary Artery Disease)
    SNOMED
    53741008
    UMLS CUI [2,2]
    C0005847 (Blood Vessel)
    SNOMED
    59820001
    LOINC
    LP220354-7
    UMLS CUI [2,3]
    C0333482 (atherosclerotic)
    UMLS CUI [2,4]
    C0439064 (Numerous)
    SNOMED
    255204007
    LOINC
    LP7748-9
    UMLS CUI [3]
    C0010055 (Coronary Artery Bypass Surgery)
    SNOMED
    67166004
    LOINC
    LA14276-2
    echocardiogram-assessed lvef between 25 and 55% (simpson's rule).
    Descripción

    Left ventricular ejection fraction Echocardiography

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    UMLS CUI [1,2]
    C0013516 (Echocardiography)
    SNOMED
    40701008
    LOINC
    LP6171-5
    angina (or equivalent) functional class ii to iv (canadian cardiovascular society) despite maximally tolerated medical therapy.
    Descripción

    Angina Pectoris Canadian Cardiovascular Society classification | Therapeutic procedure Maximum Tolerated Dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0002962 (Angina Pectoris)
    SNOMED
    194828000
    UMLS CUI [1,2]
    C1277207 (Canadian Cardiovascular Society classification of angina)
    SNOMED
    134438001
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0752079 (Maximum Tolerated Dose)
    abnormal myocardial perfusion tests:
    Descripción

    Myocardial perfusion study Abnormal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0841688 (myocardial perfusion study)
    UMLS CUI [1,2]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    i. cardiac scintigraphy ii. magnetic resonance imaging iii. dobutamine-atropine stress-echocardiogram
    Descripción

    Scintigraphy cardiac | Magnetic Resonance Imaging | Echocardiography, Stress, Dobutamine | Atropine Echocardiography, Stress

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0034606 (Radionuclide Imaging)
    SNOMED
    373205008
    UMLS CUI [1,2]
    C0018787 (Heart)
    SNOMED
    80891009
    LOINC
    LP7289-4
    UMLS CUI [2]
    C0024485 (Magnetic Resonance Imaging)
    SNOMED
    312250003
    LOINC
    LP57602-2
    UMLS CUI [3]
    C0949700 (Echocardiography, Stress, Dobutamine)
    UMLS CUI [4,1]
    C0004259 (atropine)
    SNOMED
    73949004
    UMLS CUI [4,2]
    C0920208 (Echocardiography, Stress)
    SNOMED
    816996009
    LOINC
    LA28649-4
    non-candidates for a percutaneous coronary intervention (pci) due to any of the following:
    Descripción

    Percutaneous Coronary Intervention

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1532338 (Percutaneous Coronary Intervention)
    SNOMED
    415070008
    i. high risk lesion ii. extensive lesion iii. diffuse, small vessel disease
    Descripción

    Lesion High risk | Extensive Stage Lesion | Small-vessel disease Diffuse

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198 (Lesion)
    SNOMED
    52988006
    UMLS CUI [1,2]
    C0332167 (High risk of)
    SNOMED
    15508007
    UMLS CUI [2]
    C1333487 (Extensive Stage Lesion)
    UMLS CUI [3,1]
    C3810309 (undefined)
    UMLS CUI [3,2]
    C0205219 (Diffuse)
    SNOMED
    19648000
    LOINC
    LA15824-8
    non-candidates for a complete cabg, or candidates for a complete cabg in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
    Descripción

    Coronary Artery Bypass Surgery Complete | Graft failure Probability High | Severity of illness | Involvement Small-vessel disease Diffuse

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0010055 (Coronary Artery Bypass Surgery)
    SNOMED
    67166004
    LOINC
    LA14276-2
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,1]
    C1262018 (Graft failure)
    UMLS CUI [2,2]
    C0033204 (Probability)
    LOINC
    LA12746-6
    UMLS CUI [2,3]
    C0205250 (High)
    SNOMED
    75540009
    UMLS CUI [3]
    C0521117 (Severity of illness)
    UMLS CUI [4,1]
    C1314939 (Involvement with)
    SNOMED
    248448006
    LOINC
    LA26536-5
    UMLS CUI [4,2]
    C3810309 (undefined)
    UMLS CUI [4,3]
    C0205219 (Diffuse)
    SNOMED
    19648000
    LOINC
    LA15824-8
    to provide a signed, written informed consent, according to the national guidelines for clinical trials.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    severe valve heart disease requiring surgical repair.
    Descripción

    Heart valve disease Severe | Surgical repair Patient need for

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018824 (Heart valve disease)
    SNOMED
    368009
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,1]
    C0374711 (Surgical repair)
    SNOMED
    257903006
    UMLS CUI [2,2]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    serologic diagnostic of chagas' disease.
    Descripción

    Chagas Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0041234 (Chagas Disease)
    SNOMED
    77506005
    symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
    Descripción

    Heart failure Symptoms | Etiology aspects Ischemic | Myocardial Ischemia Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [1,2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [2,1]
    C0015127 (Etiology aspects)
    UMLS CUI [2,2]
    C0475224 (Ischemic)
    SNOMED
    255426005
    UMLS CUI [3,1]
    C0151744 (Myocardial Ischemia)
    SNOMED
    414545008
    UMLS CUI [3,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    malignant ventricular arrhythmias (like vt), unless an icd have been placed.
    Descripción

    Ventricular arrhythmia Malignant | Tachycardia, Ventricular | Implantable defibrillator Placement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0085612 (Ventricular arrhythmia)
    SNOMED
    44103008
    UMLS CUI [1,2]
    C0205282 (Malignant - descriptor)
    SNOMED
    21594007
    LOINC
    LP100607-3
    UMLS CUI [2]
    C0042514 (Tachycardia, Ventricular)
    SNOMED
    6624005
    UMLS CUI [3,1]
    C0162589 (Implantable defibrillator)
    SNOMED
    72506001
    UMLS CUI [3,2]
    C0589567 (Placement procedure)
    SNOMED
    312052002
    any acute coronary syndrome in the past 3 months.
    Descripción

    Acute Coronary Syndrome

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0948089 (Acute Coronary Syndrome)
    SNOMED
    394659003
    end-stage renal disease requiring maintenance dialysis.
    Descripción

    Kidney Failure, Chronic | Maintenance Dialysis Patient need for

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0022661 (Kidney Failure, Chronic)
    SNOMED
    46177005
    LOINC
    LP146090-8
    UMLS CUI [2,1]
    C0024501 (Maintenance)
    UMLS CUI [2,2]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [2,3]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    history of neoplasia.
    Descripción

    Neoplastic disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1882062 (Neoplastic disease)
    SNOMED
    55342001
    LOINC
    MTHU052369
    drug or alcohol abuse.
    Descripción

    Substance Use Disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    life expectancy below 2 years.
    Descripción

    Life Expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    enrollment in any cell therapy trial in the past 2 years.
    Descripción

    Study Subject Participation Status | Cell Therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2]
    C0302189 (Cell Therapy)
    LOINC
    LP101793-0
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    Similar models

    Eligibility Ischemic Heart Disease NCT00362388

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse disease of coronary artery severe chronic | Coronary Artery Disease Vessel atherosclerotic multiple | Coronary Artery Bypass Surgery
    Item
    diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (cad) referred for cabg.
    boolean
    C1299384 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C1956346 (UMLS CUI [2,1])
    C0005847 (UMLS CUI [2,2])
    C0333482 (UMLS CUI [2,3])
    C0439064 (UMLS CUI [2,4])
    C0010055 (UMLS CUI [3])
    Left ventricular ejection fraction Echocardiography
    Item
    echocardiogram-assessed lvef between 25 and 55% (simpson's rule).
    boolean
    C0428772 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Angina Pectoris Canadian Cardiovascular Society classification | Therapeutic procedure Maximum Tolerated Dose
    Item
    angina (or equivalent) functional class ii to iv (canadian cardiovascular society) despite maximally tolerated medical therapy.
    boolean
    C0002962 (UMLS CUI [1,1])
    C1277207 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0752079 (UMLS CUI [2,2])
    Myocardial perfusion study Abnormal
    Item
    abnormal myocardial perfusion tests:
    boolean
    C0841688 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    Scintigraphy cardiac | Magnetic Resonance Imaging | Echocardiography, Stress, Dobutamine | Atropine Echocardiography, Stress
    Item
    i. cardiac scintigraphy ii. magnetic resonance imaging iii. dobutamine-atropine stress-echocardiogram
    boolean
    C0034606 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0024485 (UMLS CUI [2])
    C0949700 (UMLS CUI [3])
    C0004259 (UMLS CUI [4,1])
    C0920208 (UMLS CUI [4,2])
    Percutaneous Coronary Intervention
    Item
    non-candidates for a percutaneous coronary intervention (pci) due to any of the following:
    boolean
    C1532338 (UMLS CUI [1])
    Lesion High risk | Extensive Stage Lesion | Small-vessel disease Diffuse
    Item
    i. high risk lesion ii. extensive lesion iii. diffuse, small vessel disease
    boolean
    C0221198 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C1333487 (UMLS CUI [2])
    C3810309 (UMLS CUI [3,1])
    C0205219 (UMLS CUI [3,2])
    Coronary Artery Bypass Surgery Complete | Graft failure Probability High | Severity of illness | Involvement Small-vessel disease Diffuse
    Item
    non-candidates for a complete cabg, or candidates for a complete cabg in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
    boolean
    C0010055 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C1262018 (UMLS CUI [2,1])
    C0033204 (UMLS CUI [2,2])
    C0205250 (UMLS CUI [2,3])
    C0521117 (UMLS CUI [3])
    C1314939 (UMLS CUI [4,1])
    C3810309 (UMLS CUI [4,2])
    C0205219 (UMLS CUI [4,3])
    Informed Consent
    Item
    to provide a signed, written informed consent, according to the national guidelines for clinical trials.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Heart valve disease Severe | Surgical repair Patient need for
    Item
    severe valve heart disease requiring surgical repair.
    boolean
    C0018824 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0374711 (UMLS CUI [2,1])
    C0686904 (UMLS CUI [2,2])
    Chagas Disease
    Item
    serologic diagnostic of chagas' disease.
    boolean
    C0041234 (UMLS CUI [1])
    Heart failure Symptoms | Etiology aspects Ischemic | Myocardial Ischemia Absent
    Item
    symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
    boolean
    C0018801 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [2,1])
    C0475224 (UMLS CUI [2,2])
    C0151744 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Ventricular arrhythmia Malignant | Tachycardia, Ventricular | Implantable defibrillator Placement
    Item
    malignant ventricular arrhythmias (like vt), unless an icd have been placed.
    boolean
    C0085612 (UMLS CUI [1,1])
    C0205282 (UMLS CUI [1,2])
    C0042514 (UMLS CUI [2])
    C0162589 (UMLS CUI [3,1])
    C0589567 (UMLS CUI [3,2])
    Acute Coronary Syndrome
    Item
    any acute coronary syndrome in the past 3 months.
    boolean
    C0948089 (UMLS CUI [1])
    Kidney Failure, Chronic | Maintenance Dialysis Patient need for
    Item
    end-stage renal disease requiring maintenance dialysis.
    boolean
    C0022661 (UMLS CUI [1])
    C0024501 (UMLS CUI [2,1])
    C0011946 (UMLS CUI [2,2])
    C0686904 (UMLS CUI [2,3])
    Neoplastic disease
    Item
    history of neoplasia.
    boolean
    C1882062 (UMLS CUI [1])
    Substance Use Disorders
    Item
    drug or alcohol abuse.
    boolean
    C0038586 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy below 2 years.
    boolean
    C0023671 (UMLS CUI [1])
    Study Subject Participation Status | Cell Therapy
    Item
    enrollment in any cell therapy trial in the past 2 years.
    boolean
    C2348568 (UMLS CUI [1])
    C0302189 (UMLS CUI [2])
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