ID

21153

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00362388

Nyckelord

Versioner (1)
  1. 2017-04-12 2017-04-12 -
Uppladdad den

12 april 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT00362388

Engelsk

Eligibility Ischemic Heart Disease NCT00362388

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299384
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0333482
UMLS CUI [2,4]
C0439064
UMLS CUI [3]
C0010055
echocardiogram-assessed lvef between 25 and 55% (simpson's rule).
Beskrivning

Left ventricular ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
angina (or equivalent) functional class ii to iv (canadian cardiovascular society) despite maximally tolerated medical therapy.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1277207
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0752079
abnormal myocardial perfusion tests:
Beskrivning

Myocardial perfusion study Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0841688
UMLS CUI [1,2]
C0205161
i. cardiac scintigraphy ii. magnetic resonance imaging iii. dobutamine-atropine stress-echocardiogram
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034606
UMLS CUI [1,2]
C0018787
UMLS CUI [2]
C0024485
UMLS CUI [3]
C0949700
UMLS CUI [4,1]
C0004259
UMLS CUI [4,2]
C0920208
non-candidates for a percutaneous coronary intervention (pci) due to any of the following:
Beskrivning

Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
i. high risk lesion ii. extensive lesion iii. diffuse, small vessel disease
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C1333487
UMLS CUI [3,1]
C3810309
UMLS CUI [3,2]
C0205219
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1262018
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205250
UMLS CUI [3]
C0521117
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C3810309
UMLS CUI [4,3]
C0205219
to provide a signed, written informed consent, according to the national guidelines for clinical trials.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe valve heart disease requiring surgical repair.
Beskrivning

Heart valve disease Severe | Surgical repair Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0374711
UMLS CUI [2,2]
C0686904
serologic diagnostic of chagas' disease.
Beskrivning

Chagas Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0041234
symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
Beskrivning

Heart failure Symptoms | Etiology aspects Ischemic | Myocardial Ischemia Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0475224
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0332197
malignant ventricular arrhythmias (like vt), unless an icd have been placed.
Beskrivning

Ventricular arrhythmia Malignant | Tachycardia, Ventricular | Implantable defibrillator Placement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205282
UMLS CUI [2]
C0042514
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C0589567
any acute coronary syndrome in the past 3 months.
Beskrivning

Acute Coronary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
end-stage renal disease requiring maintenance dialysis.
Beskrivning

Kidney Failure, Chronic | Maintenance Dialysis Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C0686904
history of neoplasia.
Beskrivning

Neoplastic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1882062
drug or alcohol abuse.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
life expectancy below 2 years.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
enrollment in any cell therapy trial in the past 2 years.
Beskrivning

Study Subject Participation Status | Cell Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0302189
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Similar models

Eligibility Ischemic Heart Disease NCT00362388

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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