ID

31003

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00620048

Nyckelord

Versioner (1)
  1. 2018-07-10 2018-07-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Myocardial Ischemia NCT00620048

Engelsk

Eligibility Myocardial Ischemia NCT00620048

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Heart failure Ischemic New York Heart Association Classification

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Patients Inappropriate Revascularization conventional

Datatyp

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.
Beskrivning

Left ventricular ejection fraction Echocardiography

Datatyp

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.
Beskrivning

Anatomy Coronary Coronary angiography | Coronary Artery Disease Inappropriate Standard Revascularization

Datatyp

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.
Beskrivning

Serum Brain natriuretic peptide measurement

Datatyp

boolean

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

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Coronary revascularisation Successful

Datatyp

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.
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

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

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

Datatyp

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+).
Beskrivning

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

Datatyp

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.
Beskrivning

Biventricular pacemaker insertion

Datatyp

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).
Beskrivning

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

Datatyp

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