ID

31003

Description

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

Link

https://clinicaltrials.gov/show/NCT00620048

Keywords

  1. 7/10/18 7/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 10, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Myocardial Ischemia NCT00620048

Eligibility Myocardial Ischemia NCT00620048

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Heart failure Ischemic New York Heart Association Classification

Data type

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.
Description

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

Data type

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.
Description

Patients Inappropriate Revascularization conventional

Data type

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.
Description

Left ventricular ejection fraction Echocardiography

Data type

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.
Description

Anatomy Coronary Coronary angiography | Coronary Artery Disease Inappropriate Standard Revascularization

Data type

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.
Description

Serum Brain natriuretic peptide measurement

Data type

boolean

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

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.
Description

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

Data type

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.
Description

Coronary revascularisation Successful

Data type

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.
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

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

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

Data type

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+).
Description

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

Data type

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.
Description

Biventricular pacemaker insertion

Data type

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).
Description

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

Data type

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

Similar models

Eligibility Myocardial Ischemia NCT00620048

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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