ID

39600

Beschreibung

Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home; ODM derived from: https://clinicaltrials.gov/show/NCT00946231

Link

https://clinicaltrials.gov/show/NCT00946231

Stichworte

Versionen (1)
  1. 02.02.20 02.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Februar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT00946231

Englisch

Eligibility Heart Failure NCT00946231

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults (18 years of age or older);
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
admitted to the hospital or observation unit with a diagnosis of decompensated hf for which treatment will be administered;
Beschreibung

Hospital admission | Decompensated cardiac failure Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1]
C0184666
UMLS CUI [2,1]
C0581377
UMLS CUI [2,2]
C0332121
blood bnp level measurement > 400 pg/ml documented during admission; if nt-probnp is used routinely in the laboratory at a clinical site rather than bnp, then blood nt-probnp level measurement > 1,600 pg/ml documented during admission.
Beschreibung

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
successfully trained on how to perform a fingerstick and to use the triage touch.
Beschreibung

Blood glucose determination by fingerstick Perform Successful | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2022094
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C1272703
UMLS CUI [2]
C3846158
either the subject or their care provider is fluent in reading and writing english
Beschreibung

Able to read Well English Language | Able to write Well English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0205170
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0205170
UMLS CUI [2,3]
C0376245
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwilling or unable to provide written informed consent;
Beschreibung

Informed Consent Unwilling | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
acute coronary syndrome (acs) that is concomitant with the diagnosis of decompensated hf and for which treatment will be provided.
Beschreibung

Acute Coronary Syndrome Associated with Decompensated cardiac failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0581377
a history of acs is not reason for exclusion if it is not concomitant with the present decompensated hf for which admission is being made. small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated hf and not due to a concomitant acs or myocardial infarction are not a basis for exclusion.
Beschreibung

Exception Acute Coronary Syndrome Without Decompensated cardiac failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0948089
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0581377
previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
Beschreibung

Heart Transplantation Previous | Heart Transplantation Anticipated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C3840775
current or planned use of a left ventricular assist device (lvad), use of outpatient intravenous inotropic hf therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
Beschreibung

Left ventricular assist device | Inotropic agent Intravenous Heart failure | Major surgery | Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C0181598
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0018801
UMLS CUI [3]
C0679637
UMLS CUI [4]
C1532338
life expectancy less than 3 months due to causes other than hf or cardiovascular disease (e.g., cancer);
Beschreibung

Life Expectancy | Etiology Except Heart failure | Etiology Except Cardiovascular Disease | Etiology Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0018801
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0007222
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0006826
end stage renal disease;
Beschreibung

Kidney Failure, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0022661
prisoner or other institutionalized or vulnerable individual;
Beschreibung

Prisoners | Institutionalized Persons | Vulnerable Populations

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2]
C0376326
UMLS CUI [3]
C0949366
residence in regions where either transmission of triage touch data or a home visit on day 5 is not possible.
Beschreibung

Residence Geographic Factor | Data Transmission Unsuccessful | Home visit Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0017444
UMLS CUI [2,1]
C0332289
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0020043
UMLS CUI [3,2]
C1272705
dementia, tremors or other impediments to performing daily home bnp testing via fingerstick.
Beschreibung

Dementia | Tremor | BNP measurement Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0040822
UMLS CUI [3,1]
C1095989
UMLS CUI [3,2]
C1272705
deemed by the investigator not to be likely to comply with study-mandated procedures or instructions.
Beschreibung

Protocol Compliance Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
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Ähnliche Modelle

Eligibility Heart Failure NCT00946231

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults (18 years of age or older);
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hospital admission | Decompensated cardiac failure Treatment required for
Item
admitted to the hospital or observation unit with a diagnosis of decompensated hf for which treatment will be administered;
boolean
C0184666 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
blood bnp level measurement > 400 pg/ml documented during admission; if nt-probnp is used routinely in the laboratory at a clinical site rather than bnp, then blood nt-probnp level measurement > 1,600 pg/ml documented during admission.
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Blood glucose determination by fingerstick Perform Successful | Other Coding
Item
successfully trained on how to perform a fingerstick and to use the triage touch.
boolean
C2022094 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Able to read Well English Language | Able to write Well English Language
Item
either the subject or their care provider is fluent in reading and writing english
boolean
C0586740 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0584993 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling or unable to provide written informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Acute Coronary Syndrome Associated with Decompensated cardiac failure
Item
acute coronary syndrome (acs) that is concomitant with the diagnosis of decompensated hf and for which treatment will be provided.
boolean
C0948089 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,3])
Exception Acute Coronary Syndrome Without Decompensated cardiac failure
Item
a history of acs is not reason for exclusion if it is not concomitant with the present decompensated hf for which admission is being made. small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated hf and not due to a concomitant acs or myocardial infarction are not a basis for exclusion.
boolean
C1705847 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0581377 (UMLS CUI [1,4])
Heart Transplantation Previous | Heart Transplantation Anticipated
Item
previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
boolean
C0018823 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Left ventricular assist device | Inotropic agent Intravenous Heart failure | Major surgery | Percutaneous Coronary Intervention
Item
current or planned use of a left ventricular assist device (lvad), use of outpatient intravenous inotropic hf therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
boolean
C0181598 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
C0679637 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
Life Expectancy | Etiology Except Heart failure | Etiology Except Cardiovascular Disease | Etiology Malignant Neoplasms
Item
life expectancy less than 3 months due to causes other than hf or cardiovascular disease (e.g., cancer);
boolean
C0023671 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0007222 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
Kidney Failure, Chronic
Item
end stage renal disease;
boolean
C0022661 (UMLS CUI [1])
Prisoners | Institutionalized Persons | Vulnerable Populations
Item
prisoner or other institutionalized or vulnerable individual;
boolean
C0033167 (UMLS CUI [1])
C0376326 (UMLS CUI [2])
C0949366 (UMLS CUI [3])
Residence Geographic Factor | Data Transmission Unsuccessful | Home visit Unsuccessful
Item
residence in regions where either transmission of triage touch data or a home visit on day 5 is not possible.
boolean
C0237096 (UMLS CUI [1,1])
C0017444 (UMLS CUI [1,2])
C0332289 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0020043 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Dementia | Tremor | BNP measurement Unsuccessful
Item
dementia, tremors or other impediments to performing daily home bnp testing via fingerstick.
boolean
C0497327 (UMLS CUI [1])
C0040822 (UMLS CUI [2])
C1095989 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Protocol Compliance Unlikely
Item
deemed by the investigator not to be likely to comply with study-mandated procedures or instructions.
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
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