ID

17445

Beschreibung

Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF); ODM derived from: https://clinicaltrials.gov/show/NCT00643279

Link

https://clinicaltrials.gov/show/NCT00643279

Stichworte

Versionen (1)
  1. 14.09.16 14.09.16 -
Hochgeladen am

14. September 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Heart Failure NCT00643279

Englisch

Eligibility Heart Failure NCT00643279

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with heart failure classified as new york heart association (nyha) class iii and iv
Beschreibung

Heart failure | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blockers (arb), and beta-blocker for at least 3 months prior to the baseline evaluation
Beschreibung

Standard of Care Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0001645
subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
Beschreibung

Hospitalization Quantity Related Heart failure | Emergency department visit Quantity Related Heart failure | Intravenous therapy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0018801
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0018801
UMLS CUI [3,1]
C0455142
UMLS CUI [3,2]
C0686904
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
Beschreibung

Transplantation Probably | Hospitalization Until Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0750492
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1720302
UMLS CUI [2,3]
C0040732
subjects with severe copd or restrictive airway disease (recommended fev1 less than or equal to 1 liter or 50% predicted)
Beschreibung

Severe chronic obstructive pulmonary disease | airway disease restrictive | FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0740850
UMLS CUI [3]
C0748133
subjects who are on continuous positive inotropic therapy
Beschreibung

Therapeutic procedure Inotropic agent Positive Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0549178
subjects with known atrial or ventricular septal defects
Beschreibung

Atrial Septal Defects | Ventricular Septal Defects

Datentyp

boolean

Alias
UMLS CUI [1]
C0018817
UMLS CUI [2]
C0018818
subjects with mechanical right heart valves
Beschreibung

HEART-VALVE, MECHANICAL Right

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0493527
UMLS CUI [1,2]
C0205090
subjects with stenotic tricuspid or pulmonary valves
Beschreibung

Tricuspid Valve Stenosis | Pulmonary Valve Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0040963
UMLS CUI [2]
C0034089
subjects with a presently implanted non-compatible pacemaker or icd
Beschreibung

pacemaker implant Compatible | Implantable defibrillator Compatible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0848753
UMLS CUI [1,2]
C1524057
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C1524057
subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
Beschreibung

Cardiac Resynchronization Therapy Suboptimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1167956
UMLS CUI [1,2]
C2984009
subjects with a major cardiovascular event within 3 months prior to baseline evaluation
Beschreibung

Cardiovascular event Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
subjects with a severe non-cardiac condition limiting 6 month survival
Beschreibung

Condition Severe Limiting Survival time

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C2919552
subjects with a primary diagnosis of pulmonary artery hypertension
Beschreibung

Pulmonary Hypertension Principal diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0332137
subjects with serum creatinine greater than or equal to 3.5 mg/dl or on chronic renal dialysis
Beschreibung

Creatinine measurement, serum | Dialysis procedure chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0205191
subjects enrolled in concurrent studies that may confound the results of this study
Beschreibung

Study Subject Participation Status Interferes with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Inadequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205412
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Heart Failure NCT00643279

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
subjects with heart failure classified as new york heart association (nyha) class iii and iv
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Standard of Care Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists
Item
subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blockers (arb), and beta-blocker for at least 3 months prior to the baseline evaluation
boolean
C2936643 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
Hospitalization Quantity Related Heart failure | Emergency department visit Quantity Related Heart failure | Intravenous therapy Patient need for
Item
subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0018801 (UMLS CUI [2,4])
C0455142 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Transplantation Probably | Hospitalization Until Transplantation
Item
subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
boolean
C0040732 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1720302 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Severe chronic obstructive pulmonary disease | airway disease restrictive | FEV1
Item
subjects with severe copd or restrictive airway disease (recommended fev1 less than or equal to 1 liter or 50% predicted)
boolean
C0730607 (UMLS CUI [1])
C0740850 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
Therapeutic procedure Inotropic agent Positive Continuous
Item
subjects who are on continuous positive inotropic therapy
boolean
C0087111 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Atrial Septal Defects | Ventricular Septal Defects
Item
subjects with known atrial or ventricular septal defects
boolean
C0018817 (UMLS CUI [1])
C0018818 (UMLS CUI [2])
HEART-VALVE, MECHANICAL Right
Item
subjects with mechanical right heart valves
boolean
C0493527 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
Tricuspid Valve Stenosis | Pulmonary Valve Stenosis
Item
subjects with stenotic tricuspid or pulmonary valves
boolean
C0040963 (UMLS CUI [1])
C0034089 (UMLS CUI [2])
pacemaker implant Compatible | Implantable defibrillator Compatible
Item
subjects with a presently implanted non-compatible pacemaker or icd
boolean
C0848753 (UMLS CUI [1,1])
C1524057 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C1524057 (UMLS CUI [2,2])
Cardiac Resynchronization Therapy Suboptimal
Item
subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
boolean
C1167956 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
Cardiovascular event Major
Item
subjects with a major cardiovascular event within 3 months prior to baseline evaluation
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Condition Severe Limiting Survival time
Item
subjects with a severe non-cardiac condition limiting 6 month survival
boolean
C0348080 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C2919552 (UMLS CUI [1,4])
Pulmonary Hypertension Principal diagnosis
Item
subjects with a primary diagnosis of pulmonary artery hypertension
boolean
C0020542 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Creatinine measurement, serum | Dialysis procedure chronic
Item
subjects with serum creatinine greater than or equal to 3.5 mg/dl or on chronic renal dialysis
boolean
C0201976 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with research results
Item
subjects enrolled in concurrent studies that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Pregnancy | Childbearing Potential Contraceptive methods Inadequate
Item
women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video