ID

39534

Beschreibung

VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02113033

Link

https://clinicaltrials.gov/show/NCT02113033

Stichworte

Versionen (1)
  1. 24.01.20 24.01.20 -
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See clinicaltrials.gov

Hochgeladen am

24. Januar 2020

DOI

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Eligibility Heart Failure With Reduced Ejection Fraction NCT02113033

Englisch

Eligibility Heart Failure With Reduced Ejection Fraction NCT02113033

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by lvef < 40%
Beschreibung

Ventricular Dysfunction, Left | Etiology Ischemic cardiomyopathy | Etiology Idiopathic dilated cardiomyopathy | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0349782
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1449563
UMLS CUI [4]
C0428772
2. chronic heart failure with symptoms characterized by nyha functional class ii or iii at the time of enrollment despite optimal drug regimen
Beschreibung

Chronic heart failure Symptoms New York Heart Association Classification | Pharmacotherapy Optimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C2698651
3. optimal drug regimen as defined in the current european guidelines
Beschreibung

Pharmacotherapy Optimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
4. sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
Beschreibung

Sinus rhythm | Heart rate Spontaneous beats per minute

Datentyp

boolean

Alias
UMLS CUI [1]
C0232201
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0205359
UMLS CUI [2,3]
C0439385
5. signed and dated informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
main exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patient implanted with or eligible to cardiac pacing as per current guideline
Beschreibung

Cardiac pacing Implanted | Eligibility Cardiac pacing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199640
UMLS CUI [1,2]
C0021102
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0199640
risk for neck surgery in the electrode zone within a year after enrollment
Beschreibung

At risk Operation on neck

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0185773
patient with right carotid artery stenosis
Beschreibung

Right carotid artery stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C3531770
symptomatic hypotension
Beschreibung

Hypotension symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0863113
history of peptic ulcer disease or upper gastrointestinal bleeding
Beschreibung

Peptic Ulcer | Upper gastrointestinal hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
asthma, severe copd, or severe restrictive lung disease
Beschreibung

Asthma | Severe chronic obstructive pulmonary disease | Restrictive lung disease Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0730607
UMLS CUI [3,1]
C0085581
UMLS CUI [3,2]
C0205082
advanced diabetes mellitus
Beschreibung

Diabetes Mellitus Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205179
recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
Beschreibung

Recent myocardial infarction | Operative procedure on coronary artery | Revascularization | Operative procedure on coronary artery Planned | Revascularization Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C1998297
UMLS CUI [2]
C0190188
UMLS CUI [3]
C0581603
UMLS CUI [4,1]
C0190188
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0581603
UMLS CUI [5,2]
C1301732
recent cerebro-vascular event
Beschreibung

Event Cerebrovascular Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
UMLS CUI [1,3]
C0332185
significant valvulopathy
Beschreibung

Valvular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C3258293
advanced renal failure
Beschreibung

Kidney Failure Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205179
previous heart transplant or current lvad device therapy
Beschreibung

Heart Transplantation Previous | Implantation of left ventricular assist device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0397130
life expectancy < 1 year for non-cardiac cause
Beschreibung

Life Expectancy | Etiology Except Heart Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0018799
patient included in another clinical study that could confound the results of this study
Beschreibung

Study Subject Participation Status | Clinical Trial Interferes with Research results

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
inability to understand the purpose of the study or to perform the procedures of the study
Beschreibung

Study Protocol Comprehension Unable | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
unavailability for scheduled follow-up
Beschreibung

Patient Unavailable Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0686905
UMLS CUI [1,3]
C3274571
age of less than 18 years or under guardianship
Beschreibung

Age | Patient Guardianship

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0870627
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Heart Failure With Reduced Ejection Fraction NCT02113033

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Ventricular Dysfunction, Left | Etiology Ischemic cardiomyopathy | Etiology Idiopathic dilated cardiomyopathy | Left ventricular ejection fraction
Item
1. left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by lvef < 40%
boolean
C0242698 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0349782 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1449563 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4])
Chronic heart failure Symptoms New York Heart Association Classification | Pharmacotherapy Optimal
Item
2. chronic heart failure with symptoms characterized by nyha functional class ii or iii at the time of enrollment despite optimal drug regimen
boolean
C0264716 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Pharmacotherapy Optimal
Item
3. optimal drug regimen as defined in the current european guidelines
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Sinus rhythm | Heart rate Spontaneous beats per minute
Item
4. sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
boolean
C0232201 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0439385 (UMLS CUI [2,3])
Informed Consent
Item
5. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cardiac pacing Implanted | Eligibility Cardiac pacing
Item
patient implanted with or eligible to cardiac pacing as per current guideline
boolean
C0199640 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0199640 (UMLS CUI [2,2])
At risk Operation on neck
Item
risk for neck surgery in the electrode zone within a year after enrollment
boolean
C1444641 (UMLS CUI [1,1])
C0185773 (UMLS CUI [1,2])
Right carotid artery stenosis
Item
patient with right carotid artery stenosis
boolean
C3531770 (UMLS CUI [1])
Hypotension symptomatic
Item
symptomatic hypotension
boolean
C0863113 (UMLS CUI [1])
Peptic Ulcer | Upper gastrointestinal hemorrhage
Item
history of peptic ulcer disease or upper gastrointestinal bleeding
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
Asthma | Severe chronic obstructive pulmonary disease | Restrictive lung disease Severe
Item
asthma, severe copd, or severe restrictive lung disease
boolean
C0004096 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
C0085581 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Diabetes Mellitus Advanced
Item
advanced diabetes mellitus
boolean
C0011849 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Recent myocardial infarction | Operative procedure on coronary artery | Revascularization | Operative procedure on coronary artery Planned | Revascularization Planned
Item
recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
boolean
C1998297 (UMLS CUI [1])
C0190188 (UMLS CUI [2])
C0581603 (UMLS CUI [3])
C0190188 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0581603 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
Event Cerebrovascular Recent
Item
recent cerebro-vascular event
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Valvular disease
Item
significant valvulopathy
boolean
C3258293 (UMLS CUI [1])
Kidney Failure Advanced
Item
advanced renal failure
boolean
C0035078 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Heart Transplantation Previous | Implantation of left ventricular assist device
Item
previous heart transplant or current lvad device therapy
boolean
C0018823 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0397130 (UMLS CUI [2])
Life Expectancy | Etiology Except Heart Diseases
Item
life expectancy < 1 year for non-cardiac cause
boolean
C0023671 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0018799 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial Interferes with Research results
Item
patient included in another clinical study that could confound the results of this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Study Protocol Comprehension Unable | Protocol Compliance Unable
Item
inability to understand the purpose of the study or to perform the procedures of the study
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Patient Unavailable Follow-up
Item
unavailability for scheduled follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Age | Patient Guardianship
Item
age of less than 18 years or under guardianship
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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