ID

44754

Beschreibung

Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01782677

Link

https://clinicaltrials.gov/show/NCT01782677

Stichworte

Versionen (1)
  1. 16.11.21 16.11.21 - Dr. Christian Niklas
Rechteinhaber

see https://clinicaltrials.gov/show/NCT01782677

Hochgeladen am

16. November 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure NCT01782677

Deutsch Englisch

Eligibility NCT01782677

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility NCT01782677
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI [1]
C1512693
History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
Beschreibung

Heart failure NYHA recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [1,3]
C0332185
Stable clinical state within at least 4 weeks prior to inclusion.
Beschreibung

Stable clinical state recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0332185
Subject is equal to or more than 18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Left ventricular ejection fraction more than 45 percent evaluated by transthoracic echocardiography (Simpson's method)
Beschreibung

Left ventricular ejection fraction (Simpson's Method) level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4036566
UMLS CUI [1,2]
C0439792
Carotid body present in computed tomography of cervical vessels
Beschreibung

Carotid body present in cervical CTA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007277
UMLS CUI [1,2]
C1536105
UMLS CUI [1,3]
C0027530
History of exacerbated peripheral chemoreceptor sensitivity determined as greater than 0.6l per min per percent SpO2
Beschreibung

Exacerbated chemoreceptor sensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2611731
UMLS CUI [1,2]
C4086268
able and willing to give written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI [1]
C0680251
Heart-failure requiring hospitalization within 3 months prior to inclusion
Beschreibung

Heart-failure requiring hospitalization recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332185
unstable angina pectoris in the last 3 months
Beschreibung

Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
acute coronary syndrome in the last 3 months
Beschreibung

Acute Coronary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
Percutaneous coronary revascularization in the last 3 months
Beschreibung

Percutaneous coronary revascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0877341
Clinically signigicant infection in the last 3 months
Beschreibung

Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
Surgery under general anaesthesia in the last 3 months
Beschreibung

Surgery requiring general anesthesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0002915
history of stroke
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
Transient Ischemic Attack
Beschreibung

Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0007787
History of clinically significant chronic neurological disorder
Beschreibung

Chronic neurological disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0027765
history of heart transplant
Beschreibung

Heart transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
pregnancy or anticipation of pregnancy
Beschreibung

Pregnancy or anticipated pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
hemodialysis or peritoneal dialysis patients
Beschreibung

Hemodialysis Dialysis or Peritoneal Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0031139
UMLS CUI [2]
C0019004
Obstructive carotid atherosclerotic disease with >50 percent stenosis
Beschreibung

Carotid stenosis extent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0439792
COPD stage 3 and 4 according to GOLD 2007
Beschreibung

COPD stage (GOLD 2007)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C1306673
unable to perform the spiroergometric assessment
Beschreibung

Unable to perform spiroergometry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0037981
UMLS CUI [1,3]
C1299582
Any significant anomaly in additional investigation which may increase the risk of study procedure?
Beschreibung

Anomaly associated risk from study procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0199171
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Ähnliche Modelle

Eligibility NCT01782677

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility NCT01782677
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI [1])
Heart failure NYHA recently
Item
History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Stable clinical state recently
Item
Stable clinical state within at least 4 weeks prior to inclusion.
boolean
C0205360 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Age
Item
Subject is equal to or more than 18 years old
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction (Simpson's Method) level
Item
Left ventricular ejection fraction more than 45 percent evaluated by transthoracic echocardiography (Simpson's method)
boolean
C4036566 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
Carotid body present in cervical CTA
Item
Carotid body present in computed tomography of cervical vessels
boolean
C0007277 (UMLS CUI [1,1])
C1536105 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
Exacerbated chemoreceptor sensitivity
Item
History of exacerbated peripheral chemoreceptor sensitivity determined as greater than 0.6l per min per percent SpO2
boolean
C2611731 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
Informed Consent
Item
able and willing to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI [1])
Heart-failure requiring hospitalization recently
Item
Heart-failure requiring hospitalization within 3 months prior to inclusion
boolean
C0019993 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Angina, Unstable
Item
unstable angina pectoris in the last 3 months
boolean
C0002965 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome in the last 3 months
boolean
C0948089 (UMLS CUI [1])
Percutaneous coronary revascularization
Item
Percutaneous coronary revascularization in the last 3 months
boolean
C0877341 (UMLS CUI [1])
Infection
Item
Clinically signigicant infection in the last 3 months
boolean
C3714514 (UMLS CUI [1])
Surgery requiring general anesthesia
Item
Surgery under general anaesthesia in the last 3 months
boolean
C0543467 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Transient Ischemic Attack
Item
Transient Ischemic Attack
boolean
C0007787 (UMLS CUI [1])
Chronic neurological disorder
Item
History of clinically significant chronic neurological disorder
boolean
C0008679 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Heart transplant
Item
history of heart transplant
boolean
C0018823 (UMLS CUI [1])
Pregnancy or anticipated pregnancy
Item
pregnancy or anticipation of pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Hemodialysis Dialysis or Peritoneal Dialysis
Item
hemodialysis or peritoneal dialysis patients
boolean
C0031139 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Carotid stenosis extent
Item
Obstructive carotid atherosclerotic disease with >50 percent stenosis
boolean
C0007282 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
COPD stage (GOLD 2007)
Item
COPD stage 3 and 4 according to GOLD 2007
boolean
C0024117 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
Unable to perform spiroergometry
Item
unable to perform the spiroergometric assessment
boolean
C0015259 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Anomaly associated risk from study procedure
Item
Any significant anomaly in additional investigation which may increase the risk of study procedure?
boolean
C1704258 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,3])
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