ID

36133

Descrição

Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02346045

Link

https://clinicaltrials.gov/show/NCT02346045

Palavras-chave

Versões (1)
  1. 17/04/2019 17/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT02346045

Inglês

Eligibility Hypertension NCT02346045

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are under hemodialysis due to end stage renal disease
Descrição

Hemodialysis Due to End stage renal disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0022661
patients who have resistant hypertension with office sbp >160 mmhg)
Descrição

HYPERTENSION RESISTANT | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745130
UMLS CUI [2]
C0871470
patients who are or over 18 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients who submit informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known secondary hypertension patients
Descrição

Secondary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
patients who have renal artery which is not adequate for renal denervation
Descrição

Renal artery Inadequate Renal artery denervation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C3544270
1. the main renal artery diameter < 4 mm, or renal artery length < 20 mm
Descrição

Renal artery Main Diameter | Renal artery Length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1301886
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1444754
2. the renal arteries into which stable catheter insertion is difficulty and which have hemodynamically or anatomically significant stenosis
Descrição

Structure of renal artery Catheterization Difficult | Renal Artery Stenosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0007430
UMLS CUI [1,3]
C0332218
UMLS CUI [2]
C0035067
3. the renal arteries who have undergone renal angioplasty
Descrição

Renal arteries Angioplasty

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1282893
patients who have history of myocardial infarction, unstable angina, syncope cerebrovascular insufficiency or extensive atherosclerotic disease with intravascular thrombosis, or unstable plaque
Descrição

Myocardial Infarction | Angina, Unstable | Syncope | Cerebrovascular Insufficiency | Atherosclerosis Extensive | Intravascular thrombosis | Plaque Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0039070
UMLS CUI [4]
C0241832
UMLS CUI [5,1]
C0004153
UMLS CUI [5,2]
C0205231
UMLS CUI [6]
C0442860
UMLS CUI [7,1]
C2936350
UMLS CUI [7,2]
C0443343
type 1 diabetes
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
patients who have scheduled percutaneous coronary intervention (pci) or operation within 6 months
Descrição

Percutaneous Coronary Intervention Scheduled | Operative Surgical Procedures Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205539
hemodynamically significant valvular heart disease in which blood pressure reduction may cause significant deterioration of patient's health.
Descrição

Heart valve disease | Blood Pressure Reduction Causing Deteriorating condition of patient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0555790
primary pulmonary hypertension
Descrição

Primary pulmonary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152171
patients who have the intracardiac defibrillator(icd) or pacemaker which do not allow delivery of radiofrequency energy.
Descrição

ICD | Artificial cardiac pacemaker

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0030163
patients who require continuous oxygen supply or mechanical ventilation for treatment of obstructive sleep apnea
Descrição

Oxygen supplementation Obstructive Sleep Apnea | Mechanical ventilation Obstructive Sleep Apnea

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0919655
UMLS CUI [1,2]
C0520679
UMLS CUI [2,1]
C0199470
UMLS CUI [2,2]
C0520679
patients who have serious medical condition which can compromise the safety of the patients and the safety and integrity of the study.
Descrição

Medical condition Serious compromises Patient safety | Medical condition compromises Integrity Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1947912
UMLS CUI [2,4]
C0008976
patients who have unresolved drug issue, alcoholism
Descrição

Drug use issue | Alcoholic Intoxication, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4049580
UMLS CUI [2]
C0001973
patients who lack ability to understand and follow the instruction the researcher
Descrição

Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
patient who cannot follow up
Descrição

Follow-up Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
patients who are registered in other trial
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
patients who are pregnant, nursing or planning to be pregnant
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Hypertension NCT02346045

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hemodialysis Due to End stage renal disease
Item
patients who are under hemodialysis due to end stage renal disease
boolean
C0019004 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0022661 (UMLS CUI [1,3])
HYPERTENSION RESISTANT | Systolic Pressure
Item
patients who have resistant hypertension with office sbp >160 mmhg)
boolean
C0745130 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Age
Item
patients who are or over 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients who submit informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
known secondary hypertension patients
boolean
C0155616 (UMLS CUI [1])
Renal artery Inadequate Renal artery denervation
Item
patients who have renal artery which is not adequate for renal denervation
boolean
C0035065 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C3544270 (UMLS CUI [1,3])
Renal artery Main Diameter | Renal artery Length
Item
1. the main renal artery diameter < 4 mm, or renal artery length < 20 mm
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0035065 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
Structure of renal artery Catheterization Difficult | Renal Artery Stenosis
Item
2. the renal arteries into which stable catheter insertion is difficulty and which have hemodynamically or anatomically significant stenosis
boolean
C0035065 (UMLS CUI [1,1])
C0007430 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0035067 (UMLS CUI [2])
Renal arteries Angioplasty
Item
3. the renal arteries who have undergone renal angioplasty
boolean
C0035065 (UMLS CUI [1,1])
C1282893 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Syncope | Cerebrovascular Insufficiency | Atherosclerosis Extensive | Intravascular thrombosis | Plaque Unstable
Item
patients who have history of myocardial infarction, unstable angina, syncope cerebrovascular insufficiency or extensive atherosclerotic disease with intravascular thrombosis, or unstable plaque
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0039070 (UMLS CUI [3])
C0241832 (UMLS CUI [4])
C0004153 (UMLS CUI [5,1])
C0205231 (UMLS CUI [5,2])
C0442860 (UMLS CUI [6])
C2936350 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Percutaneous Coronary Intervention Scheduled | Operative Surgical Procedures Scheduled
Item
patients who have scheduled percutaneous coronary intervention (pci) or operation within 6 months
boolean
C1532338 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Heart valve disease | Blood Pressure Reduction Causing Deteriorating condition of patient
Item
hemodynamically significant valvular heart disease in which blood pressure reduction may cause significant deterioration of patient's health.
boolean
C0018824 (UMLS CUI [1])
C0005823 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0555790 (UMLS CUI [2,4])
Primary pulmonary hypertension
Item
primary pulmonary hypertension
boolean
C0152171 (UMLS CUI [1])
ICD | Artificial cardiac pacemaker
Item
patients who have the intracardiac defibrillator(icd) or pacemaker which do not allow delivery of radiofrequency energy.
boolean
C0162589 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Oxygen supplementation Obstructive Sleep Apnea | Mechanical ventilation Obstructive Sleep Apnea
Item
patients who require continuous oxygen supply or mechanical ventilation for treatment of obstructive sleep apnea
boolean
C0919655 (UMLS CUI [1,1])
C0520679 (UMLS CUI [1,2])
C0199470 (UMLS CUI [2,1])
C0520679 (UMLS CUI [2,2])
Medical condition Serious compromises Patient safety | Medical condition compromises Integrity Clinical Trial
Item
patients who have serious medical condition which can compromise the safety of the patients and the safety and integrity of the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1947912 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Drug use issue | Alcoholic Intoxication, Chronic
Item
patients who have unresolved drug issue, alcoholism
boolean
C4049580 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Protocol Compliance Unable
Item
patients who lack ability to understand and follow the instruction the researcher
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Unable
Item
patient who cannot follow up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients who are registered in other trial
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
patients who are pregnant, nursing or planning to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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