ID

40123

Beschrijving

Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound; ODM derived from: https://clinicaltrials.gov/show/NCT01704170

Link

https://clinicaltrials.gov/show/NCT01704170

Trefwoorden

Versies (1)
  1. 12-03-20 12-03-20 -
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See clinicaltrials.gov

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12 maart 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT01704170

Engels

Eligibility Hypertension NCT01704170

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subject has systolic blood pressure of 160 mmhg in average or greater.
Beschrijving

Average systolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1282151
subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
Beschrijving

Refractory hypertension Stable | Antihypertensive Agents Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0860493
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
subject has two functioning kidneys, defined as egfr ≥ 45 ml/min.
Beschrijving

Both kidneys functioning | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0227665
UMLS CUI [1,2]
C0542341
UMLS CUI [2]
C3811844
subject has at least one renal artery on each side which is greater than 4mm.
Beschrijving

Renal artery Diameter Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has hydronephrosis as seen on mra or ultrasound.
Beschrijving

Hydronephrosis MRA | Hydronephrosis Ultrasonography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0243032
UMLS CUI [2,1]
C0020295
UMLS CUI [2,2]
C0041618
subject has renal stenosis greater than 50% based on baseline mra.
Beschrijving

Renal Artery Stenosis Percentage MRA

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0243032
subject has a renal stent or other implant in the region.
Beschrijving

STENT, RENAL | Implant Region of kidney

Datatype

boolean

Alias
UMLS CUI [1]
C1262325
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1276227
subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
Beschrijving

Kidney Calculi Symptomatic | Kidney Calculi Size | Kidney Calculi Interfere with Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0022650
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0022650
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0087111
subject has a history of abdominal surgery within the past six months.
Beschrijving

Operation on abdominal region

Datatype

boolean

Alias
UMLS CUI [1]
C0198482
subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
Beschrijving

Heterogeneity Kidney Interferes with Treatment | Renal cyst Large | Kidney Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019409
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3887499
UMLS CUI [2,2]
C0549177
UMLS CUI [3]
C0022665
subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
Beschrijving

Pyelonephritis | History of Pyelonephritis Interferes with Treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0034186
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0034186
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0087111
subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
Beschrijving

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
subject has hemodynamically significant valvular heart disease.
Beschrijving

Heart valve disease Hemodynamics Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri.
Beschrijving

Implantable defibrillator | Pacemaker | Neurostimulator | Medical Device Inconsistent MRI

Datatype

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0810633
UMLS CUI [3]
C0582124
UMLS CUI [4,1]
C0025080
UMLS CUI [4,2]
C0442809
UMLS CUI [4,3]
C0024485
subject has a body weight > 150 kilograms.
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
subject has a target treatment depth > 14 cm.
Beschrijving

Target Treatment Depth

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205125
subject is pregnant, nursing or intends to become pregnant during the trial period.
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
subject is currently enrolled in other potentially confounding research.
Beschrijving

Study Subject Participation Status | Research study Interferes with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0681814
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Beschrijving

Patient condition Excludes Participation Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0008976
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Similar models

Eligibility Hypertension NCT01704170

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Average systolic blood pressure
Item
subject has systolic blood pressure of 160 mmhg in average or greater.
boolean
C1282151 (UMLS CUI [1])
Refractory hypertension Stable | Antihypertensive Agents Quantity
Item
subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
boolean
C0860493 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Both kidneys functioning | Estimated Glomerular Filtration Rate
Item
subject has two functioning kidneys, defined as egfr ≥ 45 ml/min.
boolean
C0227665 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Renal artery Diameter Quantity
Item
subject has at least one renal artery on each side which is greater than 4mm.
boolean
C0035065 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hydronephrosis MRA | Hydronephrosis Ultrasonography
Item
subject has hydronephrosis as seen on mra or ultrasound.
boolean
C0020295 (UMLS CUI [1,1])
C0243032 (UMLS CUI [1,2])
C0020295 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Renal Artery Stenosis Percentage MRA
Item
subject has renal stenosis greater than 50% based on baseline mra.
boolean
C0035067 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0243032 (UMLS CUI [1,3])
STENT, RENAL | Implant Region of kidney
Item
subject has a renal stent or other implant in the region.
boolean
C1262325 (UMLS CUI [1])
C0021102 (UMLS CUI [2,1])
C1276227 (UMLS CUI [2,2])
Kidney Calculi Symptomatic | Kidney Calculi Size | Kidney Calculi Interfere with Treatment
Item
subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
boolean
C0022650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0022650 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0022650 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Operation on abdominal region
Item
subject has a history of abdominal surgery within the past six months.
boolean
C0198482 (UMLS CUI [1])
Heterogeneity Kidney Interferes with Treatment | Renal cyst Large | Kidney Neoplasm
Item
subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
boolean
C0019409 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3887499 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0022665 (UMLS CUI [3])
Pyelonephritis | History of Pyelonephritis Interferes with Treatment
Item
subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
boolean
C0034186 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0034186 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Heart valve disease Hemodynamics Significance
Item
subject has hemodynamically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Implantable defibrillator | Pacemaker | Neurostimulator | Medical Device Inconsistent MRI
Item
subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri.
boolean
C0162589 (UMLS CUI [1])
C0810633 (UMLS CUI [2])
C0582124 (UMLS CUI [3])
C0025080 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Body Weight
Item
subject has a body weight > 150 kilograms.
boolean
C0005910 (UMLS CUI [1])
Target Treatment Depth
Item
subject has a target treatment depth > 14 cm.
boolean
C1521840 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subject is pregnant, nursing or intends to become pregnant during the trial period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Research study Interferes with Clinical Trial
Item
subject is currently enrolled in other potentially confounding research.
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Patient condition Excludes Participation Clinical Trial
Item
subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
boolean
C0683521 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
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