ID

15293

Descripción

Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN; ODM derived from: https://clinicaltrials.gov/show/NCT02364310

Link

https://clinicaltrials.gov/show/NCT02364310

Palabras clave

Versiones (1)
  1. 25/5/16 25/5/16 -
Subido en

25 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT02364310

Inglés

Eligibility Hypertension NCT02364310

1 formularios  
Criteria
Descripción

Criteria

18-75 y old men or women
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
resistant hypertension on 4 medications incl. thiazide or thiazide-like diuretics at appropriate doses + spironolactone (unless spironolactone intolerance)
Descripción

HYPERTENSION RESISTANT | Pharmaceutical Preparations | Thiazide | Thiazide-like Diuretic | Spironolactone | Intolerance to Spironolactone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0745130
UMLS CUI [2]
C0013227
UMLS CUI [3]
C0541746
UMLS CUI [4]
C2266922
UMLS CUI [5]
C0037982
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0037982
essential hypertension documented (bilan < 2 years old)
Descripción

Essential Hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085580
egfr ≥ 30 ml/min/1,73 m2
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
no carotid condition associated with a contra-indication for barostim neotm use
Descripción

Carotid Arteries Condition | Medical contraindication Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007272
UMLS CUI [1,2]
C0348080
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0087111
main exclusion criteria:
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
patients with documented secondary hypertension, besides obstructive sleep apnea
Descripción

Secondary hypertension | Sleep Apnea, Obstructive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0520679
symptomatic orthostatic hypotension
Descripción

Hypotension orthostatic symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0740482
patient with prior syncope or myocardial infarction, unstable angina pectoris, or cerebrovascular within 3 months before inclusion
Descripción

Syncope Previous | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0039070
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0038454
patient with type 1 diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
patient with permanent atrial fibrillation
Descripción

Permanent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2586056
patient with brachial circumference of ≥ 46cm
Descripción

Mid upper arm circumference

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0562351
patient with bmi>45kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
pregnancy, breastfeeding or planning a pregnancy within 2 years
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
neotm implantation anatomic contra-indications
Descripción

Anatomic contraindication Implantation Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0220784
UMLS CUI [1,3]
C0021107
UMLS CUI [1,4]
C2346570
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Similar models

Eligibility Hypertension NCT02364310

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
18-75 y old men or women
boolean
C0001779 (UMLS CUI [1])
HYPERTENSION RESISTANT | Pharmaceutical Preparations | Thiazide | Thiazide-like Diuretic | Spironolactone | Intolerance to Spironolactone
Item
resistant hypertension on 4 medications incl. thiazide or thiazide-like diuretics at appropriate doses + spironolactone (unless spironolactone intolerance)
boolean
C0745130 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0541746 (UMLS CUI [3])
C2266922 (UMLS CUI [4])
C0037982 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0037982 (UMLS CUI [6,2])
Essential Hypertension
Item
essential hypertension documented (bilan < 2 years old)
boolean
C0085580 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr ≥ 30 ml/min/1,73 m2
boolean
C3811844 (UMLS CUI [1])
Carotid Arteries Condition | Medical contraindication Therapeutic procedure
Item
no carotid condition associated with a contra-indication for barostim neotm use
boolean
C0007272 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Exclusion Criteria
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Secondary hypertension | Sleep Apnea, Obstructive
Item
patients with documented secondary hypertension, besides obstructive sleep apnea
boolean
C0155616 (UMLS CUI [1])
C0520679 (UMLS CUI [2])
Hypotension orthostatic symptomatic
Item
symptomatic orthostatic hypotension
boolean
C0740482 (UMLS CUI [1])
Syncope Previous | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
patient with prior syncope or myocardial infarction, unstable angina pectoris, or cerebrovascular within 3 months before inclusion
boolean
C0039070 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
patient with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Permanent atrial fibrillation
Item
patient with permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
Mid upper arm circumference
Item
patient with brachial circumference of ≥ 46cm
boolean
C0562351 (UMLS CUI [1])
Body mass index
Item
patient with bmi>45kg/m2
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy, breastfeeding or planning a pregnancy within 2 years
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Anatomic contraindication Implantation Investigational Medical Device
Item
neotm implantation anatomic contra-indications
boolean
C1301624 (UMLS CUI [1,1])
C0220784 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
C2346570 (UMLS CUI [1,4])
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