ID

40354

Beschrijving

Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01887067

Link

https://clinicaltrials.gov/show/NCT01887067

Trefwoorden

Versies (1)
  1. 11-04-20 11-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 april 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypertension, Resistant NCT01887067

Engels

Eligibility Hypertension, Resistant NCT01887067

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ranges from 18 to 70 years inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertension
Beschrijving

Essential Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
office systolic bp (sbp) ≥ 150 mmhg or diastolic bp (dbp) ≥ 90mmhg
Beschrijving

Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
Beschrijving

Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretics | Intolerance to Pharmaceutical Preparations multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [3]
C0012798
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0439064
type 2 diabetes mellitus on oral hypoglycaemic agent (oha)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0359086
2 functional kidneys; egfr ≥ 45 ml/min/1.73m² (mdrd formula)
Beschrijving

Both kidneys Functional | GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1,1]
C0227665
UMLS CUI [1,2]
C0205245
UMLS CUI [2]
C2170215
suitable renal anatomy compatible with the endovascular denervation procedure
Beschrijving

Kidney Anatomy suitable Renal artery denervation | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C3544270
UMLS CUI [2]
C3846158
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
individual has renal artery anatomy that is ineligible for treatment including:
Beschrijving

Renal artery Anatomy Ineligible Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
patients with secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
Beschrijving

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
patient with type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
patient on insulin due to oral drug failure
Beschrijving

Insulin | Etiology Oral medication Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0175795
UMLS CUI [2,3]
C0162643
renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
Beschrijving

Renal vascular disorder | Renal Artery Stenosis Severe | Renal stenting | Angioplasty renal artery | Renal arteries Dual

Datatype

boolean

Alias
UMLS CUI [1]
C0268790
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1262325
UMLS CUI [4]
C1282893
UMLS CUI [5,1]
C0035065
UMLS CUI [5,2]
C0205173
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patient with any implantable device incompatible with radiofrequency energy delivery
Beschrijving

Implant Inconsistent Radiofrequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0579006
hemodynamically significant valvular heart disease for which reduction of bp would be considered hazardous
Beschrijving

Heart valve disease Hemodynamic Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
Beschrijving

Medical condition Serious | Life Expectancy Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
Terug naar het begin van de pagina

Similar models

Eligibility Hypertension, Resistant NCT01887067

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ranges from 18 to 70 years inclusive
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
essential hypertension
boolean
C0085580 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
office systolic bp (sbp) ≥ 150 mmhg or diastolic bp (dbp) ≥ 90mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive Agents Quantity | Antihypertensive Agents Class Different | Diuretics | Intolerance to Pharmaceutical Preparations multiple
Item
3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0439064 (UMLS CUI [4,3])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic
Item
type 2 diabetes mellitus on oral hypoglycaemic agent (oha)
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Both kidneys Functional | GFR estimation by MDRD
Item
2 functional kidneys; egfr ≥ 45 ml/min/1.73m² (mdrd formula)
boolean
C0227665 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Kidney Anatomy suitable Renal artery denervation | Other Coding
Item
suitable renal anatomy compatible with the endovascular denervation procedure
boolean
C0022646 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C3544270 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Renal artery Anatomy Ineligible Therapy
Item
individual has renal artery anatomy that is ineligible for treatment including:
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Secondary hypertension
Item
patients with secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
patient with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin | Etiology Oral medication Failure
Item
patient on insulin due to oral drug failure
boolean
C0021641 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
C0162643 (UMLS CUI [2,3])
Renal vascular disorder | Renal Artery Stenosis Severe | Renal stenting | Angioplasty renal artery | Renal arteries Dual
Item
renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
boolean
C0268790 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1262325 (UMLS CUI [3])
C1282893 (UMLS CUI [4])
C0035065 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Implant Inconsistent Radiofrequency
Item
patient with any implantable device incompatible with radiofrequency energy delivery
boolean
C0021102 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0579006 (UMLS CUI [1,3])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease for which reduction of bp would be considered hazardous
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Medical condition Serious | Life Expectancy Limited
Item
any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial