ID

36140

Description

SPYRAL HTN-ON MED Study; ODM derived from: https://clinicaltrials.gov/show/NCT02439775

Link

https://clinicaltrials.gov/show/NCT02439775

Keywords

  1. 4/17/19 4/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypertension NCT02439775

Eligibility Hypertension NCT02439775

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individual has office systolic blood pressure (sbp) ≥ 150 mmhg and <180 mmhg and a diastolic blood pressure (dbp) ≥ 90 mmhg after being off medications.
Description

Office Systolic Pressure | Office Diastolic blood pressure | Status post Pharmaceutical Preparations Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C0871470
UMLS CUI [2,1]
C0442603
UMLS CUI [2,2]
C0428883
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1444662
individual has 24-hour ambulatory blood pressure monitoring (abpm) average sbp ≥ 140 mmhg and < 170 mmhg.
Description

24-hour ambulatory blood pressure monitoring | Average Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C2022220
UMLS CUI [2,1]
C1510992
UMLS CUI [2,2]
C0871470
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individual lacks appropriate renal artery anatomy.
Description

Renal artery Anatomy Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1548788
individual has estimated glomerular filtration rate (egfr) of <45.
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
individual has one or more episodes of orthostatic hypotension.
Description

Episode of Orthostatic Hypotension Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0020651
UMLS CUI [1,3]
C1265611
individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Description

Oxygen supplementation chronic Sleep Apnea | Mechanical ventilation chronic Sleep Apnea | Exception Support Respiratory Nocturnal

Data type

boolean

Alias
UMLS CUI [1,1]
C0919655
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0037315
UMLS CUI [2,1]
C0199470
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0037315
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1521721
UMLS CUI [3,3]
C0521346
UMLS CUI [3,4]
C0240526
individual has primary pulmonary hypertension.
Description

Primary pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
individual is pregnant, nursing or planning to become pregnant.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory drugs (nsaids). aspirin therapy is allowed.
Description

Non-Steroidal Anti-Inflammatory Agents chronic | Aspirin therapy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C4303556
UMLS CUI [2,2]
C0683607
individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
Description

Myocardial Infarction | Angina, Unstable | Syncope | Cerebrovascular accident | Atherosclerosis Widespread | Intravascular thrombosis | Plaque Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0039070
UMLS CUI [4]
C0038454
UMLS CUI [5,1]
C0004153
UMLS CUI [5,2]
C0205391
UMLS CUI [6]
C0442860
UMLS CUI [7,1]
C2936350
UMLS CUI [7,2]
C0443343
individual works night shifts.
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008

Similar models

Eligibility Hypertension NCT02439775

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Office Systolic Pressure | Office Diastolic blood pressure | Status post Pharmaceutical Preparations Discontinued
Item
individual has office systolic blood pressure (sbp) ≥ 150 mmhg and <180 mmhg and a diastolic blood pressure (dbp) ≥ 90 mmhg after being off medications.
boolean
C0442603 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0442603 (UMLS CUI [2,1])
C0428883 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
24-hour ambulatory blood pressure monitoring | Average Systolic Pressure
Item
individual has 24-hour ambulatory blood pressure monitoring (abpm) average sbp ≥ 140 mmhg and < 170 mmhg.
boolean
C2022220 (UMLS CUI [1])
C1510992 (UMLS CUI [2,1])
C0871470 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Renal artery Anatomy Inappropriate
Item
individual lacks appropriate renal artery anatomy.
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
individual has estimated glomerular filtration rate (egfr) of <45.
boolean
C3811844 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Episode of Orthostatic Hypotension Quantity
Item
individual has one or more episodes of orthostatic hypotension.
boolean
C0332189 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Oxygen supplementation chronic Sleep Apnea | Mechanical ventilation chronic Sleep Apnea | Exception Support Respiratory Nocturnal
Item
individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
boolean
C0919655 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0037315 (UMLS CUI [1,3])
C0199470 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0037315 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1521721 (UMLS CUI [3,2])
C0521346 (UMLS CUI [3,3])
C0240526 (UMLS CUI [3,4])
Primary pulmonary hypertension
Item
individual has primary pulmonary hypertension.
boolean
C0152171 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
individual is pregnant, nursing or planning to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Non-Steroidal Anti-Inflammatory Agents chronic | Aspirin therapy allowed
Item
individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory drugs (nsaids). aspirin therapy is allowed.
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C4303556 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Myocardial Infarction | Angina, Unstable | Syncope | Cerebrovascular accident | Atherosclerosis Widespread | Intravascular thrombosis | Plaque Unstable
Item
individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0039070 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0004153 (UMLS CUI [5,1])
C0205391 (UMLS CUI [5,2])
C0442860 (UMLS CUI [6])
C2936350 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
Night shift worker
Item
individual works night shifts.
boolean
C0555008 (UMLS CUI [1])

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