ID

21098

Description

Rheos Feasibility Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01077180

Link

https://clinicaltrials.gov/show/NCT01077180

Keywords

Versions (1)
  1. 4/10/17 4/10/17 -
Uploaded on

April 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01077180

English

Eligibility Hypertension NCT01077180

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. be at least 21 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. have been assessed to have bilateral carotid bifurcations located at or below c3-c4.
Description

Carotid bifurcation Bilateral C3 C4

Data type

boolean

Alias
UMLS CUI [1,1]
C0447037
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0223116
UMLS CUI [1,4]
C0223131
3. have an office cuff systolic blood pressure greater than or equal to 160 mmhg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmhg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
Description

Systolic Pressure Cuff | Blood pressure ambulatory Systolic 24 Hours | Antihypertensive Agents Quantity | Diuretic Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0441107
UMLS CUI [2,1]
C0855316
UMLS CUI [2,2]
C0039155
UMLS CUI [2,3]
C1442770
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C1265611
4. must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
Description

Compliance behavior | Intake Pharmaceutical Preparations Dosage Full

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0443225
5. have signed a cvrx approved informed consent for participation in this study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have been diagnosed with:
Description

Diagnosed

Data type

boolean

Alias
UMLS CUI [1]
C0011900
baroreflex failure
Description

Baroreflex failure

Data type

boolean

Alias
UMLS CUI [1]
C1959798
cardiac bradyarrhythmias
Description

Bradyarrhythmia cardiac

Data type

boolean

Alias
UMLS CUI [1,1]
C0079035
UMLS CUI [1,2]
C0018787
chronic atrial fibrillation
Description

Chronic atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0694539
2. had a heart transplant
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
3. have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
Description

Carotid Atherosclerosis | Diameter Linear Percentage Reduction | Ultrasonics | Angiography

Data type

boolean

Alias
UMLS CUI [1]
C0577631
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0392756
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0002978
4. have grade c ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
Description

Ulcerative lesions Grade Carotid Artery Ultrasonics | Ulcerative lesions Grade Carotid Artery Angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0041582
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0007272
UMLS CUI [1,4]
C1456803
UMLS CUI [2,1]
C0041582
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C0007272
UMLS CUI [2,4]
C0002978
5. have prior surgery or radiation in either carotid sinus region.
Description

Operative Surgical Procedure Carotid sinus Region Either | Therapeutic radiology procedure Carotid sinus Region Either

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0007281
UMLS CUI [1,3]
C0205147
UMLS CUI [1,4]
C3844638
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0007281
UMLS CUI [2,3]
C0205147
UMLS CUI [2,4]
C3844638
6. currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
Description

Implanted Medical Device Electrical | Cardiac pacing | Electric Countershock | Neurostimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C2828363
UMLS CUI [1,2]
C0442828
UMLS CUI [2]
C0199640
UMLS CUI [3]
C0013778
UMLS CUI [4]
C0521307
7. are pregnant or contemplating pregnancy during the 13-month follow-up period.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
8. currently undergoing dialysis.
Description

Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0011946
9. have hypertension secondary to a treatable cause.
Description

Hypertensive disease Cause Secondary to

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0175668
10. have clinically significant cardiac valvular disease.
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
11. are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
Description

Protocol Compliance Unwilling | Follow-up Requirement Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0558080
12. are unlikely to survive the protocol follow-up period.
Description

Follow-up Survival Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0038952
UMLS CUI [1,3]
C0750558
13. are enrolled in another concurrent clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Hypertension NCT01077180

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. be at least 21 years of age.
boolean
C0001779 (UMLS CUI [1])
Carotid bifurcation Bilateral C3 C4
Item
2. have been assessed to have bilateral carotid bifurcations located at or below c3-c4.
boolean
C0447037 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0223116 (UMLS CUI [1,3])
C0223131 (UMLS CUI [1,4])
Systolic Pressure Cuff | Blood pressure ambulatory Systolic 24 Hours | Antihypertensive Agents Quantity | Diuretic Quantity
Item
3. have an office cuff systolic blood pressure greater than or equal to 160 mmhg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmhg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
boolean
C0871470 (UMLS CUI [1,1])
C0441107 (UMLS CUI [1,2])
C0855316 (UMLS CUI [2,1])
C0039155 (UMLS CUI [2,2])
C1442770 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Compliance behavior | Intake Pharmaceutical Preparations Dosage Full
Item
4. must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
boolean
C1321605 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0443225 (UMLS CUI [2,4])
Informed Consent
Item
5. have signed a cvrx approved informed consent for participation in this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diagnosed
Item
1. have been diagnosed with:
boolean
C0011900 (UMLS CUI [1])
Baroreflex failure
Item
baroreflex failure
boolean
C1959798 (UMLS CUI [1])
Bradyarrhythmia cardiac
Item
cardiac bradyarrhythmias
boolean
C0079035 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Chronic atrial fibrillation
Item
chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Heart Transplantation
Item
2. had a heart transplant
boolean
C0018823 (UMLS CUI [1])
Carotid Atherosclerosis | Diameter Linear Percentage Reduction | Ultrasonics | Angiography
Item
3. have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
boolean
C0577631 (UMLS CUI [1])
C1301886 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C1456803 (UMLS CUI [3])
C0002978 (UMLS CUI [4])
Ulcerative lesions Grade Carotid Artery Ultrasonics | Ulcerative lesions Grade Carotid Artery Angiography
Item
4. have grade c ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
boolean
C0041582 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0007272 (UMLS CUI [1,3])
C1456803 (UMLS CUI [1,4])
C0041582 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0007272 (UMLS CUI [2,3])
C0002978 (UMLS CUI [2,4])
Operative Surgical Procedure Carotid sinus Region Either | Therapeutic radiology procedure Carotid sinus Region Either
Item
5. have prior surgery or radiation in either carotid sinus region.
boolean
C0543467 (UMLS CUI [1,1])
C0007281 (UMLS CUI [1,2])
C0205147 (UMLS CUI [1,3])
C3844638 (UMLS CUI [1,4])
C1522449 (UMLS CUI [2,1])
C0007281 (UMLS CUI [2,2])
C0205147 (UMLS CUI [2,3])
C3844638 (UMLS CUI [2,4])
Implanted Medical Device Electrical | Cardiac pacing | Electric Countershock | Neurostimulation
Item
6. currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
boolean
C2828363 (UMLS CUI [1,1])
C0442828 (UMLS CUI [1,2])
C0199640 (UMLS CUI [2])
C0013778 (UMLS CUI [3])
C0521307 (UMLS CUI [4])
Pregnancy | Pregnancy, Planned
Item
7. are pregnant or contemplating pregnancy during the 13-month follow-up period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Dialysis
Item
8. currently undergoing dialysis.
boolean
C0011946 (UMLS CUI [1])
Hypertensive disease Cause Secondary to
Item
9. have hypertension secondary to a treatable cause.
boolean
C0020538 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
Heart valve disease
Item
10. have clinically significant cardiac valvular disease.
boolean
C0018824 (UMLS CUI [1])
Protocol Compliance Unwilling | Follow-up Requirement Unwilling
Item
11. are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Follow-up Survival Unlikely
Item
12. are unlikely to survive the protocol follow-up period.
boolean
C3274571 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Study Subject Participation Status
Item
13. are enrolled in another concurrent clinical trial.
boolean
C2348568 (UMLS CUI [1])
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