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Carotid Ultrasound Study

NCT ID: NCT02001350

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

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To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.

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Detailed Description

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Conditions

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Resistant Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Resistant hypertension

Ultrasonography

Intervention Type OTHER

Interventions

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Ultrasonography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old
* Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.

Exclusion Criteria

* Previous stroke
* Carotid endarterectomy or carotid stent procedure
* \>50% stenosis anywhere in carotid arteries
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cibiem, Inc.

INDUSTRY

Sponsor Role collaborator

Noblewell

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul A. Sobotka, MD

Role: STUDY_DIRECTOR

Cibiem, Inc.

Locations

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Department of Hypertension and Diabetology, Medical University of Gdansk

Gdansk, , Poland

Site Status

Countries

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Poland

Other Identifiers

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CIB-USG.GDA.PL

Identifier Type: -

Identifier Source: org_study_id

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