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Carotid Ultrasound Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02001350
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Cibiem, Inc.
Information provided by (Responsible Party):
Noblewell

Brief Summary:
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.

Condition or disease Intervention/treatment
Resistant Hypertension Other: Ultrasonography

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Carotid Ultrasound Study
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Resistant hypertension Other: Ultrasonography



Primary Outcome Measures :
  1. Specific location of carotid plaque at the bifurcation [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
30 patients with longstanding or resistant hypertension
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001350


Locations
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Poland
Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, Poland, 80-952
Sponsors and Collaborators
Noblewell
Cibiem, Inc.
Investigators
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Study Director: Paul A. Sobotka, MD Cibiem, Inc.
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Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT02001350    
Other Study ID Numbers: CIB-USG.GDA.PL
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases