Carotid Ultrasound Study

Resistant Hypertension Clinical Trial

Official title:

Carotid Ultrasound Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001350
• Other study ID #: CIB-USG.GDA.PL
• Status: Completed
• Phase: N/A
• First received: November 22, 2013
• Last updated: October 14, 2016
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Noblewell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Resistant Hypertension

Intervention

Other:
• Ultrasonography

Locations

Country	Name	City	State
Poland	Department of Hypertension and Diabetology, Medical University of Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Noblewell	Cibiem, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific location of carotid plaque at the bifurcation		Baseline	No