NCT02001350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

November 22, 2013

Last Update Submit

October 14, 2016

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

  • Specific location of carotid plaque at the bifurcation

    Baseline

Study Arms (1)

Resistant hypertension

Other: Ultrasonography

Interventions

UltrasonographyOTHER
Resistant hypertension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30 patients with longstanding or resistant hypertension

You may qualify if:

  • years old
  • Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.

You may not qualify if:

  • Previous stroke
  • Carotid endarterectomy or carotid stent procedure
  • \>50% stenosis anywhere in carotid arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hypertension and Diabetology, Medical University of Gdansk

Gdansk, 80-952, Poland

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Paul A. Sobotka, MD

    Cibiem, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 4, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

PL(1)