Ultrasound Assessment of Atherosclerotic Plaque Burden and Cardiovascular Risk: A 10-Year Prospective Study (P-SONAR)

April 17, 2025 updated by: Jonn Terje Geitung, University Hospital, Akershus

Ultrasound of Carotid and Femoral Plaque Burden and Non-alcoholic Fatty Liver Disease as Predictors of Cardiovascular Disease

The P-SONAR study is a large, observational, prospective cohort study. The overall aim of the study is to investigate whether plaque burden estimation by 2D ultrasound of the carotid and femoral arteries may enhance cardiovascular risk prediction beyond NORRISK-2

Study Overview

Status

Completed

Conditions

Detailed Description

Design: The P-SONAR Study is a prospective cohort study of all men and women aged 45-74 years attending a health check at one of 10 ultrasound clinics in Norway.

Time schedule: Study inclusion and baseline examinations took place in the period April 2022- March 20025.

Current status: Ultrasound follow-up examinations take place from January 2025 - December 2029.

Study Type

Observational

Enrollment (Actual)

21029

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • East
      • Oslo, East, Norway, 0366
        • Austad Diagnostikk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population comprises consecutive persons 45-74 years self-reffered for a health check in one of 10 ultrasound clinics in Norway.

Description

Inclusion Criteria: Persons attending a health check during the study period.

-

Exclusion Criteria:

  • If they do not consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants undergoing ultrasound and screening for conventional CV risk factors.
A sub-cohort consists of 5 500 participants who undergo both carotid and femoral ultrasound and fatty liver status assessment by ultrasound, in addition to assessement of traditional CV risk factors including history of smoking, total-cholesterol, LDL-cholesterol, HDL-cholesterol, Lp(a), blood glucose, systolic and diastolic blood pressure and waist circumference measurements.
Participants undergoing ultrasound examination
Total cohort consists of 22 000 participants who undergo both carotid and femoral ultrasound and fatty liver status assessment by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
May plaque burden predict incident cardiovascular disease.
Time Frame: From enrollment to an average of 10 years.
Find best cutoff value of wTPT plaque burden to predict incident CV disease, across different age groups and sex.
From enrollment to an average of 10 years.
Carotid and femoral plaque burden cardiovascular (CV) predictive ability beyond NORRISK-2
Time Frame: From enrollment to an average of 10 years
Additative ability of carotid and femoral plaque burden assessed by ultrasound to predict incident cardiovascular events, beyond conventional risk factors by NORRISK-2
From enrollment to an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Jonn-Terje Geitung, MD, PhD, MHA, University of Oslo
  • Study Director: Serena N.H. Tonstad, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahus, BDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because of the sensitive nature of the data in this study, participants were assured that raw data would remain confidential and would not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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