Cardiovascular DiseasesP-SONARNCT06933745
Ultrasound Assessment of Atherosclerotic Plaque Burden and Cardiovascular Risk: A 10-Year Prospective Study
An observational study of Cardiovascular Diseases and Fatty Liver, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Fatty Liver, Atherosclerosis of Femoral Artery
- How many people
- 21,029 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2022to 1 Mar 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- If they do not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cardiovascular Diseases, Fatty Liver, Atherosclerosis of Femoral Artery, Carotid Artery Plaque, Stroke, Ischemic Cardiovascular Disease
- Keywords
- Ultrasound, Carotid arteries, Femoral arteries, Cardiovascular Disseases, Plaque burden, Subclinical atherosclerosis, NORRISK2, Ischemic stroke, Ischemic heart disease, Atherosclerotic cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Fatty Liver, Carotid Stenosis, Stroke, Atherosclerosis, Ischemic Stroke, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Carotid and femoral plaque burden cardiovascular (CV) predictive ability beyond NORRISK-2
Additative ability of carotid and femoral plaque burden assessed by ultrasound to predict incident cardiovascular events, beyond conventional risk factors by NORRISK-2
Measured: From enrollment to an average of 10 years
May plaque burden predict incident cardiovascular disease.
Find best cutoff value of wTPT plaque burden to predict incident CV disease, across different age groups and sex.
Measured: From enrollment to an average of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Apr 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21,029 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Jonn Terje Geitung, University of Oslo
- Investigators
- Jonn-Terje Geitung, MD, PhD, MHA, Principal investigator, University of OsloSerena N.H. Tonstad, MD, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933745
- Sponsor's protocol ID
- Ahus, BDA
- Acronym
- P-SONAR
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Austad G, Geitung JT, Thomas O, Tonstad S. Discriminating established cardiovascular disease using a novel multiterritory ultrasound plaque burden measure (wTPT): findings from the P-SONAR study. BMC Cardiovasc Disord. 2026 Apr 9;26(1):428. doi: 10.1186/s12872-026-05807-8.
PubMed 41952119
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound of Carotid and Femoral Plaque Burden and Non-alcoholic Fatty Liver Disease as Predictors of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06933745
- Acronym / sponsor ID
- P-SONAR / Ahus, BDA
- Conditions
- Cardiovascular Diseases, Fatty Liver, Atherosclerosis of Femoral Artery, Carotid Artery Plaque, Stroke, Ischemic Cardiovascular Disease
- Keywords
- Ultrasound, Carotid arteries, Femoral arteries, Cardiovascular Disseases, Plaque burden, Subclinical atherosclerosis, NORRISK2, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,029 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- If they do not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 41952119Austad G, Geitung JT, Thomas O, Tonstad S. Discriminating established cardiovascular disease using a novel multiterritory ultrasound plaque burden measure (wTPT): findings from the P-SONAR study. BMC Cardiovasc Disord. 2026 Apr 9;26(1):428. doi: 10.1186/s12872-026-05807-8.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonn-Terje Geitung, MD, PhD, MHA principal investigator
University of Oslo
Serena N.H. Tonstad, MD, PhD study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Fatty Liver, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid and femoral plaque burden cardiovascular (CV) predictive ability beyond NORRISK-2 (time frame: From enrollment to an average of 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.