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

NCT06933745 | Completed DMC

• 1 other identifier: Ahus, BDA
• Study Type: observational
• Target: 21,029
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cardiovascular Diseases; Fatty Liver; Atherosclerosis of Femoral Artery; Carotid Artery Plaque; Stroke; Ischemic Cardiovascular Disease; Atheroscleroses

Keywords

Ultrasound; Carotid arteries; Femoral arteries; Cardiovascular Disseases; Plaque burden; Subclinical atherosclerosis; NORRISK2; Ischemic stroke; Ischemic heart disease; Atherosclerotic cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From enrollment to an average of 10 years.

Study Arms (2)

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

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• If they do not consent to participate

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator

Study Sites (1)

Austad Diagnostikk

Oslo, East, 0366, Norway

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Fatty Liver; Carotid Stenosis; Stroke; Atherosclerosis; Ischemic Stroke; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Arteriosclerosis; Heart Diseases

Study Officials

• Jonn-Terje Geitung, MD, PhD, MHA

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Serena N.H. Tonstad, MD, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 18, 2025
• Study Start: April 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)