Detecting silent atherosclerosis in adults
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life and Development of a Risk Calculator to Predict Its Presence. Phase One of the REACT (Cure of Atherosclerosis) Project
This study is trying to find out how common hidden atherosclerosis is in adults of European descent by using ultrasound and CT scans to look at their blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 5 sites (Copenhagen and 4 other locations) |
| Trial ID | NCT06692127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the prevalence of asymptomatic atherosclerosis in adults of European ancestry using vascular ultrasound to assess peripheral arteries, including carotid and femoral territories. It will also explore the relationship between atherosclerosis in peripheral and coronary arteries through computed tomography angiography. By identifying risk factors for subclinical atherosclerosis, the study hopes to enhance the precision of detecting risks for atherosclerotic cardiovascular disease. The findings may inform future research and improve early detection strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 years who have not been diagnosed with atherosclerotic cardiovascular disease.
Not a fit: Patients with severe renal disease, contrast allergies, or pregnancy may not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for atherosclerotic cardiovascular disease.
How similar studies have performed: Other studies have shown success in identifying asymptomatic atherosclerosis, but this specific approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study will include adults ≥18 to ≤70 years of age (1:1 sex ratio in each 10 years age strata). * Have not been diagnosed with ASCVD prior to inclusion into the study (participants with other cardiovascular diseases or predisposing factors are not excluded). * The participants will be recruited from sites in Denmark (n \~ 8,000) (and Spain (n \~ 8,000)). * Participants need to be capable and be able to read and understand Danish, English, Spanish or Arabic. Exclusion Criteria: * The participants will be excluded from the CTA with contrast if they have severe renal disease (eGFR \<30 ml), contrast allergies, pregnancy or other conditions excluding the performance of a CT-scan.
Where this trial is running
Copenhagen and 4 other locations
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Righospitalet - Glostrup Hospital — Glostrup Municipality, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Not_yet_recruiting)
- Regionshospitalet Gødstrup — Herning, Denmark (Recruiting)
- Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Henning Bundgaard, Professor
- Email: henning.bundgaard@regionh.dk
- Phone: +4535450512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.