DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life

Recruiting

• Conditions: Atheroslerosis

• Registration Number: NCT06692127
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Atherosclerosis is preventable, yet it continues to significantly contribute to global morbidity and mortality. Atherosclerosis may occur early in life and may present in all vascular territories. The DETECT study's main aim is to determine the prevalence of asymptomatic atherosclerosis (silent) in an adult population of a wide age range of European ancestry through vascular ultrasound (VUS) of peripheral arteries (carotid and femoral territories), as well as establishing the relationship between atherosclerosis in peripheral arteries, coronary arteries, and other vascular territories assessed by computed tomography angiography (CTA).

The DETECT study also aims to identify risk factors for development of subclinical atherosclerosis that can hopefully improve the detection of the risk for development of atherosclerotic cardiovascular disease (ASCVD) with far higher precision than currently. In future research, the findings in this descriptive study may eventually be used as part of an age-adapted imaging-based screening for subclinical atherosclerosis.

The investigators hypothesize that a precision medicine-based approach to identify candidates likely to benefit from primary prevention against atherosclerosis, may improve medical decision making, by combining traditional risk factors, including lifestyle and psychological factors, phenotypic findings and findings on vascular imaging, and patterns of circulating biomarkers to identify risk of atherosclerosis especially in young individuals and at earlier disease stages (the ultimate population target of REACT project, phase II), maximizing the potential for prevention long before overt disease occurs. An essential aspect of this approach is to pinpoint the specific risk factors in each individual that primarily drive atherosclerosis throughout their life and could serve as therapeutic targets.

Thus, the overall purpose of this study is to establish the necessary knowledge, including extensive characterisation of atherosclerosis across life and thus add to the rational foundation for future development of a far more efficient and precise prophylaxis against ASCVD as compared with the presently applied methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of atherosclerosis	Immediately after the examination.	Prevalence of atherosclerosis using imaging.

Trial Locations

Locations (5)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Righospitalet - Glostrup Hospital; 🇩🇰 Glostrup, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Regionshospitalet Gødstrup; 🇩🇰 Herning, Denmark

Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC); 🇪🇸 Madrid, Spain