DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life

NCT06692127 | Recruiting DMC

• 1 other identifier: H-24047468
• Study Type: observational
• Target: 16,000
• Locations: 2 countries
• Sites: 5

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.

Conditions

Atheroslerosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of atherosclerosis

  Prevalence of atherosclerosis using imaging.

  Immediately after the examination.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

spansk eog danske baggrundsbefolkning

You may qualify if:

• The study will include adults ≥18 to ≤70 years of age (1:1 sex ratio in each 10 years age strata).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator
• Centro Nacional de Investigaciones Cardiovasculares Carlos III: collaborator
• Gødstrup Hospital: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (5)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Righospitalet - Glostrup Hospital

Glostrup Municipality, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Regionshospitalet Gødstrup

Herning, 7400, Denmark

RECRUITING

Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)

Madrid, E-28029, Spain

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine

Central Study Contacts

Henning Bundgaard, Professor

CONTACT

+4535450512; henning.bundgaard@regionh.dk

Anna Ringgaard, PhD

CONTACT

+4535458361; anna.kirstine.ringgaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, consultant, MD, DMSc

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2032
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4); ES (1)