DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life

NCT ID: NCT06692127

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 16000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2032-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Centro Nacional de Investigaciones Cardiovasculares Carlos III

UNKNOWN

Sponsor Role: collaborator

Gødstrup Hospital

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Henning Bundgaard

Professor of Cardiology, consultant, MD, DMSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Righospitalet - Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Herlev Hospital

Herlev, , Denmark

Site Status: NOT_YET_RECRUITING

Regionshospitalet Gødstrup

Herning, , Denmark

Site Status: RECRUITING

Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Denmark; Spain

Central Contacts

Henning Bundgaard, Professor

Role: CONTACT

henning.bundgaard@regionh.dk

+4535450512

Anna Ringgaard, PhD

Role: CONTACT

anna.kirstine.ringgaard@regionh.dk

+4535458361

Facility Contacts

Klaus Kofoed, Professor

Role: primary

klaus.Kofoed@regionh.dk

+35458569

Martin Lundsgaard Hansen, Chief physician

Role: primary

martin.lundsgaard.hansen@regionh.dk

+4535456109

Kasper Iversen, Professor

Role: primary

Kasper.Karmark.Iversen@regionh.dk

+4528712753

Morten Bøttcher, Professor

Role: primary

morboett@rm.dk

+4578430000

Borja Ibanez, MD, PhD, FESC

Role: primary

bibanez@cnic.es

(+34) 914531200

Other Identifiers

H-24047468

Identifier Type: -

Identifier Source: org_study_id