DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life (DETECT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atheroslerosis

• Study Type: Observational
• Enrollment (Estimated): 16000

Contacts and Locations

• Study Contact: Name: Henning Bundgaard, Professor; Phone Number: +4535450512; Email: henning.bundgaard@regionh.dk
• Study Contact Backup: Name: Anna Ringgaard, PhD; Phone Number: +4535458361; Email: anna.kirstine.ringgaard@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Klaus Kofoed, Professor; Phone Number: +35458569; Email: klaus.Kofoed@regionh.dk
  • Glostrup, Denmark
    • Recruiting
    • Righospitalet - Glostrup Hospital
    • Contact: Martin Lundsgaard Hansen, Chief physician; Phone Number: +4535456109; Email: martin.lundsgaard.hansen@regionh.dk
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Herlev Hospital
    • Contact: Kasper Iversen, Professor; Phone Number: +4528712753; Email: Kasper.Karmark.Iversen@regionh.dk
  • Herning, Denmark, 7400
    • Recruiting
    • Regionshospitalet Gødstrup
    • Contact: Morten Bøttcher, Professor; Phone Number: +4578430000; Email: morboett@rm.dk
• Spain
  • Madrid, Spain, E-28029
    • Not yet recruiting
    • Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)
    • Contact: Borja Ibanez, MD, PhD, FESC; Phone Number: (+34) 914531200; Email: bibanez@cnic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

spansk eog danske baggrundsbefolkning

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of atherosclerosis	Prevalence of atherosclerosis using imaging.	Immediately after the examination.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: H-24047468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No