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NCT Number: NCT06692127

DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

REACT (DETECT, Phase I) is a multicentre Danish-Spanish prospective cohort study. Adults 18 to 70 years of age without known atherosclerotic cardiovascular disease (ASCVD) were enrolled in five prespecified age strata (18-29, 30-39, 40-49, 50-59, 60-70 years) with an approximately equal number of women and men in each stratum. Enrollment was designed a priori to include approximately 2,000 participants in each of the 18-29 and 60-70 year strata and approximately 4,000 in each of the 30-39, 40-49 and 50-59 year strata, across four sites in Denmark and four sites in Spain.

All participants underwent multimodal imaging for silent atherosclerosis: three-dimensional vascular ultrasound of the carotid and femoral arteries, coronary computed tomography angiography (CCTA), and non-contrast computed tomography for coronary artery calcium scoring (CACS), together with extensive clinical, lifestyle, psychological and biological (blood, urine, DNA) phenotyping. Participants were enrolled from November 2024 through June 2026.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of silent atherosclerosis (plaque in at least one vascular territory)

    Time frame: At the baseline imaging visit (cross-sectional).

    Presence of silent (asymptomatic) atherosclerosis, defined as atherosclerotic plaque in at least one examined vascular territory (carotid, femoral, or coronary arteries), assessed by three-dimensional vascular ultrasound (carotid and femoral) and coronary computed tomography angiography.

Secondary outcomes

  1. Presence of plaque in each vascular territory

    Time frame: At the baseline imaging visit (cross-sectional).

    Presence of atherosclerotic plaque in the carotid, femoral, and coronary territories, reported separately.

  2. Plaque volume in each vascular territory

    Time frame: At the baseline imaging visit (cross-sectional).

    Atherosclerotic plaque volume (mm3) in the carotid, femoral, and coronary territories, reported separately.

  3. Global peripheral plaque volume

    Time frame: At the baseline imaging visit (cross-sectional).

    Sum of atherosclerotic plaque volume (mm3) across the carotid and femoral (peripheral) territories.

  4. Coronary plaque volume

    Time frame: At the baseline imaging visit (cross-sectional).

    Total coronary atherosclerotic plaque volume (mm3) assessed by coronary computed tomography angiography.

  5. Coronary artery calcium score (CACS)

    Time frame: At the baseline imaging visit (cross-sectional).

    Coronary artery calcium score (Agatston units) assessed by non-contrast computed tomography.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
  • Gødstrup Hospital
  • Herlev and Gentofte Hospital
  • The Novo Nordisk Foundation

Registry information

Official study title

DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life and Development of a Risk Calculator to Predict Its Presence. Phase I of the REACT (Early Cure of Atherosclerosis) Project

Acronym: DETECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
Nov 18, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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