Atherosclerosis, Cardiovascular Diseases, Subclinical Atherosclerosis
Conditions
Keywords
REACT, DETECT, Silent atherosclerosis, Primary prevention, Vascular ultrasound, Coronary CT angiography
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
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.
Interventions
None listed
Sponsors
Rigshospitalet, Denmark
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Gødstrup Hospital
Herlev and Gentofte Hospital
The Novo Nordisk Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of silent atherosclerosis (plaque in at least one vascular territory) | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of plaque in each vascular territory | At the baseline imaging visit (cross-sectional). | Presence of atherosclerotic plaque in the carotid, femoral, and coronary territories, reported separately. |
| Plaque volume in each vascular territory | At the baseline imaging visit (cross-sectional). | Atherosclerotic plaque volume (mm3) in the carotid, femoral, and coronary territories, reported separately. |
| Global peripheral plaque volume | At the baseline imaging visit (cross-sectional). | Sum of atherosclerotic plaque volume (mm3) across the carotid and femoral (peripheral) territories. |
| Coronary plaque volume | At the baseline imaging visit (cross-sectional). | Total coronary atherosclerotic plaque volume (mm3) assessed by coronary computed tomography angiography. |
| Coronary artery calcium score (CACS) | At the baseline imaging visit (cross-sectional). | Coronary artery calcium score (Agatston units) assessed by non-contrast computed tomography. |
Countries
Denmark, Spain
Contacts
PRINCIPAL_INVESTIGATORHenning Bundgaard, MD, DMSc
Rigshospitalet, Denmark
PRINCIPAL_INVESTIGATORBorja Ibanez, MD, PhD
CNIC
Outcome results
None listed