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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16,808
- 试验地点
- 8
- 主要终点
- Prevalence of atherosclerosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of atherosclerosis
时间窗: Immediately after the examination.
Prevalence of atherosclerosis using imaging.
Prevalence of silent atherosclerosis (plaque in at least one vascular territory)
时间窗: 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.
次要结局
- Presence of plaque in each vascular territory(At the baseline imaging visit (cross-sectional).)
- Plaque volume in each vascular territory(At the baseline imaging visit (cross-sectional).)
- Global peripheral plaque volume(At the baseline imaging visit (cross-sectional).)
- Coronary plaque volume(At the baseline imaging visit (cross-sectional).)
- Coronary artery calcium score (CACS)(At the baseline imaging visit (cross-sectional).)
研究者
Henning Bundgaard
Professor of Cardiology, consultant, MD, DMSc
Rigshospitalet, Denmark