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Clinical Trials/NCT06692127
NCT06692127
Recruiting
Not Applicable

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

Rigshospitalet, Denmark5 sites in 2 countries16,000 target enrollmentNovember 2024
ConditionsAtheroslerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atheroslerosis
Sponsor
Rigshospitalet, Denmark
Enrollment
16000
Locations
5
Primary Endpoint
Prevalence of atherosclerosis
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2024
End Date
July 2032
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henning Bundgaard

Professor of Cardiology, consultant, MD, DMSc

Rigshospitalet, Denmark

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.

Outcomes

Primary Outcomes

Prevalence of atherosclerosis

Time Frame: Immediately after the examination.

Prevalence of atherosclerosis using imaging.

Study Sites (5)

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