AtherosclerosisDETECTNCT06692127
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT
An observational study of Atherosclerosis and Subclinical Atherosclerosis, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Subclinical Atherosclerosis, Cardiovascular Diseases
- How many people
- 16,808 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 27 Nov 2024to Jul 2032
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Danish and Spanish adults 18-70 years of age of predominantly European ancestry without known atherosclerotic cardiovascular disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark4 sites
Rigshospitalet
Copenhagen, 2100
Righospitalet - Glostrup Hospital
Glostrup Municipality, 2600
Herlev Hospital
Herlev, 2730
Regionshospitalet Gødstrup
Herning, 7400
Spain1 site
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)
Madrid, E-28029
About this study
Official 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
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.
Read more
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.
Read the 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.
- Keywords
- REACT, DETECT, Silent atherosclerosis, Primary prevention, Vascular ultrasound, Coronary CT angiography
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of silent atherosclerosis (plaque in at least one vascular territory)
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.
Measured: At the baseline imaging visit (cross-sectional).
Secondary outcomes (5)
Presence of plaque in each vascular territory
Presence of atherosclerotic plaque in the carotid, femoral, and coronary territories, reported separately.
Measured: At the baseline imaging visit (cross-sectional).
Plaque volume in each vascular territory
Atherosclerotic plaque volume (mm3) in the carotid, femoral, and coronary territories, reported separately.
Measured: At the baseline imaging visit (cross-sectional).
Global peripheral plaque volume
Sum of atherosclerotic plaque volume (mm3) across the carotid and femoral (peripheral) territories.
Measured: At the baseline imaging visit (cross-sectional).
Coronary plaque volume
Total coronary atherosclerotic plaque volume (mm3) assessed by coronary computed tomography angiography.
Measured: At the baseline imaging visit (cross-sectional).
Coronary artery calcium score (CACS)
Coronary artery calcium score (Agatston units) assessed by non-contrast computed tomography.
Measured: At the baseline imaging visit (cross-sectional).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start27 Nov 2024
- Primary completion3 Jul 2026
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,808 participants (actual)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Gødstrup Hospital, Herlev and Gentofte Hospital, Novo Nordisk Foundation
- Responsible party
- Principal investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henning Bundgaard, MD, DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletBorja Ibanez, MD, PhD, Principal investigator, CNIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692127
- Sponsor's protocol ID
- RH-DETECT
- Other IDs
- H-24047468, 76_20242024
- Acronym
- DETECT
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bundgaard H, Garcia-Lunar I, Kofoed KF, Hasselbalch R, Perez-Garcia CN, Kunkel JB, Staeger FF, Sanchez-Cabo F, Fuster JJ, Mass V, Sanchez-Gonzalez J, Kragh MV, Ringgaard AK, Valls-Monzo J, Pham MHC, Devesa A, Sejer M, Sigvardsen P, Quesada A, Eberhard C, Garcia-Alvarez A, Pehrson LM, Navarro-Guzman A, Winther S, Sorgaard M, Gamez M, Lundsgaard M, Perez-Herreras C, Frikke-Schmidt R, Sanchez PL, Eldrup N, Torres-Macho J, Bottcher M, Fuster V, Iversen KK, Ibanez B; REACT Investigators. Prevalence of Silent Atherosclerosis across Adult Life. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2609059. Online ahead of print.
PubMed 42670946
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06692127
- Acronym / sponsor ID
- DETECT / RH-DETECT
- Keywords
- REACT, DETECT, Silent atherosclerosis, Primary prevention, Vascular ultrasound, Coronary CT angiography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 16,808 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Gødstrup Hospital, Herlev and Gentofte Hospital, Novo Nordisk Foundation
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- Jul 2032 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Danish and Spanish adults 18-70 years of age of predominantly European ancestry without known atherosclerotic cardiovascular disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Presence of plaque in each vascular territory
Time frame: At the baseline imaging visit (cross-sectional).
Plaque volume in each vascular territory
Time frame: At the baseline imaging visit (cross-sectional).
Global peripheral plaque volume
Time frame: At the baseline imaging visit (cross-sectional).
Coronary plaque volume
Time frame: At the baseline imaging visit (cross-sectional).
Coronary artery calcium score (CACS)
Time frame: At the baseline imaging visit (cross-sectional).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 42670946Bundgaard H, Garcia-Lunar I, Kofoed KF, Hasselbalch R, Perez-Garcia CN, Kunkel JB, Staeger FF, Sanchez-Cabo F, Fuster JJ, Mass V, Sanchez-Gonzalez J, Kragh MV, Ringgaard AK, Valls-Monzo J, Pham MHC, Devesa A, Sejer M, Sigvardsen P, Quesada A, Eberhard C, Garcia-Alvarez A, Pehrson LM, Navarro-Guzman A, Winther S, Sorgaard M, Gamez M, Lundsgaard M, Perez-Herreras C, Frikke-Schmidt R, Sanchez PL, Eldrup N, Torres-Macho J, Bottcher M, Fuster V, Iversen KK, Ibanez B; REACT Investigators. Prevalence of Silent Atherosclerosis across Adult Life. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2609059. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bundgaard, MD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Borja Ibanez, MD, PhD principal investigator
CNIC
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Subclinical Atherosclerosis, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of silent atherosclerosis (plaque in at least one vascular territory) (time frame: At the baseline imaging visit (cross-sectional).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.