Coronary Artery DiseaseMARC-3NCT07625488
Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)
An observational study of Coronary Artery Disease and Atherosclerosis, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Regular endurance exercise is widely known to improve cardiovascular health and reduce the risk of heart disease. Yet several imaging studies have shown that male endurance athletes have a higher prevalence of coronary artery calcification (CAC) and calcified plaque than less active individuals. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- How many people
- 250 participants
- Where
- 2 sitesNetherlands
- Study dates
- 31 May 2026to 31 Dec 2027
- 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 45 years and older
- Men only
- Adult, Older adult
Study population: Participants are invited from the established MARC cohort, which originally included 318 Caucasian, middle-aged (≥45 years) male amateur athletes recruited between 2012 and 2014. At baseline, athletes were eligible if they engaged in regular endurance exercise and were free of known cardiovascular disease. All participants underwent a comprehensive sports medical evaluation without abnormalities prior to enrollment. The initial exclusion criteria included inability to provide informed consent and medical conditions precluding participation in exercise testing or CT imaging.
Who may be able to join
- Previous participation in the original MARC study (enrolled between 2012-2014).
Who cannot join
- Inability to provide written informed consent.
- Not willing to receive information about potential incidental CT findings.
- Concurrent participation in an interventional study targeting cardiovascular health.
- Additional exclusion criteria for CCTA:
- Not willing to undergo CCTA with intravenous contrast.
- History of severe allergic reaction to iodinated contrast agents.
Show all 25Show fewer
- Renal dysfunction (eGFR < 30 mL/min/1.73 m²).
- Additional exclusion criteria for maximal exercise testing:
- Absolute contraindications to maximal exercise testing as defined by institutional SOPs, including but not limited to:
- Recent acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias with symptoms or hemodynamic compromise
- Syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction
- Lower extremity thrombosis
- Suspected aortic dissection
- Uncontrolled asthma
- Pulmonary edema
- Resting room-air oxygen saturation ≤ 85 percent
- Respiratory failure
- Acute non-cardiopulmonary disorders that impair or are aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)
- Mental impairment preventing cooperation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
Radboud University Medical Center
Nijmegen, 6525 GA
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Regular endurance exercise is widely known to improve cardiovascular health and reduce the risk of heart disease. Yet several imaging studies have shown that male endurance athletes have a higher prevalence of coronary artery calcification (CAC) and calcified plaque than less active individuals. It remains unclear whether this represents harmful progression of coronary artery disease or a more benign, stable form of atherosclerosis. Understanding this distinction is essential, because coronary atherosclerosis is the leading cause of exercise-related cardiac events in athletes >35 years.
The MARC-3 study is the second long-term follow-up of the original Measuring Athlete's Risk of Cardiovascular Events (MARC) cohort and aims to clarify how lifelong exercise training influences coronary artery health.
Read more
The study will:
- examine how long-term exercise patterns relate to the progression of coronary atherosclerosis;
- assess plaque characteristics using artificial-intelligence based quantitative coronary CT angiography (AI-QCT);
- identify biological markers that may link exercise to plaque development; and
- evaluate long-term clinical outcomes, including all-cause mortality and major adverse cardiovascular events (MACE).
Our working hypothesis is that endurance exercise predominantly leads to more stable, calcified plaque, and that mechanisms such as exercise-induced hypertension, inflammation, lipid regulation, and genetic background may provide an explanation for the unexpected results observed in previous studies.
Read the detailed description
For a detailed description, please see the attached study protocol under 'Documents'.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Exercise, Physical Activity, Coronary Artery Calcification, Plaque, Atherosclerotic, Coronary Computed Tomography Angiography, AI-based Quantitative Computed Tomography, Pericoronary Adipose Tissue Attenuation, Vascular Inflammation, Biomarkers, Genetic Predisposition to Disease, Polygenic Risk Score, Major Adverse Cardiovascular Events
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Motor Activity, Plaque, Atherosclerotic, Genetic Predisposition to Disease, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MARC-3 cohort | Participants in this cohort are the surviving and traceable members of the original MARC study, which enrolled 318 middle-aged male amateur endurance athletes between 2012 and 2014. In the first follow-up (MARC-2), 291 participants were successfully re-examined. All participants have a lifelong history of regular endurance exercise. In MARC-3, they undergo repeat evaluation of coronary atherosclerosis, cardiopulmonary fitness, exercise exposure, biomarkers, and genetic factors approximately 12.5 years after baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcium (CAC) Score
Total CACS (AU)
AU: Agatston units
Measured: Baseline
Coronary stenosis and plaque characteristics
Determine the characteristics (burden, composition, risk features)
Measured: Baseline
Secondary outcomes (4)
Quantitative Plaque Phenotype and Burden
Total plaque volume (mm³); calcified, mixed, non-calcified and low-attenuation plaque (mm³); remodeling index.
Measured: Baseline
Pericoronary Adipose Tissue Attenuation (PCATa)
CCTA-derived PCAT attenuation around proximal coronary arteries (Hounsfield Units, HU).
Measured: Baseline
Peripheral Atherosclerosis and Vascular Function
Carotid artery intima-media thickness (IMT, mm)
Measured: Baseline
Long-Term Clinical Outcomes
All-cause mortality and major adverse cardiac events (MACE)
Measured: Through current study baseline, approximately 13 years after initial cohort enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start31 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Collaborators within FIT-HEART consortium (e.g. UMC Utrecht, Amsterdam UMC), Cleerly, Inc., Caristo Ltd., Philips Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625488
- Sponsor's protocol ID
- MARC-3
- Other IDs
- #01-001-2024-0621, 4334294-1093118-PG
- Acronym
- MARC-3
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymised individual participant data underlying published results may be made available to qualified researchers upon reasonable request. Data access will be subject to approval by the study group leaders, compatibility with participant consent, institutional privacy/legal review, and execution of a data sharing agreement. Only data necessary for the approved research question will be shared.
Publications
Braber TL, Mosterd A, Prakken NH, Doevendans PA, Mali WP, Backx FJ, Grobbee DE, Rienks R, Nathoe HM, Bots ML, Velthuis BK. Rationale and design of the Measuring Athlete's Risk of Cardiovascular events (MARC) study : The role of coronary CT in the cardiovascular evaluation of middle-aged sportsmen. Neth Heart J. 2015 Feb;23(2):133-8. doi: 10.1007/s12471-014-0630-0.
PubMed 25410576Braber TL, Prakken NH, Mosterd A, Mali WP, Doevendans PA, Bots ML, Velthuis BK. Identifying Coronary Artery Disease in Asymptomatic Middle-Aged Sportsmen: The Additional Value of Pulse Wave Velocity. PLoS One. 2015 Jul 6;10(7):e0131895. doi: 10.1371/journal.pone.0131895. eCollection 2015.
PubMed 26147752Braber TL, Mosterd A, Prakken NH, Rienks R, Nathoe HM, Mali WP, Doevendans PA, Backx FJ, Bots ML, Grobbee DE, Velthuis BK. Occult coronary artery disease in middle-aged sportsmen with a low cardiovascular risk score: The Measuring Athlete's Risk of Cardiovascular Events (MARC) study. Eur J Prev Cardiol. 2016 Oct;23(15):1677-84. doi: 10.1177/2047487316651825. Epub 2016 May 24.
PubMed 27222386Schurink MM, Braber TL, Prakken NH, Doevendans PA, Backx FJ, Grobbee DE, Rienks R, Nathoe HM, Bots ML, Velthuis BK, Mosterd A. No psychological distress in sportsmen aged 45 years and older after cardiovascular screening, including cardiac CT: The Measuring Athlete's Risk of Cardiovascular events (MARC) study. Neth Heart J. 2017 Apr;25(4):271-277. doi: 10.1007/s12471-017-0948-5.
PubMed 28144819Aengevaeren VL, Mosterd A, Braber TL, Prakken NHJ, Doevendans PA, Grobbee DE, Thompson PD, Eijsvogels TMH, Velthuis BK. Relationship Between Lifelong Exercise Volume and Coronary Atherosclerosis in Athletes. Circulation. 2017 Jul 11;136(2):138-148. doi: 10.1161/CIRCULATIONAHA.117.027834. Epub 2017 Apr 27.
PubMed 28450347Aengevaeren VL, Mosterd A, Sharma S, Braber TL, Thompson PD, Velthuis BK, Eijsvogels TMH. Coronary Atherosclerosis in Athletes: Exploring the Role of Sporting Discipline. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1587-1589. doi: 10.1016/j.jcmg.2019.01.002. Epub 2019 Feb 13. No abstract available.
PubMed 30772217Berge K, Aengevaeren VL, Mosterd A, Velthuis BK, Lyngbakken MN, Omland T, Schalkwijk CG, Eijsvogels TMH. Plasma Advanced Glycation End Products and Dicarbonyl Compounds Are Not Associated with Coronary Atherosclerosis in Athletes. Med Sci Sports Exerc. 2023 Jul 1;55(7):1143-1150. doi: 10.1249/MSS.0000000000003152. Epub 2023 Apr 4.
PubMed 36849122Janssen SLJE, de Vries F, Mingels AMA, Kleinnibbelink G, Hopman MTE, Mosterd A, Velthuis BK, Aengevaeren VL, Eijsvogels TMH. Exercise-induced cardiac troponin release in athletes with versus without coronary atherosclerosis. Am J Physiol Heart Circ Physiol. 2024 Apr 1;326(4):H1045-H1052. doi: 10.1152/ajpheart.00021.2024. Epub 2024 Feb 16.
PubMed 38363583Berge K, Janssen SLJE, Velthuis BK, Myhre PL, Mosterd A, Omland T, Eijsvogels TMH, Aengevaeren VL. Predictors of coronary atherosclerosis in middle-aged and older athletes: the MARC-2 study. Eur Heart J Cardiovasc Imaging. 2025 Mar 3;26(3):461-470. doi: 10.1093/ehjci/jeae317.
PubMed 39657626Janssen SLJE, Aengevaeren VL, DE Vries F, Kleinnibbelink G, Mingels AMA, Hopman MTE, Mosterd A, Velthuis BK, Riksen NP, Eijsvogels TMH. Exercise-Induced Changes in Hemodynamics, Hormones, Electrolytes, and Inflammatory Markers in Veteran Athletes with and without Coronary Atherosclerosis. Med Sci Sports Exerc. 2025 Jul 1;57(7):1297-1308. doi: 10.1249/MSS.0000000000003674. Epub 2025 Feb 17.
PubMed 39957063
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)
- ClinicalTrials.gov ID
- NCT07625488
- Acronym / sponsor ID
- MARC-3 / MARC-3
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Exercise, Physical Activity, Coronary Artery Calcification, Plaque, Atherosclerotic, Coronary Computed Tomography Angiography, AI-based Quantitative Computed Tomography, Pericoronary Adipose Tissue Attenuation, Vascular Inflammation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Collaborators within FIT-HEART consortium (e.g. UMC Utrecht, Amsterdam UMC), Cleerly, Inc., Caristo Ltd., Philips Healthcare
- Study start
- 31 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
Regular endurance exercise is widely known to improve cardiovascular health and reduce the risk of heart disease. Yet several imaging studies have shown that male endurance athletes have a higher prevalence of coronary artery calcification (CAC) and calcified plaque than less active individuals. It remains unclear whether this represents harmful progression of coronary artery disease or a more benign, stable form of atherosclerosis. Understanding this distinction is essential, because coronary atherosclerosis is the leading cause of exercise-related cardiac events in athletes >35 years.
The MARC-3 study is the second long-term follow-up of the original Measuring Athlete's Risk of Cardiovascular Events (MARC) cohort and aims to clarify how lifelong exercise training influences coronary artery health.
The study will:
- examine how long-term exercise patterns relate to the progression of coronary atherosclerosis;
- assess plaque characteristics using artificial-intelligence based quantitative coronary CT angiography (AI-QCT);
- identify biological markers that may link exercise to plaque development; and
- evaluate long-term clinical outcomes, including all-cause mortality and major adverse cardiovascular events (MACE).
Our working hypothesis is that endurance exercise predominantly leads to more stable, calcified plaque, and that mechanisms such as exercise-induced hypertension, inflammation, lipid regulation, and genetic background may provide an explanation for the unexpected results observed in previous studies.
Detailed description
For a detailed description, please see the attached study protocol under 'Documents'.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MARC-3 cohort | – | –Participants in this cohort are the surviving and traceable members of the original MARC study, which enrolled 318 middle-aged male amateur endurance athletes between 2012 and 2014. In the first follow-up (MARC-2), 291 participants were successfully re-examined. All participants have a lifelong history of regular endurance exercise. In MARC-3, they undergo repeat evaluation of coronary atherosclerosis, cardiopulmonary fitness, exercise exposure, biomarkers, and genetic factors approximately 12.5 years after baseline. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Participants are invited from the established MARC cohort, which originally included 318 Caucasian, middle-aged (≥45 years) male amateur athletes recruited between 2012 and 2014. At baseline, athletes were eligible if they engaged in regular endurance exercise and were free of known cardiovascular disease. All participants underwent a comprehensive sports medical evaluation without abnormalities prior to enrollment. The initial exclusion criteria included inability to provide informed consent and medical conditions precluding participation in exercise testing or CT imaging.
Key inclusion criteria (1 listed)
- Previous participation in the original MARC study (enrolled between 2012-2014).
Key exclusion criteria (25 listed)
- Inability to provide written informed consent.
- Not willing to receive information about potential incidental CT findings.
- Concurrent participation in an interventional study targeting cardiovascular health.
- Not willing to undergo CCTA with intravenous contrast.
- History of severe allergic reaction to iodinated contrast agents.
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
Coronary Artery Calcium (CAC) Score
Time frame: Baseline
Total CACS (AU) AU: Agatston units
Coronary stenosis and plaque characteristics
Time frame: Baseline
Determine the characteristics (burden, composition, risk features)
4 secondary outcomes
Quantitative Plaque Phenotype and Burden
Time frame: Baseline
Pericoronary Adipose Tissue Attenuation (PCATa)
Time frame: Baseline
Peripheral Atherosclerosis and Vascular Function
Time frame: Baseline
Long-Term Clinical Outcomes
Time frame: Through current study baseline, approximately 13 years after initial cohort enrollment
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 13 Aug 2026.
- Results publication: PubMed 25410576Braber TL, Mosterd A, Prakken NH, Doevendans PA, Mali WP, Backx FJ, Grobbee DE, Rienks R, Nathoe HM, Bots ML, Velthuis BK. Rationale and design of the Measuring Athlete's Risk of Cardiovascular events (MARC) study : The role of coronary CT in the cardiovascular evaluation of middle-aged sportsmen. Neth Heart J. 2015 Feb;23(2):133-8. doi: 10.1007/s12471-014-0630-0.
- Results publication: PubMed 26147752Braber TL, Prakken NH, Mosterd A, Mali WP, Doevendans PA, Bots ML, Velthuis BK. Identifying Coronary Artery Disease in Asymptomatic Middle-Aged Sportsmen: The Additional Value of Pulse Wave Velocity. PLoS One. 2015 Jul 6;10(7):e0131895. doi: 10.1371/journal.pone.0131895. eCollection 2015.
- Results publication: PubMed 27222386Braber TL, Mosterd A, Prakken NH, Rienks R, Nathoe HM, Mali WP, Doevendans PA, Backx FJ, Bots ML, Grobbee DE, Velthuis BK. Occult coronary artery disease in middle-aged sportsmen with a low cardiovascular risk score: The Measuring Athlete's Risk of Cardiovascular Events (MARC) study. Eur J Prev Cardiol. 2016 Oct;23(15):1677-84. doi: 10.1177/2047487316651825. Epub 2016 May 24.
- Results publication: PubMed 28144819Schurink MM, Braber TL, Prakken NH, Doevendans PA, Backx FJ, Grobbee DE, Rienks R, Nathoe HM, Bots ML, Velthuis BK, Mosterd A. No psychological distress in sportsmen aged 45 years and older after cardiovascular screening, including cardiac CT: The Measuring Athlete's Risk of Cardiovascular events (MARC) study. Neth Heart J. 2017 Apr;25(4):271-277. doi: 10.1007/s12471-017-0948-5.
- Results publication: PubMed 28450347Aengevaeren VL, Mosterd A, Braber TL, Prakken NHJ, Doevendans PA, Grobbee DE, Thompson PD, Eijsvogels TMH, Velthuis BK. Relationship Between Lifelong Exercise Volume and Coronary Atherosclerosis in Athletes. Circulation. 2017 Jul 11;136(2):138-148. doi: 10.1161/CIRCULATIONAHA.117.027834. Epub 2017 Apr 27.
- Results publication: PubMed 30772217Aengevaeren VL, Mosterd A, Sharma S, Braber TL, Thompson PD, Velthuis BK, Eijsvogels TMH. Coronary Atherosclerosis in Athletes: Exploring the Role of Sporting Discipline. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1587-1589. doi: 10.1016/j.jcmg.2019.01.002. Epub 2019 Feb 13. No abstract available.
- Results publication: PubMed 36849122Berge K, Aengevaeren VL, Mosterd A, Velthuis BK, Lyngbakken MN, Omland T, Schalkwijk CG, Eijsvogels TMH. Plasma Advanced Glycation End Products and Dicarbonyl Compounds Are Not Associated with Coronary Atherosclerosis in Athletes. Med Sci Sports Exerc. 2023 Jul 1;55(7):1143-1150. doi: 10.1249/MSS.0000000000003152. Epub 2023 Apr 4.
- Results publication: PubMed 38363583Janssen SLJE, de Vries F, Mingels AMA, Kleinnibbelink G, Hopman MTE, Mosterd A, Velthuis BK, Aengevaeren VL, Eijsvogels TMH. Exercise-induced cardiac troponin release in athletes with versus without coronary atherosclerosis. Am J Physiol Heart Circ Physiol. 2024 Apr 1;326(4):H1045-H1052. doi: 10.1152/ajpheart.00021.2024. Epub 2024 Feb 16.
- Results publication: PubMed 39657626Berge K, Janssen SLJE, Velthuis BK, Myhre PL, Mosterd A, Omland T, Eijsvogels TMH, Aengevaeren VL. Predictors of coronary atherosclerosis in middle-aged and older athletes: the MARC-2 study. Eur Heart J Cardiovasc Imaging. 2025 Mar 3;26(3):461-470. doi: 10.1093/ehjci/jeae317.
- Results publication: PubMed 39957063Janssen SLJE, Aengevaeren VL, DE Vries F, Kleinnibbelink G, Mingels AMA, Hopman MTE, Mosterd A, Velthuis BK, Riksen NP, Eijsvogels TMH. Exercise-Induced Changes in Hemodynamics, Hormones, Electrolytes, and Inflammatory Markers in Veteran Athletes with and without Coronary Atherosclerosis. Med Sci Sports Exerc. 2025 Jul 1;57(7):1297-1308. doi: 10.1249/MSS.0000000000003674. Epub 2025 Feb 17.
- Individual participant dataSharing planned: Yes. Pseudonymised individual participant data underlying published results may be made available to qualified researchers upon reasonable request. Data access will be subject to approval by the study group leaders, compatibility with participant consent, institutional privacy/legal review, and execution of a data sharing agreement. Only data necessary for the approved research question will be shared.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Radboud University Medical Center at 2 sites in Netherlands.
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 1 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Coronary Artery Calcium (CAC) Score (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT07625488, which also lists 10 linked publications.
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 13 Aug 2026.