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Type 2 DiabetesEVOLVENCT07237685

Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus

An observational study of Type 2 Diabetes and Coronary Artery Disease (CAD), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
2 sitesNetherlands
Study dates
6 Jun 2025to 1 Oct 2036
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In this study, patients with T2D who previously undergone CCTA for CAD assessment will be recruited. Patients will be included at three clinical sites: Amsterdam UMC, Cardiology centre Netherlands (CCN), University hospital of Salamanca - Fundacion Instituto de Estudios de ciencias de la salud de castilla y leon (IBSAL).

Who may be able to join

  • Age over 18 years
  • Previous completion of CCTA scan for CAD assessment
  • Diagnosed with Type 2 Diabetes and currently receiving glucose lowering treatment
  • Sufficient image quality of the CCTA scan (at least 2/3 vessels of sufficient quality for assessment).

Who cannot join

  • Inability to provide written informed consent
  • Presence of an unstable condition
  • Ingeligibility for CCTA acquisition due to severe renal dysfunction (eGFR ≤ 30 mL/min/1.73m²) or known hypersensitivity or contraindication to CT contrast agents
  • Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
  • inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
  • Baseline (routine care) CCTA performed < 2 years or > 5 years before inclusion

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Willem R van de Vijver, MD contact

+31205662402

w.r.vandevijver@amsterdamumc.nl

Netherlands2 sites, 2 recruiting

  • Amsterdam University Medical Centers

    Amsterdam

    Willem R van de Vijver, +3120-5662402, w.r.vandevijver@amsterdamumc.nl

    Not yet recruiting

  • Cardiology Centers of the Netherlands

    Amsterdam

    Willem R van de Vijver, MD, +3120-5662402, combine-ct@cardiologiecentra.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus

People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death.

This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels.

The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.

Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression of total coronary plaque volume (mm3)

    The primary study parameter will be the progression of total coronary plaque volume (mm3). This will be calculated by subtracting the coronary plaque volume measured in the first CCTA from the total plaque volume measured in the follow-up CCTA. The plaque volume will be determined by dividing the total plaque volume by the total vesssel volume

    Measured: Between baseline (retrospective) and follow up CCTA (interval 2-5 years).

Secondary outcomes (9)

  1. Changes in Coronary Artery Disease Reporting and Data Scale(CAD-RADS) scores

    Change in the percentage of luminal narrowing per lesion as defined by the Coronary Artery Disease Reporting and Data Scale(CAD-RADS) score (minimum 0, maximum 5).

    Measured: Between baseline (retrospective) and follow up CCTA (interval 2-5 years)

  2. Progression of calcified plaque volume (mm3)

    The progression of total calcified plaque volume

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  3. Progression of non-calcified plaque volume (mm3)

    The progression of total non-calcified plaque volume

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  4. Progression of low attenuation plaque volume (mm3)

    The progresison of total low attenuation plaque volume

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  5. Changes in coronary artery calcium score

    Change in the coronary artery calcium score

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  6. Changes in the number of high-risk plaque characteristics

    • Spotty calcium defined as punctate calcium within a plaque
    • Napkin ring sign defined in a non-calcified plaque cross sectional image by the presence of two or more features: a central area of low attenuation plaque that is apparently in contact with the lumen; and a ring like peripheral rim of higher CT attenuation surrounding his central area.
    • Positive remodeling, defined as the ratio of outer vessel diameter at the site of plaque divided by the average outer diameter of the proximal and distal vessel greater than 1.1.
    • Low attenuation plaque, defined as non-calcified plaque with internal attenuation less than 30 Hounsfield units (HU).

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  7. Changes in peri coronary fat attenuation index

    Change in the peri coronary fat attenuation index

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  8. The number of cardiovascular events

    The number of cardiovascular events consisting of:

    • Myocardial infarction (defined as the universal definition as established by the European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and the World health federation)
    • Cerebrovascular accidents (neurologic deficit lasting more than 24 hours or lasting less than 24 hours with a brain imaging study showing infarction)
    • Target vessel revascularization
    • CAD related hospitalization

    Measured: Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  9. The number of cardiovascular events

    Myocardial infarction (defined as the universal definition as established by the European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and the World health federation)

    • Cerebrovascular accidents (neurologic deficit lasting more than 24 hours or lasting less than 24 hours with a brain imaging study showing infarction)
    • Target vessel revascularization
    • CAD related hospitalization

    Measured: Baseline CCTA untill 10 years follow up after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start6 Jun 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2036 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237685
Sponsor's protocol ID
NL86138.018.24
Acronym
EVOLVE
Status last verified
Nov 2025
First submitted
24 Sep 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Coronary Artery Disease (CAD), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?

Contact Willem R van de Vijver, MD (+31205662402, w.r.vandevijver@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression of total coronary plaque volume (mm3) (time frame: Between baseline (retrospective) and follow up CCTA (interval 2-5 years).). 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 NCT07237685.

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 20 Nov 2025.

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