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NCT Number: NCT07237685

Evaluating Atherosclerotic Disease Progression in 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.

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Key information

Conditions

Type 2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Disease Cardiovascular Diseases Coronary Artery Disease Coronary Artery Disease (CAD) Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centers, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. progression of total coronary plaque volume (mm3)

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

    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

Secondary outcomes

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

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

    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).

  2. Progression of calcified plaque volume (mm3)

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

    The progression of total calcified plaque volume

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

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

    The progression of total non-calcified plaque volume

  4. Progression of low attenuation plaque volume (mm3)

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

    The progresison of total low attenuation plaque volume

  5. Changes in coronary artery calcium score

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

    Change in the coronary artery calcium score

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

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

    • 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).

  7. Changes in peri coronary fat attenuation index

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

    Change in the peri coronary fat attenuation index

  8. The number of cardiovascular events

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

    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

  9. The number of cardiovascular events

    Time frame: Baseline CCTA untill 10 years follow up after inclusion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Willem R van de Vijver, MD

CONTACT

[email protected]

+31205662402

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Cardiology Centers of the Netherlands
  • Horizon Innovative Health Initiative
  • INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: EVOLVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2036
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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