Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus (EVOLVE)

November 18, 2025 updated by: M.M. Winter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Amsterdam University Medical Centers
        • Contact:
      • Amsterdam, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Between baseline (retrospective) and follow up CCTA (interval 2-5 years).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Between baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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).
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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
Baseline CCTA untill 10 years follow up after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S
INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
Horizon Innovative Health Initiative
Cardiology Centers of the Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL86138.018.24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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