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

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: Recruiting
• Conditions: Type 2 Diabetes; Coronary Artery Disease (CAD); Atherosclerosis Cardiovascular Disease

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Willem R van de Vijver, MD; Phone Number: +31205662402; Email: w.r.vandevijver@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • Amsterdam University Medical Centers
    • Contact: Willem R van de Vijver; Phone Number: +3120-5662402; Email: w.r.vandevijver@amsterdamumc.nl
  • Amsterdam, Netherlands
    • Recruiting
    • Cardiology Centers of the Netherlands
    • Contact: Willem R van de Vijver, MD; Phone Number: +3120-5662402; Email: combine-ct@cardiologiecentra.nl

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Between baseline (retrospective) and follow up CCTA (interval 2-5 years).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Between baseline (retrospective) and follow up CCTA (interval 2-5 years)
Progression of calcified plaque volume (mm3)	The progression of total calcified plaque volume	Baseline (retrospective) and follow up CCTA (interval 2-5 years)
Progression of non-calcified plaque volume (mm3)	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)	The progresison of total low attenuation plaque volume	Baseline (retrospective) and follow up CCTA (interval 2-5 years)
Changes in coronary artery calcium score	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	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	Change in the peri coronary fat attenuation index	Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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	Baseline (retrospective) and follow up CCTA (interval 2-5 years)
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	Baseline CCTA untill 10 years follow up after inclusion

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Novo Nordisk A/S; INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL); Horizon Innovative Health Initiative; Cardiology Centers of the Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2036

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Coronary Artery Disease
• Other Study ID 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