Monitoring coronary artery plaque progression in people with type 2 diabetes.

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

This project will follow adults with type 2 diabetes who already had a coronary CT angiography to see how plaque in their heart arteries changes over time.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 2 sites (Amsterdam and 1 other locations)
• Trial ID: NCT07237685 on ClinicalTrials.gov

What this trial studies

This observational project follows adults with type 2 diabetes who previously underwent coronary CT angiography (CCTA) to track changes in coronary plaque over time. Prior CCTA images that meet quality criteria will be re-analyzed and compared with repeat imaging and routine clinical data collected during follow-up. The study records plaque burden, composition, and progression alongside clinical events and treatments, focusing on participants receiving glucose-lowering therapy. Results aim to improve understanding of how atherosclerotic disease advances in people with diabetes and to identify imaging features that predict future heart problems.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with diagnosed type 2 diabetes on glucose-lowering treatment who have a prior CCTA performed 2–5 years ago with at least two of three coronary vessels imaged at sufficient quality.

Not a fit: Patients with severe renal dysfunction, known contrast allergy, unstable medical conditions, unacceptable image quality, or a baseline CCTA performed outside the 2- to 5-year window are unlikely to be eligible or derive benefit.

Why it matters

Potential benefit: If successful, this work could help doctors identify which patients with type 2 diabetes are at higher risk for worsening coronary artery disease so they can receive earlier or more intensive prevention.

How similar studies have performed: Previous studies using serial coronary CT angiography have demonstrated the ability to detect plaque progression and predict cardiovascular events, but large-scale data specifically focused on progression in treated type 2 diabetes patients remain limited.

Eligibility criteria

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

Where this trial is running

Amsterdam and 1 other locations

• Amsterdam University Medical Centers — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• Cardiology Centers of the Netherlands — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Willem R van de Vijver, MD

Conditions: Type 2 Diabetes, Coronary Artery Disease, Atherosclerosis Cardiovascular Disease