Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Coronary Artery Disease (CAD), Atherosclerosis Cardiovascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus
Overview
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.
Primary outcome measures
- progression of total coronary plaque volume (mm3) [Time frame: Between baseline (retrospective) and follow up CCTA (interval 2-5 years).]
Secondary outcome measures (9)
- 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)]
- Progression of calcified plaque volume (mm3) [Time frame: 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)]
- Progression of low attenuation plaque volume (mm3) [Time frame: 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)]
- Changes in the number of high-risk plaque characteristics [Time frame: 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)]
- The number of cardiovascular events [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam University Medical Centers — Amsterdam
- Cardiology Centers of the Netherlands — Amsterdam
Identifiers
NCT: NCT07237685 · NL86138.018.24