Atherosclerosis Cardiovascular Disease, Coronary Artery Disease (CAD), Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Horizon Innovative Health Initiative
Novo Nordisk A/S
INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
Cardiology Centers of the Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression of total coronary plaque volume (mm3) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Coronary Artery Disease Reporting and Data Scale(CAD-RADS) scores | 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). |
| Progression of calcified plaque volume (mm3) | Baseline (retrospective) and follow up CCTA (interval 2-5 years) | The progression of total calcified plaque volume |
| Progression of non-calcified plaque volume (mm3) | Baseline (retrospective) and follow up CCTA (interval 2-5 years) | The progression of total non-calcified plaque volume |
| Changes in coronary artery calcium score | Baseline (retrospective) and follow up CCTA (interval 2-5 years) | Change in the coronary artery calcium score |
| Changes in the number of high-risk plaque characteristics | 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). |
| Changes in peri coronary fat attenuation index | Baseline (retrospective) and follow up CCTA (interval 2-5 years) | Change in the peri coronary fat attenuation index |
| The number of cardiovascular events | 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 |
| Progression of low attenuation plaque volume (mm3) | Baseline (retrospective) and follow up CCTA (interval 2-5 years) | The progresison of total low attenuation plaque volume |
Countries
Netherlands
Contacts
Primary ContactWillem R van de Vijver, MD
Outcome results
None listed