Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Type 2 Diabetes Coronary Artery Disease (CAD)Atherosclerosis Cardiovascular Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Between baseline (retrospective) and follow up CCTA (interval 2-5 years).

Secondary Outcomes

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).

Time frame: Between baseline (retrospective) and follow up CCTA (interval 2-5 years)

Progression of calcified plaque volume (mm3)

The progression of total calcified plaque volume