RecruitingRecruiting
Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus
NCT07237685 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus
About this study
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.
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
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-06-06
Estimated completion: 2036-10-01
Last updated: 2025-11-20
Primary outcomes
- • progression of total coronary plaque volume (mm3) (Between baseline (retrospective) and follow up CCTA (interval 2-5 years).)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · other
With: Horizon Innovative Health Initiative, Novo Nordisk A/S, INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL), Cardiology Centers of the Netherlands
Contacts & investigators
ContactWillem R van de Vijver, MD · contact · w.r.vandevijver@amsterdamumc.nl · +31205662402
All locations (2)
Amsterdam University Medical CentersNot Yet Recruiting
Amsterdam, Netherlands
Cardiology Centers of the NetherlandsRecruiting
Amsterdam, Netherlands