Actively Recruiting
Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-11-20
1000
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
H
Horizon Innovative Health Initiative
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with type 2 diabetes face a higher risk of heart disease, especially when blood vessels supplying the heart narrow or become blocked by fatty deposits called plaque. This condition can cause serious problems like chest pain or heart attacks. The trial aims to understand how heart disease progresses over time in people with type 2 diabetes by studying changes in their heart's blood vessels using special scans. Participants who have previously had a coronary CT angiography (CCTA) scan will be followed. This scan provides detailed pictures of the heart's blood vessels to detect plaque buildup. Researchers will compare the initial scan with follow-up scans taken between 2 and 5 years later to observe changes in total coronary plaque volume and other related heart health indicators. During the study, participants’ heart scans and health information will be reviewed to track plaque progression and other risk factors. The primary measurement is the change in total plaque volume between the baseline and follow-up scans. Secondary measures include changes in plaque types, calcium scores, and cardiovascular events. The study will continue to monitor cardiovascular events for up to 10 years after enrollment.
CONDITIONS
Brief Title
Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Previous completion of coronary CT angiography (CCTA) scan for coronary artery disease assessment
- Diagnosed with type 2 diabetes and currently receiving glucose lowering treatment
- Sufficient image quality of the CCTA scan (at least 2 out of 3 vessels with good quality for assessment)
You will not qualify if you...
- Unable to provide written informed consent
- Presence of an unstable medical condition
- Severe kidney dysfunction (eGFR ≤ 30 mL/min/1.73m²) or known allergy to CT contrast agents preventing CCTA
- Any other treatment or medical condition that could interfere with the study as judged by the investigator
- Inability or unwillingness to follow the study protocol or deemed unfit by the investigator
- Baseline CCTA performed less than 2 years or more than 5 years before study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 years
Participants undergo coronary CT angiography (CCTA) scans to assess coronary artery disease progression.
1 baseline CCTA and 1 follow-up CCTA visit
Duration - Up to 10 years
Participants are monitored for cardiovascular events following their baseline CCTA for up to 10 years after inclusion.
Visits as needed for cardiovascular event monitoring
Trial Site Locations
Total: 2 locations
1
Amsterdam University Medical Centers
Amsterdam, Netherlands
Not Yet Recruiting
2
Cardiology Centers of the Netherlands
Amsterdam, Netherlands
Actively Recruiting
Research Team
W
Willem R van de Vijver, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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