Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial population
In this study, patients with T2D who previously undergone CCTA for CAD assessment will be recruited. Patients will be included at three clinical sites: Amsterdam UMC, Cardiology centre Netherlands (CCN), University hospital of Salamanca - Fundacion Instituto de Estudios de ciencias de la salud de castilla y leon (IBSAL).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
1
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)2
Progression of calcified plaque volume (mm3)
The progression of total calcified plaque volume
Time frame
Baseline (retrospective) and follow up CCTA (interval 2-5 years)3
Progression of non-calcified plaque volume (mm3)
The progression of total non-calcified plaque volume
Time frame
Baseline (retrospective) and follow up CCTA (interval 2-5 years)4
Progression of low attenuation plaque volume (mm3)
The progresison of total low attenuation plaque volume
Time frame
Baseline (retrospective) and follow up CCTA (interval 2-5 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Horizon Innovative Health Initiative
Collaborator
Novo Nordisk A/S
Collaborator
INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
Collaborator
Cardiology Centers of the Netherlands
Collaborator
Source ClinicalTrials.gov