clogged arteries of the heart Coronary artery disease blocked heart arteries
Conditions
Interventions
Niet van toepassing
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age over 18 years. - Previous completion of a CCTA scan for CAD assessment. - Diagnosed with Diabetes Mellitus type 2 and currently receiving glucose lowering treatment. - Sufficient image quality of the CCTA scan at baseline (at least 2/3 vessels of sufficient quality for assessment).
Exclusion criteria
Exclusion criteria: - Inability to provide written informed consent. - Presence of an unstable condition at time of baseline or follow up CT, including but not limited to: 1) Acute coronary syndrome 2) Hemodynamic instability. 3) Uncontrolled or recurrent ventricular tachy-arrhythmias. - Ineligibility for CCTA due to: 1) Severe renal dysfunction (eGFR <= 30 mL/min/1.73m²). 2) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The progression of total coronary plaque volume | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary parameters and endpoints will be studied: • Presence of obstructive coronary artery disease on CCTA. • Number of patients who underwent invasive angiography. • Number of percutaneous coronary interventions (PCI) or Coronary Artery Bypass Grafting (CABG) procedures. • If performed, results from additional stress testing (e.g. single photon emis-sion computed tomography, myocardial perfusion positron emission tomog-raphy, stress magnetic resonance imaging, stress echocardiography) • Progression of calcified plaque volume (mm3). • Progression of non-calcified plaque volume (mm3). • Progression of low attenuation plaque volume (mm3) • Changes in coronary artery calcium score (Agatston Units) • Changes in CAD-RADS scores (as stated by the CAD-RADS expert consensus document): • Changes in the number of high-risk plaque characteristics as defined by the CAD-RADS expert consensus document • Changes in peri coronary fat attenuation index (HU). • CT derived fractional flow reserve (CT-FFR) • Biochemical biomarkers: e.g. total cholesterol, LDL, LDL, HDL, triglycerides, NT-proBNP, CRP, HbA1c, creatinine, serum glucose, lipoprotein a, apolipoprotein B, hemoglobin, leukocytes • The number of cardiovascular events (all cause death, 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 accident (neurologic deficit lasting more than 24 hours or lasting less than 24 hours with a brain imaging study showing infarction, hospitalization for unsta-ble angina, target vessel revascularization, CAD related hospitalization). | — |
Countries
Netherlands, Spain
Contacts
Public ContactW.R. Vijver
Amsterdam UMC
Outcome results
None listed