To describe the natural history of coronary artery disease in patients with diabetes mellitus type 2 through the use of serial CCTA, providing a comprehensive understanding of disease progression and its clinical implications over time.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The progression of total coronary plaque volume
Secondary outcome
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, troponin, 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).
Background summary
Patients with type 2 diabetes (T2D) face a significantly increased risk of
coronary artery disease (CAD), with up to 80% ultimately dying from
cardiovascular causes. This is driven by underlying mechanisms such as insulin
resistance, hypertension, and dyslipidemia, which contribute to accelerated
atherosclerosis and higher rates of adverse cardiovascular events. Early
detection and management of CAD in T2D is crucial. Coronary computed tomography
angiography (CCTA) biomarkers have been shown to predict plaque progression and
major cardiovascular events (MACE) in T2D patients. Advancements in imaging
technologies, such as photon-counting CT, have further improved diagnostic
accuracy. This study aims to investigate the natural history of CAD in patients
with T2D, integrating traditional risk factors, biochemical and imaging
biomarkers to better predict plaque progression and MACE, providing a more
comprehensive approach to cardiovascular risk management in this population.
Study objective
To describe the natural history of coronary artery disease in patients with
diabetes mellitus type 2 through the use of serial CCTA, providing a
comprehensive understanding of disease progression and its clinical
implications over time.
Study design
multicentre, observational, prospective, cohort study
Study burden and risks
The results can contribute to improved CAD risk stratification in patients with
stable chest pain identifying patients at high-risk for CAD. Participating
subjects have no direct clinical benefits from participation. However, the
expected risk is low. The most important risk is radiation exposure. Despite
that, the maximum exposure related to CCTA is 1.4 mSv, which is lower than the
yearly dose of background radiation. Ionized contrast agents will be used which
can be nephrotoxic and may elicit allergic reactions.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86138.018.24 |