coronary artery disease coronary artery stenoses
Conditions
Interventions
None listed
Sponsors
Persuasive dx
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The subject is >= 18 years of age • The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up • The subject has (recurrent) angina pectoris or an equivalent, suspected of stable coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g., ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes. • The subject will undergo a >=64 multidetector row CCTA (with contrast) as part of usual care deemed by the treating physician.
Exclusion criteria
Exclusion criteria: • The subject does not or is not able to comply with those imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT)1 established to obtain good image quality, including: o The subject is morbidly obese (Body Mass Index (BMI) > 40). o The subject is not able to sustain a breath-hold for 25 seconds. • The subject is unable to remain in supine position for at least 30 minutes • The subject is suffering from unstable angina pectoris. • The subject is suffering from decompensated congestive cardiac failure. • The subject is suffering from a known or suspected non-ischemic cardiomyopathy. • The subject has a history of Percutaneous Coronary Intervention (PCI) or coronary artery bypass grafting (CABG). • The subject currently has pacemaker- or internal defibrillator leads implanted. • The subject has a prosthetic heart valve. • The subject is suffering from (auto)immune disorders • The subject is suffering from an active malignancies and/or currently receives treatment for a malignancy • The subject is currently receiving oral, systemic or long-term cutaneous steroid therapy, or any other oral or systemic immune-suppressive medications. • The subject is currently receiving therapeutic anticoagulants, such as direct oral anticoagulants, vitamin K antagonists, heparin or low molecular weight heparin. Patients taking thrombocyte aggregation inhibitors and prophylactic anticoagulants are allowed to participate. • The subject is suffering from a coagulation disorder • The subject is or might be pregnant. • The subject participates in any other clinical trial that interferes with the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter: plasma EV proteins for obstructive coronary artery disease in patients presenting with CCS-like symptoms in the cardiology outpatient department. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints are: • To assess the added value of other plasma EV biomarkers associated with inflammation and/or coagulation and cardiovascular disease to plasma EV proteins in detection of CCS. • To assess prediction of myocardial ischemia and revascularization with plasma EV proteins and with (addition of) other plasma EV biomarkers associated with inflammation and/or coagulation. • To assess identification of high-risk CCS patients with plasma EV proteins and plasma (EV) biomarkers associated with inflammation and/or coagulation (plaque burden P3 or P4, or with plaque vulnerability (HRP) according to CAD-RADS 2.0). • To compare the diagnostic and prognostic value of plasma EV proteins and plasma (EV) biomarkers associated with inflammation and/or coagulation with calcium scoring. • Comparison with ICA/FFR. • To compare and assess the prognostic value of plasma EV proteins and plasma (EV) biomarkers associated with inflammation and/or coagulation during the 30 month follow up: 1) In planned revascularization procedures due to obstructive CAD; 2) In all-cause mortality; 3) in Major Adverse Cardiac Events (MACE), which comprises a) Cardiovascular mortality, b) aborted sudden cardiac death, c) Myocardial Infarction (MI); d) Unplanned hospitalization for chest pain leading to urgent revascularization; e) Stroke. | — |
Countries
Netherlands
Outcome results
None listed