Coronary artery disease
Conditions
Interventions
- CT-derived FFR: CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree
- Angiography-derived FFR: FFR-values are calculated during coronary angiography based o
Sponsors
St. Antonius Hospital
Eligibility
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 the clinical suspicion of having (recurrent) angina pectoris or an equivalent and suspected 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 has had =64 multidetector row coronary CTA as part of usual care deemed by the treating physician which shows possibly significant coronary artery disease with a CAD-RADS >2
Exclusion criteria
Exclusion criteria: - The subject is suffering from unstable angina pectoris. - The subject is suffering from decompensated congestive cardiac failure. - The subject is suffering from a known non-ischemic cardiomyopathy. - The subject has a history of PCI or coronary artery bypass grafting (CABG). - The subject has had pacemaker or internal defibrillator leads implanted. - The subject has a prosthetic heart valve. - There is a severe language barrier. - The subject participates in any other clinical trial that interferes with the current study. - Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures. - The subject is or might be pregnant. - The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including: • The subject is suffering from a cardiac rhythm other than sinus rhythm. • The subject is morbidly obese (Body Mass Index (BMI) > 40). • 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 has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) < 45 ml/min/1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR < 60 ml/min/1,73m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of major adverse cardiovasculare events (MACE) - all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization - in a 12 month follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness Quality of life Avoided coronary angiographies Avoided invasive FFR-measurements | — |
Contacts
Public ContactLeonie Becker
St. Antonius Hospital
Outcome results
None listed