Stable coronary artery disease - stable angina pectoris
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
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 is clinically suspected 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 or agrees to undergo coronary CTA with >=64 multidetector row coronary CTA.
Exclusion criteria
Exclusion criteria: • The subject has at least one coronary stenosis of >=90% diameter reduction as seen on coronary CTA • 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 percutaneous coronary intervention or coronary artery bypass grafting. • The subject has 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. • The subject*s 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 SCCT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is a composite of MACE (all-cause mortality, aborted sudden cardiac death, myocardial infarction, and unplanned hospitalization for chest pain leading to urgent revascularization) at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints consist of the diagnostic performance of the alternative methods combined with a combined endpoint of hospitalization for unstable angina pectoris or other cardiac causes and the cost-effectiveness. Formal cost-effectiveness- and budget impact (BIA) analyses will be performed for both FFR-CT and QFR. Cost-effectiveness and acceptability curves will be made. The BIA comprises the budgetary framework for health care (net-BKZ) perspective and the perspective of the health insurer. | — |
Countries
Netherlands
Outcome results
None listed