Improving the Cost-effectiveness Of Coronary Artery Disease Diagnosis
- Conditions
- Stable coronary artery disease - stable angina pectoris10011082
- Registration Number
- NL-OMON51987
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3300
• 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.
• 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint is a composite of MACE (all-cause mortality, aborted sudden<br /><br>cardiac death, myocardial infarction, and unplanned hospitalization for chest<br /><br>pain leading to urgent revascularization) at 1 year.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints consist of the diagnostic performance of the alternative<br /><br>methods combined with a combined endpoint of hospitalization for unstable<br /><br>angina pectoris or other cardiac causes and the cost-effectiveness. Formal<br /><br>cost-effectiveness- and budget impact (BIA) analyses will be performed for both<br /><br>FFR-CT and QFR. Cost-effectiveness and acceptability curves will be made. The<br /><br>BIA comprises the budgetary framework for health care (net-BKZ) perspective and<br /><br>the perspective of the health insurer.</p><br>