Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.
Most patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan.
Subjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period.
The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.
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 will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row 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 PCI or CABG.
Parallel
CT-FFR
Diagnostic testCT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree
Angiography-derived FFR
Diagnostic testFFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries
Angiography with invasive FFR-measurements
Diagnostic testduring coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery.
Safety of non-invasive imaging techniques
The number of Major adverse cardiovasculare events (MACE) as 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.
Cost-effectiveness
Calculated using the total costs of the initial diagnostic tests, any additional tests or treatments for coronary artery disease, hospital admissions for suspected cardiac events and other costs that can be attributed to possible coronary artery disease. The medical costs will be calculated by the use of imta Medical Cost Questionnaire (iMCQ). Cost-effectiveness will be calculated by combining the total costs with the productivity loss using the iMTA Productivity Cost Questionnaire (iPCQ)
Seattle Angina Pectoris Questionnaire
This questionnaire focuses on the presence of and limits caused by angina pectoris symptoms
PHQ-9 Questionnaire
The Patient Health Questionnaire focuses on the mental health of the subject
PROMIS-10 Questionnaire
This questionnaire focuses on the overall health care consumption of the subject
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
UMC Utrecht
Collaborator
