Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease (iCORONARY)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    825
  • sponsor
    St. Antonius Hospital
Updated on 5 June 2022
angiography
stenosis
angina pectoris
coronary ct

Summary

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.

Description

Only a small proportion of the 180 000 patients that are referred to a cardiologist each year in the Netherlands with complaints of angina pectoris or shortness of breath suffer from coronary stenosis in such a degree that revascularisation is required. To identify these patients, multiple diagnostic tests are available. Simple non-interventional imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out coronary artery disease. However, when coronary artery disease 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.

In retrospect, many patients unnecessarily undergo cardiac angiography with, if deemed neccessary, flow measurements. These patients do not need treatment for coronary artery disease. 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. These new imaging techniques have been tested extensively in observational studies. Currently, there is no consensus in the optimal diagnostic pathway resulting in major differences in strategies between hospitals. Moreover,data on cost-effectiveness is lacking.

This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan. Our target population will be patients with complaints of angina pectoris or shortness of breath for which the patients will undergo coronary CT-scan. If the CT-scan shows one or more possibly flow-limiting stenoses, further diagnostic testing is required. These subjects are randomized in one of three possible arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, subjects are treated according to routine care guidelines. Subjects are requested to complete 5 questionnaires in a 12 month follow-up period. The primary 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 during the 12-month follow-up period. Secondary endpoints consist of cost-effectiveness, the number of avoided invasive coronary angiographies and flow measurements and quality of life. The investigators will use hospital patient files and completed questionnaires to collect information about events during the follow-up period until the last included subject has completed their final questionnaire.

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.

In addition to the randomised controlled trial, all eligible subjects whose coronary CT-scan does not show possibly significant coronary artery disease (CAD-RADS 0-2) are included in a patient registry. Because of absent or limited coronary artery disease, additional diagnostic testing is not needed in these patients. These subjects are requested to answer 5 questionnaires in a 12-month period, similar to the subjects included in the RCT-part of the trial. The outcome measures of this part of the trial are similar to those of the RCT. Our primary outcome is the occurrence of MACE-events, secondary outcomes are quality of life and patient satisfaction.

Details
Condition Coronary Artery Disease
Treatment CT-FFR, Angiography-derived FFR, Angiography with invasive FFR-measurements
Clinical Study IdentifierNCT04939207
SponsorSt. Antonius Hospital
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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 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
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