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NCT04939207

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

Sponsor: St. Antonius Hospital

View on ClinicalTrials.gov

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.

Official title: Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

825

Start Date

2022-03-22

Completion Date

2025-04-01

Last Updated

2024-12-02

Healthy Volunteers

Conditions

Coronary Artery Disease

Interventions

DIAGNOSTIC_TEST

CT-FFR

CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree

DIAGNOSTIC_TEST

Angiography-derived FFR

FFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries

DIAGNOSTIC_TEST

Angiography with invasive FFR-measurements

during 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.

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.

Locations (4)

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Maasstad Hospital

Rotterdam, South Holland, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (4)