Evaluating new imaging techniques for coronary artery disease diagnosis
Official title: Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis
Run by St. Antonius Hospital · NCT04939207 · Data updated 2026-11-12
This study is testing new imaging methods to see if they can safely and effectively diagnose coronary artery disease without needing invasive procedures for patients who might have it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 825 (estimated) |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 4 sites (Eindhoven, North Brabant and 3 other locations) |
| Status | Recruiting |
| Started | March 22, 2022 |
| Main results expected | April 1, 2025 |
| Study ends | April 1, 2025 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT04939207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with suspected coronary artery disease presenting symptoms like recurrent angina pectoris.
✕Probably not a fit
Patients with unstable angina, decompensated heart failure, or a history of certain cardiac interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and cost-effectiveness of new imaging techniques for patients suspected of having coronary artery disease (CAD). It focuses on reducing unnecessary invasive cardiac angiography by utilizing non-invasive imaging tests, such as coronary CT scans, to evaluate blood flow restrictions. The study will compare traditional methods with innovative approaches that derive functional information from CT or angiographic images. By identifying patients who do not require treatment, the study seeks to optimize diagnostic pathways and improve patient care.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and less invasive diagnostic methods for coronary artery disease, reducing unnecessary procedures and associated risks.
How similar studies have gone: Previous observational studies have shown promise for similar imaging techniques, but this approach aims to establish a more standardized diagnostic pathway.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Catharina Hospital
Eindhoven, North Brabant, Netherlands Recruiting -
Maasstad Hospital
Rotterdam, South Holland, Netherlands Recruiting -
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands Recruiting -
UMC Utrecht
Utrecht, Utrecht, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Martin J Swaans, Dr. — St. Antonius Ziekenhuis Nieuwegein
- Study coordinator: Martin J Swaans, Dr.
- Email: m.swaans@antoniusziekenhuis.nl
- Phone: +31 (0)88 320 0900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.