Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment825 (estimated)
SponsorSt. Antonius Hospital
Academic / other
Locations4 sites (Eindhoven, North Brabant and 3 other locations)
StatusRecruiting
StartedMarch 22, 2022
Main results expectedApril 1, 2025
Study endsApril 1, 2025
Registry record updatedDecember 2, 2024
Trial IDNCT04939207 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.