Evaluating new imaging techniques for coronary artery disease diagnosis

Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis

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

• Phase: NA
• Study type: Interventional
• Enrollment: 825 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Antonius Hospital (other)
• Locations: 4 sites (Eindhoven, North Brabant and 3 other locations)
• Trial ID: NCT04939207 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with suspected coronary artery disease presenting symptoms like recurrent angina pectoris.

Not a fit: Patients with unstable angina, decompensated heart failure, or a history of certain cardiac interventions may not benefit from this study.

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 performed: Previous observational studies have shown promise for similar imaging techniques, but this approach aims to establish a more standardized diagnostic pathway.

Eligibility 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 this trial is running

Eindhoven, North Brabant and 3 other locations

• 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.

Conditions: Coronary Artery Disease, Coronary artery disease, Angina pectoris, Coronary arteriosclerosis, CT scan, Cardiac catheterization, Coronary angiography, Myocardial fractional flow reserve