New heart scan could replace invasive artery probes
NCT ID NCT07472634
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new imaging platform called Cardiolens that uses CT scans to non-invasively diagnose significant blockages in heart arteries. Researchers compared its accuracy to standard invasive procedures in 150 patients with suspected chronic coronary syndrome. The goal was to see if this platform could reduce the need for invasive diagnostic tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could offer a non-invasive way to diagnose significant heart artery blockages, potentially reducing the number of invasive catheter procedures needed.
- What could go wrong
- This is a completed diagnostic accuracy study, not a treatment trial. The platform's real-world benefit depends on further validation and integration into routine care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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150 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Positive medical history suggestive of chronic coronary syndrome (CCS)
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Age 18-90 years. 2. Signed informed consent to participate in the study. 3. Positive medical history suggestive of chronic coronary syndrome (CCS). 4. Diagnostic CCTA performed no more than 122 days prior to the planned ICA, of sufficient quality to assess the entire coronary tree (both arteries reconstructable in a single series), demonstrating at least one ≥50% stenosis in an epicardial coronary artery \>2.0 mm in diameter, not previously revascularized. 5. Planned ICA with the intention to perform FFR measurement no later than 122 days after the CCTA. 6. Stable treatment for CCS without the need for dose adjustments for at least 30 days prior to study inclusion. Exclusion Criteria 1. Presence of myocardial bridging on CCTA causing \>50% systolic narrowing of an epicardial coronary artery, per Investigator's assessment. 2. Complications occurring during CCTA that reduce the safety or feasibility of CTP (per treating physician decision). 3. Stenosis of the left main coronary artery \>40%. 4. Myocardial infarction occurring between CCTA and ICA, documented by elevated cardiac biomarkers (troponin, myoglobin) or new wall motion abnormalities or new coronary occlusion. 5. History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the last 90 days. Not applicable to patients undergoing functional testing with regadenoson. 6. Atrioventricular block (type II-III), prolonged QT interval, or sick sinus syndrome. 7. Renal insufficiency (creatinine ≥1.6 and/or glomerular filtration rate \<30 ml/m²) or renal failure requiring dialysis. 8. Persistent atrial fibrillation. 9. BMI \>40. 10. Implanted pacemaker or internal cardioverter-defibrillator. 11. Pregnancy or inability to exclude pregnancy. 12. Hemodynamic instability per treating physician, including but not limited to: cardiogenic shock, hypotension (systolic blood pressure \<90 mmHg), treatment-resistant hypertension (systolic blood pressure \>180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medication. 13. Significant allergies or adverse reactions (per Investigator) to iodinated contrast agents, adenosine, regadenoson, or aminophylline. Contraindications include: anaphylactic shock, angioedema. 14. Significant valvular heart disease-at least moderate regurgitation or stenosis. 15. Structural heart disease, including post-corrective procedures. 16. Malignant coronary artery anomaly. 17. History of myocardial infarction. 18. Prior coronary artery bypass grafting (CABG). 19. Prior PCI if the target vessel for evaluation has previously undergone PCI. 20. Chronic total occlusion (CTO) of a coronary artery. 21. Left ventricular ejection fraction (LVEF) ≤35%. 22. Presence of conditions that, in the Investigator's opinion, may significantly change the patient's health status within 122 days. 23. Other relevant comorbidities, infections, addictions, or psychological or social factors that, in the Investigator's opinion, may impair participation in the study or significantly affect patient safety.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The 4th Military Teaching Hospital
Wroclaw, Poland
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The Cardinal Stefan Wyszyński National Institute of Cardiology
Warsaw, Poland
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The Jan Mikulicz-Radecki University Teaching Hospital
Wroclaw, Poland
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The John Paul II Specialist Hospital in Kraków
Krakow, Poland
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The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, Poland
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The University Clinical Centre
Gdansk, Poland
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University Hospital in Kraków
Krakow, Poland
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Świętokrzyskie Cardiology Center, Regional Combined Hospital in Kielce
Kielce, Poland
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