Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina

NCT07864025 — Recruiting, 70 participants, Queen Mary University of London

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Next Generation Coronary Plaque Characterisation and Computation of Flow Patterns: Photon-Counting Computed Tomography Coronary Angiography Versus State-of-the-Art Multimodality Intravascular Imaging

RegistryNCT07864025, acronym ILUMINA
StatusRecruiting
Study typeObservational
Enrollment70 (Estimated)
SponsorQueen Mary University of London (Other)
ConditionsCoronary Artery Disease (CAD), Stable Angina Pectoris, Ischaemic Heart Disease (IHD)
Interventionsobservational study (Other)
Datesstart 2026-08-19, primary completion 2029-04-03 (estimated), completion 2029-04-03 (estimated), first posted 2026-10-07, last updated 2026-10-07
Locations1 site in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease (CAD) All trials for Stable Angina Pectoris All trials of observational study

-Summary

Coronary artery disease, caused by the furring up of the heart arteries by atherosclerosis, is a major cause of death in the UK. Despite existing therapies, adverse cardiovascular events remains high, especially in patients who have already had a heart attack, as some of these patients have aggressive atherosclerotic disease. If we could identify these vulnerable patients, then in wider clinical practice in the future we might be able to treat them better with new therapies that can otherwise be expensive or come with a risk of side-effects. Traditionally, the assessment of atherosclerotic disease and the identification of the plaques that will cause heart attacks is performed using invasive imaging - imaging taken by passing a wire into the arteries of the heart that has a camera on its tip. Invasive imaging, however, can be used only in patients with symptoms and has risks. Photon counting (PC) CT is a new CT system that has image quality comparable to invasive imaging and can be used in the community to examine individuals with stable angina symptoms. In this study we aim to compare how well PC-CT detects high-risk plaques compared with invasive imaging and in due course develop a platform that will expedite the analysis of CT images to allow its broad use in the clinical practice.

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+Arms and interventions

ArmTypeInterventionsDescription
Patients with Chronic Coronary SyndromeOther: observational study
  • observational study (Other): Observation study comparing Photon-counting CT with intravascular coronary imaging in patients with chronic coronary syndrome

+Outcome measures

Primary outcomes

  • Compare the efficacy of PC-CTA and of conventional CTA in assessing the percent atheroma volume (PAV) using the output of the NIRS-IVUS analysis as the reference standard [After each patient has had coronary angiography]

Secondary outcomes

  • Identify the optimal reconstruction method of PC-CTA data for measuring the PAV in the studied segment using the NIRS-IVUS estimations as the reference standard. [After each patient has had coronary angiography.]
  • Compare the accuracy of PC-CTA and conventional CTA in measuring flow patterns. [After each patient has had coronary angiography.]

+Eligibility

Sex: All, ages: 18 Years to 79 Years

Inclusion Criteria:

* Able and willing to give informed consent
* Between ages 18-79
* Patients with a stable coronary syndrome that had recent PC-CTA showing at least one lesion requiring further evaluation with intravascular imaging or fractional flow reserve and is considered suitable for PCI under IVUS guidance

Exclusion Criteria:

* Unable to or unwilling to give informed consent
* Age >80 years
* Recent acute coronary syndrome within < 3 months
* Renal failure (eGFR <60ml/min/1.73m²)
* History of previous coronary artery bypass surgery
* Decompensated heart failure, or left ventricular ejection fraction ≤30%
* Previous heart transplantation
* Intravenous contrast allergy
* Unable to receive treatment with aspirin, heparin, or thienopyridines
* Anticipated life expectancy <1 year
* Pregnancy
* Patient that requires surgical revascularisation
* Extensive coronary artery disease (i.e. multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the coronary arteries with NIRS-IVUS imaging

+Locations (1)

FacilityCityCountryStatus
William Harvey Research Institute, Barts and The London, Queen Mary University of LondonLondonUnited KingdomRecruiting

+Publications

  • Sakai K, Shin D, Singh M, Malik S, Dakroub A, Sami Z, Weber J, Cao JJ, Parikh R, Chen L, Sosa F, Cohen DJ, Moses JW, Shlofmitz RA, Collet C, Shlofmitz E, Jeremias A, Khalique OK, Ali ZA. Diagnostic Performance and Clinical Impact of Photon-Counting Detector Computed Tomography in Coronary Artery Disease. J Am Coll Cardiol. 2025 Feb 4;85(4):339-348. doi: 10.1016/j.jacc.2024.10.069. Epub 2024 Oct 28. PMID 39466216
  • Ramasamy A, Hamid A Khan A, Cooper J, Simon J, Maurovich-Horvat P, Bajaj R, Kitslaar P, Amersey R, Jain A, Deaner A, Reiber JH, Moon JC, Dijkstra J, Serruys PW, Mathur A, Baumbach A, Torii R, Pugliese F, Bourantas CV. Implications of computed tomography reconstruction algorithms on coronary atheroma quantification: Comparison with intravascular ultrasound. J Cardiovasc Comput Tomogr. 2023 Jan-Feb;17(1):43-51. doi: 10.1016/j.jcct.2022.09.004. Epub 2022 Sep 21. PMID 36270952
  • Ramasamy A, Parasa R, Sokooti H, Zhang X, Tanboga IH, Kitslaar P, Broersen A, Rathod KS, Amersey R, Jain A, Ozkor M, Reiber JHC, Dijkstra J, Serruys PW, Moon JC, Mathur A, Torii R, Pugliese F, Baumbach A, Bourantas CV. Computed tomography versus near-infrared spectroscopy for the assessment of coronary atherosclerosis. EuroIntervention. 2024 Dec 2;20(23):e1465-e1475. doi: 10.4244/EIJ-D-24-00096. PMID 39618266
  • Ramasamy A, Pugliese F, Tanboga IH, Kitslaar P, Dijkstra J, Mathur A, Torii R, Moon JC, Baumbach A, Bourantas CV. Head-to-Head Comparison of Near-Infrared Spectroscopy-Intravascular Ultrasound and Coronary Computed Tomography Angiography in Assessing Atheroma Characteristics. JACC Cardiovasc Imaging. 2024 Dec;17(12):1507-1510. doi: 10.1016/j.jcmg.2024.07.005. Epub 2024 Sep 11. No abstract available. PMID 39269412

+Investigators