Photon Counting Computed Tomography in Heart Failure Patients

NCT06964672 | Not Yet Recruiting

• 1 other identifier: PCCT-HF
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with severe acute or chronic heart failure are increasing worldwide. Heart failure clinicians are faced daily with the need to set up short- and long- term therapeutic strategies in line with heart failure etiology and myocardial recovery chances of each patient. Current treatment strategies for severe heart failure also include mechanical circulatory support with artificial devices (such as intraaortic balloon pump, Impella, ECMO, durable left ventricular assist device), which poses specific challenges for cardiac imaging. Through its ability to directly visualize scar and evaluate its transmural extent, cardiac magnetic resonance (CMR) offers a unique advantage over other currently available imaging techniques as a central player in viability assessment in patients with coronary disease, and represents the first line technique to investigate the chances of myocardial function recovery. CMR is also an important tool to provide diagnostic data in patients with non-ischemic heart failure. Unfortunately, CMR is not feasible in many heart failure patients (for example those on MCS therapy) due to the metallic components of the mechanical devices. In these patients, the computed tomography (CT) is the alternative imaging technique to visualize cardiac structures, diagnose complications, and assess possible indications for surgical interventions. However, CT has poorer resolution and do not offer the possibility to evaluate myocardial viability in patients with contraindication to CMR. Therefore, this issue currently represents one of the major unmet needs in the clinical management of severe heart failure patients. Recent technological advances in the field of CT imaging have nevertheless paved the way to explore new pathways of myocardial viability assessment even in patients traditionally deemed unsuitable for CMR. The introduction of photon-counting detectors, in particular, is expected to be the next major breakthrough in clinical x-ray computed tomography (CT). Photon-counting detector (PCD)-CT will overcome several shortcomings and limitations of current CT systems: it might substantially improve and expand the applicability of CT imaging by offering intrinsic spectral capabilities, increased spatial resolution, reduced electronic noise and improved image contrast. On the basis of this physical principle PCCT has the promise to improve the actual not fully satisfactory quality of scar visualization in CT images. In particular, conventional scanners are affected by a limited contrast resolution which lead to a variable and relevant rate of false negative myocardial scar-free images depending on the assessor expertise. The constant improving of CT diagnostic field have been revolutionizing the diagnostic workflow in several cardiac disease. Late contrast enhancement CT demonstrated an adequate accuracy to detect and discriminate the etiology of both ischemic and non-ischemic causes of myocardial injury compared to actual gold standard exams in patients with a troponin-positive acute chest pain syndrome. The same technique showed good sensitivity, specificity and a high negative predictive value (95%) for the identification of myocardial scars imputed to be an anatomical substrate of ventricular tachycardia with a proper concordance with electro-anatomic mapping findings (k=0.536). Finally, this enormous potential of CT implementation with the novel PCCT will provide not only the possibility to further study myocardial viability, but also is expected to be superior to standard CT exams in details definition, reduction of electronic noise and increase of spatial resolution, with consequent specific advantages in patients with heart failure, especially those with artificial devices with metallic components, in which adverse event identification and definition (such as inflow or outflow thrombosis) is complex. Thanks to these multiple diagnostic and therapeutic advantages, in combination with the availability of the PCCT device, the use of such technique is now the preferred cardiac imaging examination for the study of cardiac anatomy and function in patients with severe heart failure and a contraindication to perform the gold standard CMR. Thus, we planned a single-center observational study to asses the performance of PCCT in the identification of myocardial scars and patterns in critically ill patients with severe heart failure.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• Number of patients with myocardial late contrast enhancement (LCE) areas

  periprocedural

• Identification of myocardial LCE patterns

  LCE patterns: endocardial, mesocardial, epicardial, transmural.

  periprocedural

• Quantification of myocardial extracellular volume (ECV) fraction.

  Percentage of ECV

  periprocedural

• The potential of PCCT in defining the etiology of heart failure

  Identification of correlation of tissue features at imaging with different diseases causing heart failure

  periprocedural

Secondary Outcomes (2)

• Number of patients with a PCCT detected source of infection

  periprocedural

• Number of patients with a PCCT detected MCS device thrombosis

  periprocedural

Other Outcomes (1)

• Residual left ventricle ejection fraction

  periprocedural

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with acute or chronic heart failure undergoing PCCT will be included in the study, upon signature of informed consent.

You may qualify if:

• Presence of acute or chronic heart failure
• Clinical need for a CT exam with angiographic evaluation and scar imaging
• Contraindication to perform a Magnetic Resonance Imaging.
• All ages
• Signature of Informed Consent

You may not qualify if:

• Absence of acute or chronic heart failure
• Absence of clinical indication to a CT exam
• Contraindication to perform a CT exam.
• Pregnancy
• Refusal to provide Informed Consent to participate to the study

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• Dr Anna Mara Scandroglio: collaborator
• Prof Antonio Esposito: collaborator
• Prof Anna Palmisano: collaborator

Related Publications (12)

• Pieri M, Ortalda A, Altizio S, Bertoglio L, Nardelli P, Fominskiy E, Lapenna E, Ajello S, Scandroglio AM. Prolonged Impella 5.0/5.5 support within different pathways of care for cardiogenic shock: the experience of a referral center. Front Cardiovasc Med. 2024 Jul 2;11:1379199. doi: 10.3389/fcvm.2024.1379199. eCollection 2024.

  PMID: 39015682 BACKGROUND

• Barac YD, Nevo A, Schroder JN, Milano CA, Daneshmand MA. LVAD Outflow Graft Role in Pump Thrombosis. ASAIO J. 2020 Feb;66(2):128-131. doi: 10.1097/MAT.0000000000000936.

  PMID: 30585873 BACKGROUND

• Ajello S, Pieri M, Bertoglio L, Altizio S, Nardelli P, Scandroglio AM. Extrinsic outflow graft flow obstruction in patients with HeartMate3 LVAD. Artif Organs. 2023 Apr;47(4):786-790. doi: 10.1111/aor.14450. Epub 2022 Nov 17.

  PMID: 36385253 BACKGROUND

• Esposito A, Palmisano A, Antunes S, Maccabelli G, Colantoni C, Rancoita PMV, Baratto F, Di Serio C, Rizzo G, De Cobelli F, Della Bella P, Del Maschio A. Cardiac CT With Delayed Enhancement in the Characterization of Ventricular Tachycardia Structural Substrate: Relationship Between CT-Segmented Scar and Electro-Anatomic Mapping. JACC Cardiovasc Imaging. 2016 Jul;9(7):822-832. doi: 10.1016/j.jcmg.2015.10.024. Epub 2016 Feb 17.

  PMID: 26897692 BACKGROUND

• Palmisano A, Vignale D, Tadic M, Moroni F, De Stefano D, Gatti M, Boccia E, Faletti R, Oppizzi M, Peretto G, Slavich M, Sala S, Montorfano M, Agricola E, Margonato A, De Cobelli F, Gentile F, Robella M, Cortese G, Esposito A. Myocardial Late Contrast Enhancement CT in Troponin-Positive Acute Chest Pain Syndrome. Radiology. 2022 Mar;302(3):545-553. doi: 10.1148/radiol.211288. Epub 2021 Dec 7.

  PMID: 34874200 BACKGROUND

• Palmisano A, Vignale D, Benedetti G, Del Maschio A, De Cobelli F, Esposito A. Late iodine enhancement cardiac computed tomography for detection of myocardial scars: impact of experience in the clinical practice. Radiol Med. 2020 Feb;125(2):128-136. doi: 10.1007/s11547-019-01108-7. Epub 2019 Nov 29.

  PMID: 31784926 BACKGROUND

• Sartoretti T, Wildberger JE, Flohr T, Alkadhi H. Photon-counting detector CT: early clinical experience review. Br J Radiol. 2023 Jul;96(1147):20220544. doi: 10.1259/bjr.20220544. Epub 2023 Feb 10.

  PMID: 36744809 BACKGROUND

• Danielsson M, Persson M, Sjolin M. Photon-counting x-ray detectors for CT. Phys Med Biol. 2021 Jan 29;66(3):03TR01. doi: 10.1088/1361-6560/abc5a5.

  PMID: 33113525 BACKGROUND

• Bock A, Estep JD. Myocardial viability: heart failure perspective. Curr Opin Cardiol. 2019 Sep;34(5):459-465. doi: 10.1097/HCO.0000000000000651.

  PMID: 31233411 BACKGROUND

• Patel AR, Salerno M, Kwong RY, Singh A, Heydari B, Kramer CM. Stress Cardiac Magnetic Resonance Myocardial Perfusion Imaging: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Oct 19;78(16):1655-1668. doi: 10.1016/j.jacc.2021.08.022.

  PMID: 34649703 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

• Al-Sabeq B, Nabi F, Shah DJ. Assessment of myocardial viability by cardiac MRI. Curr Opin Cardiol. 2019 Sep;34(5):502-509. doi: 10.1097/HCO.0000000000000656.

  PMID: 31394561 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Anna Mara Scandroglio, MD

CONTACT

+39 0226437722; scandroglio.mara@hsr.it

Antonio Esposito, Professor

CONTACT

02 2643 6102

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 9, 2025

Record last verified: 2025-05