Photon Counting Computed Tomography in Heart Failure Patients (PCCT-HF)

May 6, 2025 updated by: Marina Pieri, Università Vita-Salute San Raffaele

Advanced Imaging With Photon Counting Computed Tomography in Heart Failure Patients: a Prospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Antonio Esposito, Professor
  • Phone Number: 02 2643 6102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with myocardial late contrast enhancement (LCE) areas
Time Frame: periprocedural
periprocedural
Identification of myocardial LCE patterns
Time Frame: periprocedural
LCE patterns: endocardial, mesocardial, epicardial, transmural.
periprocedural
Quantification of myocardial extracellular volume (ECV) fraction.
Time Frame: periprocedural
Percentage of ECV
periprocedural
The potential of PCCT in defining the etiology of heart failure
Time Frame: periprocedural
Identification of correlation of tissue features at imaging with different diseases causing heart failure
periprocedural

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a PCCT detected source of infection
Time Frame: periprocedural
periprocedural
Number of patients with a PCCT detected MCS device thrombosis
Time Frame: periprocedural
periprocedural

Other Outcome Measures

Outcome Measure
Time Frame
Residual left ventricle ejection fraction
Time Frame: periprocedural
periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Collaborators

Dr Anna Mara Scandroglio
Prof Antonio Esposito
Prof Anna Palmisano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

May 6, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCCT-HF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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