Heart FailurePCCT-HFNCT06964672
Photon Counting Computed Tomography in Heart Failure Patients
An observational study of Heart Failure, run by Università Vita-Salute San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with acute or chronic heart failure undergoing PCCT will be included in the study, upon signature of informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Antonio Esposito, Professor contact
About this study
Official title: 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with myocardial late contrast enhancement (LCE) areas
Measured: periprocedural
Identification of myocardial LCE patterns
LCE patterns: endocardial, mesocardial, epicardial, transmural.
Measured: periprocedural
Quantification of myocardial extracellular volume (ECV) fraction.
Percentage of ECV
Measured: 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
Measured: periprocedural
Secondary outcomes (2)
Number of patients with a PCCT detected source of infection
Measured: periprocedural
Number of patients with a PCCT detected MCS device thrombosis
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Anna Mara Scandroglio, Prof Antonio Esposito, Prof Anna Palmisano
- Responsible party
- Principal investigator, Marina Pieri, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964672
- Sponsor's protocol ID
- PCCT-HF
- Acronym
- PCCT-HF
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39015682Barac 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.
PubMed 30585873Ajello 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.
PubMed 36385253Esposito 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.
PubMed 26897692Palmisano 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.
PubMed 34874200Palmisano 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.
PubMed 31784926Sartoretti 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.
PubMed 36744809Danielsson 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.
PubMed 33113525Bock A, Estep JD. Myocardial viability: heart failure perspective. Curr Opin Cardiol. 2019 Sep;34(5):459-465. doi: 10.1097/HCO.0000000000000651.
PubMed 31233411Patel 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.
PubMed 34649703McDonagh 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.
PubMed 34447992Al-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.
PubMed 31394561
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging With Photon Counting Computed Tomography in Heart Failure Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT06964672
- Acronym / sponsor ID
- PCCT-HF / PCCT-HF
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Dr Anna Mara Scandroglio, Prof Antonio Esposito, Prof Anna Palmisano
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with acute or chronic heart failure undergoing PCCT will be included in the study, upon signature of informed consent.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with myocardial late contrast enhancement (LCE) areas
Time frame: periprocedural
Identification of myocardial LCE patterns
Time frame: periprocedural
LCE patterns: endocardial, mesocardial, epicardial, transmural.
Quantification of myocardial extracellular volume (ECV) fraction.
Time frame: periprocedural
Percentage of ECV
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
2 secondary outcomes
Number of patients with a PCCT detected source of infection
Time frame: periprocedural
Number of patients with a PCCT detected MCS device thrombosis
Time frame: periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 39015682Pieri 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.
- Background: PubMed 30585873Barac 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.
- Background: PubMed 36385253Ajello 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.
- Background: PubMed 26897692Esposito 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.
- Background: PubMed 34874200Palmisano 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.
- Background: PubMed 31784926Palmisano 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.
- Background: PubMed 36744809Sartoretti 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.
- Background: PubMed 33113525Danielsson 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.
- Background: PubMed 31233411Bock A, Estep JD. Myocardial viability: heart failure perspective. Curr Opin Cardiol. 2019 Sep;34(5):459-465. doi: 10.1097/HCO.0000000000000651.
- Background: PubMed 34649703Patel 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.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 31394561Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Esposito, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Università Vita-Salute San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Mara Scandroglio, MD (+39 0226437722, scandroglio.mara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with myocardial late contrast enhancement (LCE) areas (time frame: periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964672, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.