Role of Spectral CT in the Diagnosis of Myocarditis/MINOCA in Patients Undergoing cardioCT Investigations for Acute Chest Pain

It is a spontaneous, observational cross-sectional and single-center imaging (CT and MRI) study, coupled with clinical-laboratory data. Patients with acute chest pain with low/intermediate probability of coronary artery disease, ECG and/or troponin not diagnostic or altered according to the current "standards of care" used in the ED/Department (ESC Guidelines 2020), will be enrolled consecutively and will undergo CT examinations by means of "Spectral" CT technology. CT investigation will allow to identify any non-myocarditis causes of acute chest pain and by means of spectral analysis of CT images it will try to identify signs suggestive of damage myocardial (such as ECV, LIE, hyperemia and edema).

Study Overview

• Status: Recruiting
• Conditions: Myocarditis Acute; Cardiac Imaging Techniques; Myocardial Disease; Cardiac Imaging; Minoca

Detailed Description

Innovation in the field of CT (Computed Tomography) with the introduction of new technologies, including the detector-based SpectralCT or Spectral CT (SDCT), has led in recent years to a true "paradigm-shift" from an evaluation of CT images on a purely "observational" to the "radiomics" level, allowing the introduction of additional valuable quantitative information, obtained only through post-processing with software CT images. In particular, Spectral CT is a scanner dedicated to tissue characterization thanks to its ability to "break down" and separate the different materials that make up fabrics, creating sets of monoenergetic (different KeV) or selective (water, iodine, etc.) images.

With this method, it is therefore possible to obtain information previously obtainable with conventional CT equipment, such as iodine maps, medium subtraction tissue characterization data through the calculation of extracellular volume (ECV), the visualization of hyperemia, edema and much more. It is precisely the ability to characterize myocardial tissue, in particular to highlight edema or a fibrotic replacement by ECV calculation and late iodine enhancement (LIE), is one of the most interesting aspects of this new method in the field of imaging cardiovascular, for example in the urgent/emergency setting, where radiology plays a key role in the evaluation of the main causes of acute chest pain, such as heart attack, pulmonary embolism, acute aortic syndromes and myocarditis.

In particular, CT is the first-line method in patients with acute chest pain with low/intermediate probability of coronary artery disease, ECG and/or non-diagnostic troponin(s) or and has already demonstrated its ability to simultaneously exclude disease coronary artery, pulmonary embolism, and aortic dissection through a single examination commonly called "Triple rule out".

To date, however, the non-invasive diagnosis of myocarditis/MINOCA (Myocardial Infarction at coronary arteries) is not obtainable from the evaluation of conventional CT images and is prerogative of cardiac magnetic resonance imaging (MRI) [3]. The added value of the "Spectral CT", thanks to the characteristics described above, could be that of highlighting and/or excluding, in addition to the three aforementioned causes of acute chest pain (i.e. heart attack, pulmonary embolism and acute aortic syndrome), also acute myocarditis or MINOCA The new technology on which SpectralCT is based could in fact make it possible to highlight signs suggestive of myocardial damage, such as ECV, LIE, hyperemia and edema, by post-processing of the same CT images acquired in usual clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Vincenzo Russo, MD; Phone Number: +390512144747; Email: vincenzo.russo@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Vincenzo Russo, MD; Phone Number: +390512144747; Email: vincenzo.russo@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients from ED or the other wards of the IRCCS University Hospital of Bologna (department of Cardiology Intensive Care, Cardiology Unit), with acute chest pain and low/intermediate probability of coronary artery disease, ECG and/or troponin not diagnostic or altered, which will be subjected to cardiac CT examinations using "Spectral" technology and possibly MRI examinations by the cardioradiology team of the Radiology Unit, IRCCS University Hospital of Bologna.

Description

Inclusion Criteria:

• Age greater than or equal to 18 years;
• patients with acute chest pain and indication for triple-rule-out CT or coronary CT examination, i.e. low/intermediate probability of acute coronary artery disease, ECG and/or troponin not diagnostic or altered;
• Obtaining informed consent

Exclusion Criteria:

• Absolute contraindications to CT examination and/or iodinated mdc administration (i.e. pregnancy, severe renal impairment in non-dialysis patients with GFR < 15-30 ml/min/1.73m2 );
• CT examinations that do not allow diagnostic information to be provided because they are assessed as quality too scarce and not interpretable (affected by artifacts such as motion artifacts)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of myocarditis or MINOCA diagnosed with Spectral CT	Diagnosis of the presence of myocarditis/MINOCA will be assessed.	1 week after examination

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Vincenzo Russo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; MINOCA; Myocarditis; Cardiomyopathies; Chest Pain
• Other Study ID Numbers: MioSpectralCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No