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Cardiac Imaging TechniquesNCT06804278

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

An observational study of Cardiac Imaging Techniques and Cardiac Imaging, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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"… Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 siteItaly
Study dates
18 Nov 2024to Feb 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vincenzo Russo, MD contact

+390512144747

vincenzo.russo@aosp.bo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Vincenzo Russo, MD, +390512144747, vincenzo.russo@aosp.bo.it

    Recruiting

Other trials in Italy

About this study

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).

Read the 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.

Medical subject headings
Cardiomyopathies, MINOCA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of myocarditis or MINOCA diagnosed with Spectral CT

    Diagnosis of the presence of myocarditis/MINOCA will be assessed.

    Measured: 1 week after examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start18 Nov 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804278
Sponsor's protocol ID
MioSpectralCT
Status last verified
Nov 2024
First submitted
9 Jan 2025
Last updated
3 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Imaging Techniques and Cardiac Imaging, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Vincenzo Russo, MD (+390512144747, vincenzo.russo@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of myocarditis or MINOCA diagnosed with Spectral CT (time frame: 1 week after examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Feb 2025.

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