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.
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
- Conditions the study is for
- Cardiac Imaging Techniques, Cardiac Imaging, Myocardial Disease
- 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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Vincenzo Russo, MD, +390512144747, vincenzo.russo@aosp.bo.it
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.
- Conditions
- Cardiac Imaging Techniques, Cardiac Imaging, Myocardial Disease, Myocarditis Acute, Minoca
- Medical subject headings
- Cardiomyopathies, MINOCA
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted3 Feb 2025
- Study start18 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Imaging TechniquesStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Russo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Spectral CT in the Diagnosis of Myocarditis/MINOCA in Patients Undergoing cardioCT Investigations for Acute Chest Pain
- ClinicalTrials.gov ID
- NCT06804278
- Acronym / sponsor ID
- MioSpectralCT
- Conditions
- Cardiac Imaging Techniques, Cardiac Imaging, Myocardial Disease, Myocarditis Acute, Minoca
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Feb 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.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 myocarditis or MINOCA diagnosed with Spectral CT
Time frame: 1 week after examination
Diagnosis of the presence of myocarditis/MINOCA will be assessed.
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 3 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiac Imaging Techniques
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
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.
Vincenzo Russo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
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.