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

NCT06804278 | Recruiting

• 1 other identifier: MioSpectralCT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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" 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).

Conditions

Cardiac Imaging Techniques; Cardiac Imaging; Myocardial Disease; Myocarditis Acute; Minoca

Outcome Measures

Primary Outcomes (1)

• number of myocarditis or MINOCA diagnosed with Spectral CT

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

  1 week after examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies; MINOCA

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Vincenzo Russo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Russo, MD

CONTACT

+390512144747; vincenzo.russo@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 3, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)