CT-based Myocardial Characterization (CTMyoC) (CTMyoC)

January 14, 2026 updated by: Antonio Esposito, IRCCS San Raffaele

CT-based Myocardial Characterization

The identification of myocardial fibrosis in term of myocardial scar and extracellular matrix remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy and to be prognosticators of major cardiovascular adverse events [1-14].

For these reason CMR represent the gold standard for the non-invasive characterization of myocardial tissue in the clinical practice.

However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac devices, and in case of conditional device they may also significantly impair LGE assessability due to artefacts [19]); 2) has limited availability and it is time consuming, therefore it is difficult to perform in the acute setting also because of poor patient compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not assessable with CMR. Moreover the recent technological advancement has continuously increased the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs.

cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar and extracellular volume fraction, with the advantage of a single shot evaluation of coronary arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In particular, several studies including some from our group, have demonstrated the clinical utility of myocardial tissue characterization with cCT in different clinical settings, such as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23], heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the interesting results, all these previous studies are limited on highly selected and small sample size. Moreover, any large study with long term follow-up is available in the setting of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain and texture) and no data are available about its prognostic impact. Aim of the study is to evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and associate to other CT imaging biomarker on a large population of patient clinically candidate to cardiac CT.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a monocentric observational study with a retrospective and a prospective arms.

Patients will be recruited from the Radiology Department of our Institution (IRCCS Ospedale San Raffaele, Milan, Italy). Written informed consent will be obtained.

Description

Inclusion Criteria:

  • age ≥ 18 years;
  • no contraindication to cCT
  • signed informed consent
  • clinical indication to cCT for the following reason: stable angina, heart failure, atrial/ ventricular arrhythmias, acute chest pain with need of "triple-rule-out" scan, planning of valvular repair/substitution, structural and infiltrative cardiomyopathy, new onset ECG alteration, troponin increase.

Exclusion Criteria:

  • age < 18 years
  • pregnancy and/or breastfeeding
  • contraindications to iodinated contrast agent administration or impaired renal function (eGFR ≤ 30 mL/min);
  • inability to sustain a brief breath hold (5 seconds)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Retrospective cohort
The retrospective arm of the study will include 200 patients meeting the inclusion criteria who have received a cardiac CT from January 2013 to date of approval amendment. (2013 was chosen as starting year to retrieve CT and clinical date in order to have at least 5 years of follow-up per patients).
Prospective cohort
The prospective arm of the study will include 2000 consecutive patients meeting the inclusion criteria, candidate to cardiac CT along the 7 years after date of approval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome
Time Frame: 60 months
first hospitalization for heart failure (HHF) or death (all-cause mortality).
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Estimated)

October 12, 2032

Study Completion (Estimated)

October 12, 2032

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMyoC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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