CT-based Myocardial Characterization (CTMyoC)

NCT ID: NCT06029400

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-12

Study Completion Date

2032-10-12

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Antonio Esposito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Esposito

Role: CONTACT

02 2643 6102

Anna Palmisano

Role: CONTACT

Facility Contacts

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Antonio Esposito

Role: primary

02 2643 6102

References

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Other Identifiers

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CTMyoC

Identifier Type: -

Identifier Source: org_study_id

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