Skip to main content
Clinical Trials/NCT06029400
NCT06029400
Recruiting
Not Applicable

CT-based Myocardial Characterization

IRCCS San Raffaele1 site in 1 country2,200 target enrollmentOctober 12, 2020

Overview

Phase
Not Applicable
Intervention
Retrospective cohort
Conditions
Not specified
Sponsor
IRCCS San Raffaele
Enrollment
2200
Locations
1
Primary Endpoint
Composite outcome
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2020
End Date
October 12, 2032
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antonio Esposito

Professor

IRCCS San Raffaele

Eligibility Criteria

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)

Arms & Interventions

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.

Outcomes

Primary Outcomes

Composite outcome

Time Frame: 60 months

first hospitalization for heart failure (HHF) or death (all-cause mortality).

Study Sites (1)

Loading locations...

Similar Trials