Myocardial Infarction Clinical Trial
— CT-STEMIOfficial title:
Cardiac Computed Tomography for Comprehensive Risk Stratification of Arrhythmic, Atherothrombotic and Heart Failure Events Following Reperfused ST-segment Elevation Myocardial Infarction
The CT-STEMI study aims to evaluate a comprehensive cardiac computed tomography (CCT) protocol for assessing the risk of heart failure (HF), life-threatening arrhythmias (LTA), and atherothrombotic events following ST-elevation myocardial infarction (STEMI). This multicenter, prospective study has three main objectives: 1. Comparing the diagnostic accuracy of the comprehensive CCT protocol with cardiac magnetic resonance (CMR), considered the non-invasive gold standard. 2. Determining the prognostic value of CCT in assessing myocardial tissue adverse features related to STEMI. 3. Evaluating the atherosclerotic burden in patients with post-acute STEMI. Two hundred patients will undergo both CCT and CMR in the post-acute phase, and their follow-up will focus on monitoring HF, LTA, and ischemic events. The CT-STEMI study represents the first attempt to assess the potential of CCT in providing a comprehensive risk assessment following STEMI in a large contemporary population. The findings of this study have the potential to revolutionize post-STEMI risk stratification practices.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent - STEMI diagnosis - Primary Percutaneous Coronary Intervention (PCI) <24h from symptom onset - Hemodynamic stability without inotropic support within 4 days from the index event Exclusion Criteria: - Known chronic kidney disease with estimated Glomerular Filtration Rate (GFR) < 30 mL/min/1.73mq - History of allergic reaction to CCT or CMR contrast media - Inability or unwilling to undergo CCT or CMR scanning - Pregnancy or breast-feeding - Severe atrial or ventricular arrhythmia burden - Severe valvular stenosis or regurgitation - Prior clinical congestive HF diagnosis (asymptomatic LV dysfunction can be included) |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Policlinico Universitario "G. Martino" | Messina | |
Italy | Istituto Auxologico Italiano - IRCCS - Ospedale San Luca | Milan | |
Italy | A.O.U. Città della Salute e della Scienza - Molinette Hospital | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy | A.O.U. Città della Salute e della Scienza - Molinette Hospital, Istituto Auxologico Italiano, Ministry of Health, Italy, University of Messina |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CCT - diagnostic accuracy | CMR study will be used as the reference standard to assess the accuracy of CCT in evaluating morpho-functional parameters such as
LVEDV (ml) LVESV (ml) LVEF (%) RVEDV (ml) RVESV (ml) RVEF (%) Additionally, the study will also examine myocardial tissue characteristics including: IS: presence or absence IS (gr) IS (% of the total left ventricular mass) Myocardial edema: presence or absence Myocardial edema (gr) Myocardial edema (% of the total left ventricular mass) MVO: presence or absence MVO (gr) MVO (% of the total left ventricular mass) IMH: presence or absence IMH (gr) IMH (% of the total left ventricular mass) ECV (%) |
Baseline | |
Primary | CCT - risk stratification | Individual CCT predictors will be evaluated and compared with those derived from CMR:
IS: presence or absence IS (gr) IS (% of the total left ventricular mass) Myocardial edema: presence or absence Myocardial edema (gr) Myocardial edema (% of the total left ventricular mass) MVO: presence or absence MVO (gr) MVO (% of the total left ventricular mass) IMH: presence or absence IMH (gr) IMH (% of the total left ventricular mass) ECV (%) |
1 month, 1 year | |
Primary | CCT - Coronary artery disease (CAD) impact of risk stratification | CCT Report include prevalence and features of non-culprit plaques with a qualitative analysis, based on the presence of:
positive remodeling: presence or absence low attenuation plaque: presence or absence spotty calcification: presence or absence "napkin ring" sign: presence or absence and semi-quantitative analysis with a dedicated cardiac CT software: Plaque burden (%) Plaque volume (per lesion and per vessel) (mm^3) Vessel remodeling index (ratio) Mean plaque and lumen intensities (HU) Plaque characterization components: presence or absence of Dense Calcium, Necrotic Core, Fibrous Fatty, Fibrous Evaluation of Peri Vascular Adipose Tissue (PVAT) - thickness measurement in millimeters (mm) Evaluation of Peri Vascular Adipose Tissue (PVAT) - volume measurement in millimeters cubed (mm^3) Finally this data will used to investigate the independent predictive significance of CCT-assessed coronary plaque characteristics on event prediction. |
Baseline, 1 month, 1 year |
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