CCT for Comprehensive Risk Stratification Following STEMI

NCT06020209 | Recruiting

• 2 other identifiers: CT-STEMIGR-2021-12372092
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Comparing the diagnostic accuracy of the comprehensive CCT protocol with cardiac magnetic resonance (CMR), considered the non-invasive gold standard.
2. 2.Determining the prognostic value of CCT in assessing myocardial tissue adverse features related to STEMI.
3. 3.Evaluating the atherosclerotic burden in patients with post-acute STEMI.

Conditions

Myocardial Infarction

Keywords

ST Elevation Myocardial Infarction; Coronary Artery Disease; Computed Tomography (CT); Cardiovascular Magnetic Resonance (CMR); Risk assessment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

STEMI patients

EXPERIMENTAL

Patients with reperfused ST-segment Elevation Myocardial Infarction

Diagnostic Test: Cardiac Computed Tomography; Diagnostic Test: Cardiac Magnetic Resonance

Interventions

Cardiac Computed Tomography DIAGNOSTIC_TEST

A comprehensive CCT protocol will be performed in the post-acute phase of STEMI. Specifically, the CCT protocol will include a pre-contrast scan and an angiographic scan ( also set up to assess ventricular volume and function) followed by late contrast enhancement scan.

STEMI patients

Cardiac Magnetic Resonance DIAGNOSTIC_TEST

A comprehensive CMR protocol will be performed in the post-acute phase of STEMI. Specifically, the CMR protocol is designed for morpho-functional analysis and tissue characterisation (including assessment of late gadolinium enhancement and mapping). CMR will be considered the gold standard.

STEMI patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Turin, Italy: lead
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator
• Istituto Auxologico Italiano: collaborator
• University of Messina: collaborator
• Ministry of Health, Italy: collaborator

Study Sites (3)

Azienda Ospedaliera Policlinico Universitario "G. Martino"

Messina, 98124, Italy

RECRUITING

Istituto Auxologico Italiano - IRCCS - Ospedale San Luca

Milan, 20149, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza - Molinette Hospital

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Marco Gatti, M.D.

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Gatti, M.D.

CONTACT

+390116334175; m.gatti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 31, 2023
• Study Start: November 8, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)