Clinical trial NCT06020209: CCT for Comprehensive Risk Stratification Following STEMI
Official title: Cardiac Computed Tomography for Comprehensive Risk Stratification of Arrhythmic, Atherothrombotic and Heart Failure Events Following Reperfused ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: ST Elevation Myocardial Infarction
Coronary Artery Disease
Computed Tomography (CT)
Cardiovascular Magnetic Resonance (CMR)
Risk assessment
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Istituto Auxologico Italiano
name: University of Messina
name: Ministry of Health, Italy
First posted: 2023-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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. 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.

Detailed description: Background / State of Art

STEMI remains a leading cause of mortality. In the first year, STEMI survivors face an incident burden of heart failure (HF) as high as 25%, of ischemic events up to 18.3% and of LTA up to 1.5%.

CMR has emerged as the most potent tool to predict adverse left ventricular (LV) remodeling following STEMI. Infarct size (IS), microvascular obstruction (MVO) and intramyocardial hemorrhage (IMH) measured by CMR are all independent HF predictors, able to outperform clinical and reperfusion parameters and to predict long-term adverse remodeling among patients with initially preserved LV ejection fraction (LVEF).

Systematic CMR implementation following STEMI into routine clinical practice is difficult for several reasons, including limited availability, high costs as well as practical issues such as time and staff allocation. Moreover, CMR does not assess the coronary tree failing to provide a risk assessment comprehensive of the atherothrombotic component, beyond HF and arrhythmias.

Since recent advances in CCT technology have expanded its applicability beyond accurate morpho-functional assessment to the characterization of the myocardium, allowing for quantification of IS, MVO and extracellular volume (ECV). CCT may now offer unprecedent opportunities to provide a comprehensive risk assessment following STEMI with an ever-increasing available technology, with moderate costs and logistic effectiveness, and with very low radiation dose exposure with current scanners and protocols.

Hypotesis and Significance

Despite giant leaps forward in the acute and chronic management, STEMI remains a leading cause of mortality and morbidity worldwide.

Risk stratification is the foundation to tailoring treatment selection and intensity. However, the current tools to predict adverse events following STEMI including HF development, recurrent atherothrombotic events and life-threatening arrhythmias have poor prediction abilities or require cumbersome and often unavailable diagnostic technologies.

CMR has emerged as the most potent tool to predict adverse LV) remodeling following STEMI. Current post-MI arrhythmic risk stratification to mandate implantable cardioverter defibrillator implantation is chiefly based on LV EF. However, the evaluation of scar burden by CMR may outperform EF to predict life-threatening arrhythmias and has the potential to improve management among patients without a current indication for an implantable cardioverter defibrillator.

Systematic CMR implementation following STEMI into routine clinical practice is difficult for several reasons, including limited availability, high costs as well as practical issues such as time and staff allocation. Moreover, while providing excellent myocardial tissue characterization, CMR does not assess the coronary tree failing to provide a risk assessment comprehensive of the atherothrombotic component, beyond HF and arrhythmias.

Since recent advances in CCT technology have expanded its applicability beyond accurate morpho-functional assessment to the characterization of the myocardium, CCT may now offer unprecedent opportunities to provide a comprehensive risk assessment following STEMI with an ever-increasing available technology, with moderate costs and logistic effectiveness, and with very low radiation dose exposure with current scanners and protocols.

While preliminary data on the CCT performance to assess myocardial tissue characteristics are promising, accurate validation of this technology against CMR and clinical outcomes in large populations will be pivotal for clinical implementation. Moreover, the application of this technology to stratify HF and arrhythmic risk following STEMI has never been assessed.

The CT-STEMI study will be the first to assess the potential of CCT to provide a comprehensive risk assessment following STEMI in a large contemporary population, to lay the bases for a paradigm shift in post-STEMI risk stratification.

Specific Aim 1 To compare the diagnostic accuracy of a comprehensive CCT protocol to that of CMR, the non-invasive gold standard.

Specific Aim 2 To determine the prognostic value of CCT-assessed myocardial tissue STEMI-related adverse features.

Specific Aim 3 To evaluate the atherosclerotic burden in patients with post-acute STEMI.

For this purpose, in this prospective study, a total of two hundred patients will be recruited and undergo coronary computed tomography (CCT) and cardiac magnetic resonance imaging (CMR) during the post-acute phase of ST-elevation myocardial infarction (STEMI).

Experimental Design Aim 1

The CMR study will be used as the reference standard to assess the accuracy of CCT in evaluating morpho-functional parameters such as Left Ventricular End-Diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV), LVEF, Right Ventricular End-Diastolic Volume (RVEDV), Right Ventricular End-Systolic Volume (RVESV), and Right Ventricular Ejection Fraction (RVEF). Additionally, the study will also examine myocardial tissue characteristics including IS, myocardial edema, MVO, IMH, and ECV.

Experimental Design Aim 2

The patients will undergo follow-up procedures starting from the commencement of the study. Co-primary endpoints will be:

* Atherothrombotic primary endpoint: composite of recurrent acute coronary syndrome, ischemic stroke or cardiovascular death
* HF and arrhythmic primary endpoint: composite of new congestive HF or sustained ventricular arrhythmia or appropriate Implantable Cardioverter-Defibrillator (ICD) intervention or sudden cardiac death or resuscitated cardiac arrest

Individual CCT predictors (EF, IS, myocardial edema, MVO, IMH and ECV) will be evaluated and compared with those derived from CMR.

Experimental Design Aim 3

The purpose of this sub-study is to report the prevalence and features of non-culprit plaques, as well as to investigate the independent predictive significance of CCT-assessed coronary plaque characteristics on event prediction.

Eligibility criteria: 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)

Primary outcomes:
measure: CCT - diagnostic accuracy
timeFrame: Baseline
measure: CCT - risk stratification
timeFrame: 1 month, 1 year
measure: CCT - Coronary artery disease (CAD) impact of risk stratification
timeFrame: Baseline, 1 month, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Azienda Ospedaliera Policlinico Universitario "G. Martino"
city: Milan
country: Italy
facility: Istituto Auxologico Italiano - IRCCS - Ospedale San Luca
city: Turin
country: Italy
facility: A.O.U. Città della Salute e della Scienza - Molinette Hospital
Study officials:
affiliation: University of Turin, Italy
name: Marco Gatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: