CCT for Comprehensive Risk Stratification Following STEMI
NCT ID: NCT06020209
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2023-11-08
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
STEMI patients
Patients with reperfused ST-segment Elevation Myocardial Infarction
Cardiac Computed Tomography
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.
Cardiac Magnetic Resonance
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardiac Computed Tomography
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.
Cardiac Magnetic Resonance
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
A.O.U. Città della Salute e della Scienza - Molinette Hospital
OTHER
Istituto Auxologico Italiano
OTHER
University of Messina
OTHER
Ministry of Health, Italy
OTHER_GOV
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Gatti
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marco Gatti, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tommaso D'Angelo, M.D.
Role: primary
Camilla Torlasco, M.D.
Role: primary
Marco Gatti, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GR-2021-12372092
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CT-STEMI
Identifier Type: -
Identifier Source: org_study_id