Comprehensive risk assessment after heart attacks using advanced imaging techniques
Cardiac Computed Tomography for Comprehensive Risk Stratification of Arrhythmic, Atherothrombotic and Heart Failure Events Following Reperfused ST-segment Elevation Myocardial Infarction
This study is testing a new imaging method to see if it can better predict heart problems in people who have just had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Messina and 2 other locations) |
| Trial ID | NCT06020209 on ClinicalTrials.gov |
What this trial studies
This study evaluates a comprehensive cardiac computed tomography (CCT) protocol to assess the risk of heart failure, life-threatening arrhythmias, and atherothrombotic events following ST-elevation myocardial infarction (STEMI). It compares the diagnostic accuracy of CCT with cardiac magnetic resonance (CMR), the current non-invasive gold standard, and aims to determine the prognostic value of CCT in assessing myocardial tissue features related to STEMI. Two hundred patients will undergo both CCT and CMR in the post-acute phase, with follow-up focused on monitoring heart failure, arrhythmias, and ischemic events.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with STEMI who have undergone primary percutaneous coronary intervention within 24 hours of symptom onset.
Not a fit: Patients with known chronic kidney disease, severe arrhythmias, or those unable to undergo imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and accessible method for risk stratification in patients recovering from STEMI.
How similar studies have performed: While CMR has been established as a gold standard, this study's approach using CCT for comprehensive risk assessment is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Messina and 2 other locations
- Azienda Ospedaliera Policlinico Universitario "G. Martino" — Messina, Italy (Recruiting)
- Istituto Auxologico Italiano - IRCCS - Ospedale San Luca — Milan, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza - Molinette Hospital — Turin, Italy (Recruiting)
Study contacts
- Principal investigator: Marco Gatti, M.D. — University of Turin, Italy
- Study coordinator: Marco Gatti, M.D.
- Email: m.gatti@unito.it
- Phone: +390116334175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.