Using plasma exosomes to predict heart remodeling in STEMI patients
ExosoMe as Integrative Tool for pRognostic Stratification of Adverse Cardiac remodeLing in stEmi Patients: the MIRACLE Study
This study is trying to see if tiny particles in the blood can help doctors find out which patients are at higher risk for heart problems after a heart attack.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 2 sites (Milano, Milan and 1 other locations) |
| Trial ID | NCT06070974 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to determine if plasma exosomes can identify patients at high risk of adverse cardiac remodeling following ST-elevation myocardial infarction (STEMI). Enrolled patients will undergo blood collection and cardiovascular magnetic resonance imaging three days after successful percutaneous coronary intervention (PCI). The study seeks to correlate exosome profiles with the severity of myocardial infarction to enhance early patient management and reduce future cardiovascular risks. By exploring the potential of exosomes as biomarkers, the study addresses a critical gap in the current understanding of post-STEMI patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals experiencing chest pain indicative of myocardial ischemia and who have undergone successful PCI within 12 hours of symptom onset.
Not a fit: Patients with a history of previous myocardial infarction or those with contraindications to cardiovascular magnetic resonance imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification of patients at risk for adverse cardiac remodeling, allowing for timely interventions.
How similar studies have performed: While the use of exosomes as biomarkers is a relatively novel approach, previous studies have shown promise in their ability to reflect disease pathophysiology in myocardial infarction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * chest pain suggestive of myocardial ischemia lasting \>30 min * electrocardiogram (ECG) showing ST-segment elevation \>0.1 mV in more or equal to 2 limb leads or \>0.2 mV in more or equal to 2 contiguous precordial leads, or presumed new left bundle-branch block * successful treatment with pPCI within 12 h from the onset of symptoms Exclusion Criteria: * previous myocardial infarction (MI) * time to pPCI \>12 h * atrial fibrillation * renal failure with glomerular filtration \<30 ml/min * claustrophobia * other contraindications to CMR.
Where this trial is running
Milano, Milan and 1 other locations
- IRCCS Centro Cardiologico Monzino — Milano, Milan, Italy (Recruiting)
- Istituto Auxologico Italiano — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Baggiano, MD — IRCCS Centro Cardiologico Monzino
- Study coordinator: Andrea Baggiano, MD
- Email: andrea.baggiano@cardiologicomonzino.it
- Phone: 0258002139
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.