RecruitingNCT06070974

ExosoMe as Integrative Tool for pRognostic Stratification of Adverse Cardiac remodeLing in stEmi Patients: the MIRACLE Study


Sponsor

Centro Cardiologico Monzino

Enrollment

100 participants

Start Date

May 3, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multicenter observational prospective study aimed to assess whether plasma exosomes can help identify, at an early stage, patients at high risk of adverse remodeling after STEMI (ST-elevation myocardial infarction) , thus accelerating proper patient management in order to reduce the risk of future cardiovascular events. In order to study the correlation between exosome profile and severity of myocardial infarction, consecutive STEMI patients will be enrolled 3 days after Percutaneous Coronary Intervention (PCI).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • previous myocardial infarction (MI)
  • time to pPCI >12 h
  • atrial fibrillation
  • renal failure with glomerular filtration <30 ml/min
  • claustrophobia
  • other contraindications to CMR.

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Interventions

DIAGNOSTIC_TESTCMR and blood collection

All patients enrolled will undergo 2 CMR examination (within 3-5 days post PCI and after six months), and blood collection at third day after PCI (T0). Patients recruited at Centro Cardiologico Monzino will be subjected to a blood withdrawal also at different time points: 1- 3- 6 months after STEMI (T1, T2, and T3 respectively).


Locations(2)

IRCCS Centro Cardiologico Monzino

Milan, Milan, Italy

Istituto Auxologico Italiano

Milan, Italy

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NCT06070974


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