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

NCT06070974 | Recruiting

• 1 other identifier: CCM 1931
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

STEMI

Keywords

Cardiovascular Magnetic Resonance; PCI; Exosome

Outcome Measures

Primary Outcomes (3)

• Verify whether the profile of circulating plasma exosomes reflects CMR-assessed STEMI severity at hospital discharge

  Assess the ability of exosome profile, detected in the blood sample 3 days after PCI (T0),to reflect STEMI severity as assessed by CMR and evaluate the correlation of T0 exosome profile with clinicopathological features.

  within 3-5 days post PCI

• Evaluate whether exosome profile in the acute phase of hospitalization after STEMI predicts adverse remodeling at six months

  Assess the ability of T0 exosomes to predict adverse cardiac remodeling, both alone or in combination with CMR analysis and discover new exosome candidates able to predict adverse cardiac remodeling

  6 months

• Assess whether changes in exosomes profile a different time points following STEMI (1-3-6 months) reflects clinical outcome

  Evaluate the change of exosomes profile during time and test the correlation of exosomes change during time or at specific time points with clinical complication and outcome

  6 months

Study Arms (1)

Single arm study

STEMI patients, who meet all the inclusion and none of the exclusion criteria, will be enrolled 3 days after PCI to study the correlation between exosome profile and severity of myocardial infarction

Diagnostic Test: CMR and blood collection

Interventions

CMR and blood collection DIAGNOSTIC_TEST

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).

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with acute STEMI will be screened for study eligibility by site personnel to identify those who meet all selection criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Istituto Auxologico Italiano: collaborator

Study Sites (2)

IRCCS Centro Cardiologico Monzino

Milan, Milan, 20138, Italy

RECRUITING

Istituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

Related Publications (4)

• Pontone G, Carita P, Rabbat MG, Guglielmo M, Baggiano A, Muscogiuri G, Guaricci AI. Role of Cardiac Magnetic Resonance Imaging in Myocardial Infarction. Curr Cardiol Rep. 2017 Aug 31;19(10):101. doi: 10.1007/s11886-017-0907-1.

  PMID: 28856546 BACKGROUND

• Masci PG, Pavon AG, Pontone G, Symons R, Lorenzoni V, Francone M, Zalewski J, Barison A, Guglielmo M, Aquaro GD, Galea N, Muscogiuri G, Muller O, Carbone I, Baggiano A, Iglesias JF, Nessler J, Andreini D, Camici PG, Claus P, de Luca L, Agati L, Janssens S, Schwitter J, Bogaert J. Early or deferred cardiovascular magnetic resonance after ST-segment-elevation myocardial infarction for effective risk stratification. Eur Heart J Cardiovasc Imaging. 2020 Jun 1;21(6):632-639. doi: 10.1093/ehjci/jez179.

  PMID: 31326993 BACKGROUND

• Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.

  PMID: 32029601 BACKGROUND

• Zara M, Campodonico J, Cosentino N, Biondi ML, Amadio P, Milanesi G, Assanelli E, Cerri S, Biggiogera M, Sandrini L, Tedesco CC, Veglia F, Trabattoni D, Blandini F, Tremoli E, Marenzi G, Barbieri SS. Plasma Exosome Profile in ST-Elevation Myocardial Infarction Patients with and without Out-of-Hospital Cardiac Arrest. Int J Mol Sci. 2021 Jul 28;22(15):8065. doi: 10.3390/ijms22158065.

  PMID: 34360827 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood collection for exosome isolation and analysis

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Andrea Baggiano, MD

  IRCCS Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Baggiano, MD

CONTACT

0258002139; andrea.baggiano@cardiologicomonzino.it

Marta Zarà, PhD

CONTACT

0258002755; marta.zara@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 6, 2023
• Study Start: May 3, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

IT (2)