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

October 2, 2023 updated by: Centro Cardiologico Monzino
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Adverse cardiac remodeling is a process of structural and functional changes associated with worse clinical outcomes and increased mortality, which occurs in response to sustained pathophysiological stimuli, such as ST-elevation myocardial infarction (STEMI). Despite the progresses achieved with reperfusion therapy in STEMI, a significant portion of patients still develops adverse remodeling. Cardiovascular Magnetic Resonance (CMR) is the gold standard for clinical diagnosis of adverse remodeling, as it provides reliable and reproducible information on ventricular size, function and tissue damage. However, CMR is not always applicable, due to resources and availability reasons and to patients' contraindications. Therefore, additional markers for the early detection of patients at risk for adverse remodeling after STEMI are needed. Exosomes are small extracellular vesicles released by cells and detectable in all body fluids, including plasma. Their release and cargo are influenced by cellular microenvironment, thus mirroring cell/organ status. Previous study demonstrated that concentration and cargo of plasma exosomes released during STEMI well reflect the pathophysiology of the disease, suggesting their potential as biomarkers. Whether exosome profile analysis could predict adverse remodeling after STEMI remains to be investigated.

The relevant hypothesis to be tested is whether plasma exosomes may help to identify, in an early phase, patients at high risk of adverse remodeling after STEMI, accelerating proper patient management in order to reduce risk of further cardiovascular events and improve outcomes. Overall, this new knowledge will pave the way toward a new strategy to predict adverse remodeling in STEMI patients and to develop patient-tailored therapy.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify whether the profile of circulating plasma exosomes reflects CMR-assessed STEMI severity at hospital discharge
Time Frame: within 3-5 days post PCI
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
Time Frame: 6 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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Andrea Baggiano, MD, IRCCS Centro Cardiologico Monzino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM 1931

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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