STEMIMIRACLENCT06070974
ExosoMe as Integrative Tool for pRognostic Stratification of Adverse Cardiac remodeLing in stEmi Patients: the MIRACLE Study
An observational study of STEMI, run by Centro Cardiologico Monzino at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- CMR and blood collection
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 3 May 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients with acute STEMI will be screened for study eligibility by site personnel to identify those who meet all selection criteria
Who may be able to join
- 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
Who cannot join
- previous myocardial infarction (MI)
- time to pPCI >12 h
- atrial fibrillation
- renal failure with glomerular filtration <30 ml/min
- claustrophobia
- other contraindications to CMR.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, Milan, 20138
Andrea Baggiano, MD, 0258002139, andrea.baggiano@cardiologicomonzino.it
Marta Zarà, PhD, 0258002755, marta.zara@cardiologicomonzino.it
- Recruiting
Istituto Auxologico Italiano
Milan, 20149
Silvia Castelletti, MD, s.castelletti@auxologico.it
About this study
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).
Read the 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.
- Conditions
- STEMI
- Being tested
- CMR and blood collection
- Keywords
- Cardiovascular Magnetic Resonance, PCI, Exosome
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR and blood collectionDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: CMR and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start3 May 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Responsible party
- Sponsor
- Investigators
- Andrea Baggiano, MD, Principal investigator, IRCCS Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070974
- Sponsor's protocol ID
- CCM 1931
- Acronym
- MIRACLE
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28856546Masci 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.
PubMed 31326993Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
PubMed 32029601Zara 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.
PubMed 34360827
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExosoMe as Integrative Tool for pRognostic Stratification of Adverse Cardiac remodeLing in stEmi Patients: the MIRACLE Study
- ClinicalTrials.gov ID
- NCT06070974
- Acronym / sponsor ID
- MIRACLE / CCM 1931
- Conditions
- STEMI
- Keywords
- Cardiovascular Magnetic Resonance, PCI, Exosome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | – | Diagnostic Test: CMR and blood collectionSTEMI 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with acute STEMI will be screened for study eligibility by site personnel to identify those who meet all selection criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- previous myocardial infarction (MI)
- time to pPCI >12 h
- atrial fibrillation
- renal failure with glomerular filtration <30 ml/min
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR and blood collectionAll 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). | Diagnostic test | Single arm study |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 28856546Pontone 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.
- Background: PubMed 31326993Masci 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.
- Background: PubMed 32029601Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
- Background: PubMed 34360827Zara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Baggiano, MD principal investigator
IRCCS Centro Cardiologico Monzino
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Centro Cardiologico Monzino at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Baggiano, MD (0258002139, andrea.baggiano@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify whether the profile of circulating plasma exosomes reflects CMR-assessed STEMI severity at hospital discharge (time frame: within 3-5 days post PCI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070974, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.