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Myocardial InfarctionBETA-MINCT05122741

Modulation of Fibrosis-inducing Pathways in Acute Myocardial Infarction

An observational study of Myocardial Infarction and Myocardial Fibrosis, run by University of Messina at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, prospective, observational controlled cohort study designed to describe the role of WNT/B-catenin signaling and adenosine system after an acute myocardial infarction, correlating it with clinical markers of fibrosis/remodeling (primary objective). Read more about this study

Who is it for?
Any age
What is being tested?
P2Y12 Potent Inhibitor + Aspirin for STEMI patients and Clopidogrel + Aspirin for CCS patients
How many people
50 participants
Where
1 siteItaly
Study dates
1 Dec 2021to 31 Dec 2023
How long will I take part?
45 Days
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population will consist of patients planned to undergo percutaneous coronary revascularization. A total of 50 patients will be enrolled in the study, 40 with clinical presentation of acute myocardial infarction with an indication for primary percutaneous coronary intervention and eligible for treatment with either prasugrel or ticagrelor, and a control cohort of 10 patients with stable coronary artery disease and no history of prior myocardial infarction who are not indicated for treatment with potent P2Y12 inhibitors. To ensure comparability the study and control groups, the control cohort will be matched to exclude a potential confounder effect of age, sex and other established risk factors.

Who may be able to join

  • Patients with ST segment elevation acute myocardial infarction undergoing coronary angiography and interventional treatment.*
  • Patients with chronic coronary syndrome matched by age, sex and risk factors will also be screened and included as per study design.
  • Patients with an indication to potent P2Y12 inhibitor therapy (i.e. ticagrelor or prasugrel) for acute myocardial infarction.
  • Population equally amenable to ticagrelor or prasugrel therapy according to the italian drug instruction of use (IFU)

Who cannot join

  • Patients with a poor prognosis (less than 12 months)
  • Patients admitted with cardiogenic shock or advanced cardiac failure (NYHA 4)
  • Patients pre-treated before coronary angiography or in chronic therapy with a P2Y12 inhibitor
  • Patients undergoing a medical only approach without percutaneous myocardial revascularization
  • Patients undergoing surgical coronary revascularization
  • Patients with prior history of myocardial infarction or prior coronary revascularization.
Show all 17Show fewer
  • Patients with contraindications or intolerance to antiplatelet therapy (ticagrelor, prasugrel, clopidogrel or cardioaspirin)
  • Patients scheduled for a treatment with with cangrelor or GPIIb/IIIa inhibitors
  • Patients with active bleeding at the time of inclusion
  • Hemorrhagic diathesis
  • Confirmed history of renal failure with glomerular filtration rate of <30ml/min
  • Severe hepatopathy
  • Patients treated or scheduled for treatment with oral anticoagulant therapy
  • Active cancer or diagnosis any proliferative disease within 5 years.
  • Prior TIA or stroke (ischemic or hemorrhagic)
  • Age >75 years
  • Weight <60kg

Trial locations and contacts

1 site in 1 country.

Francesco Costa contact

+390902212341

dottfrancescocosta@gmail.com

Italy1 site, 1 recruiting

  • AOU Policlinico G. Martino

    Messina, 98125

    Francesco Costa, Medicine, dottfrancescocosta@gmail.com

    Roberto Licordari, Medicine, robertolicordari@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Modulation of the WNT/Beta-Catenin Pathway in Patients With Acute Myocardial Infarction

This is a single-center, prospective, observational controlled cohort study designed to describe the role of WNT/B-catenin signaling and adenosine system after an acute myocardial infarction, correlating it with clinical markers of fibrosis/remodeling (primary objective). The modulation of the aforementioned molecular patterns will also be evaluated in light of the type of P2Y12 inhibitor implemented (ticagrelor or prasugrel) to identify variations in response (secondary objective).

Read the detailed description

A total of 50 patients will be enrolled in the study, 40 with clinical presentation of acute myocardial infarction and eligible for treatment with either prasugrel or ticagrelor, and a control cohort of 10 patients with stable coronary artery disease, matched for age, sex and major risk factors, and with no history of prior myocardial infarction.

The study has been approved by the local ethics committee on 22/09/2021. Pre-enrollment screening will start from 01/11/2021. Blood samples will be obtained at 5 time-points: before and immediately after coronary revascularization (PCI) through the arterial introducer, and in the ward / clinic at a distance of 3, 5 days and 45±15 days from the procedure during normal routine examinations.

These will be used to study the expression of messenger RNA encoding for beta-catenin and to dose concentrations of beta-catenin, adenosine and cyclic adenosine monophosphate (cAMP) on serum. The extraction of RNA from blood samples will be carried out with a Real-time PCR method and the determination of molecules using ELISA colorimetric method, using specific kits.

Clinical-laboratory markers of left ventricular remodeling such as NT-proBNP, hsTnT, C-reactive protein, CK-MB, 12-lead ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging, will be evaluated during hospitalization (at 3 and 5 days) and at the control visit (at 45 ± 15 days) as per standard clinical practice.

Being tested
P2Y12 Potent Inhibitor + Aspirin for STEMI patients, Clopidogrel + Aspirin for CCS patients
Keywords
Myocardial Infarction, Beta-Catenin, WNT Signaling pathway, Adenosine systems, Dual Antiplatelet Therapy, Ticagrelor, Prasugrel, Myocardial Fibrosis, Clopidogrel
Medical subject headings
Myocardial Infarction, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P2Y12 Potent Inhibitor + Aspirin for STEMI patientsDrug

    Also called DAPT with Potent P2Y12i

    Patients will undergo primary percutaneous coronary intervention and DAPT with potent P2Y12 inhibitor (ticagrelor or prasugrel + aspirin)

  • Clopidogrel + Aspirin for CCS patientsDrug

    Also called DAPT with Clopidogrel

    Patients will undergo elective percutaneous coronary intervention and DAPT with non-potent P2Y12 inhibitor (clopidogrel + aspirin)

Study groups in NCT05122741
Study groupRoleWhat they receive
Acute Myocardial Infarction40 patients with clinical presentation of acute myocardial infarction undergoing primary percutaneous coronary intervention and eligible for dual antiplatelet therapy (DAPT) with either prasugrel or ticagrelor on top of aspirin.
Receives: Drug: P2Y12 Potent Inhibitor + Aspirin for STEMI patients
Chronic Coronary Syndrome10 patients with stable coronary artery disease with an indication, according to current guidelines, to percutaneous coronary intervention and subsequent DAPT with aspirin and clopidogrel.
Receives: Drug: Clopidogrel + Aspirin for CCS patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between WNT/B-catenin levels and NTproBNP in patients presenting with acute myocardial infarction

    NTproBNP as per center standard dosing

    Measured: Measured at 5 days after PCI

  2. Correlation between WNT/B-catenin levels and and left ventricular ejection fraction in patients presenting with acute myocardial infarction

    Left ventricular ejection fraction will be measured with transthoracic Echocardiography at the specified timepoint

    Measured: Measured at 5 days after PCI

  3. Correlation between WNT/B-catenin levels and and extent of myocardial necrosis in patients presenting with acute myocardial infarction

    Extent of myocardial necrosis will be measured with Carciac Magnetic Resonance Imaging at the specified timepoint

    Measured: Measured at 5 days after PCI

  4. Correlation between in hospital WNT/B-catenin levels and NTproBNP at follow-up in patients presenting with acute myocardial infarction

    NTproBNP as per center standard dosing

    Measured: Measured at 45 day after PCI

  5. Correlation between in-hospital WNT/B-catenin levels and left ventricular ejection fraction at follow-up in patients presenting with acute myocardial infarction

    Left ventricular ejection fraction will be measured with transthoracic Echocardiography at the specified timepoint

    Measured: Measured at 45 day after PCI

  6. Correlation between in-hospital WNT/B-catenin levels and extent of myocardial fibrosis at follow-up in patients presenting with acute myocardial infarction

    Extent of myocardial fibrosis will be measured with Carciac Magnetic Resonance Imaging at the specified timepoint

    Measured: Measured at 45 day after PCI

Secondary outcomes (3)

  1. Differences in WNT/B-catenin levels according to clinical presentation

    Differences in results of activation of these molecular pathways in patients presenting with acute myocardial infarction and those selected in the control group by age, sex and risk factor matching

    Measured: At baseline, 3, 5 and 45 day after PCI

  2. Differences in WNT/B-catenin levels in patients treated with ticagrelor or prasugrel

    Differences in results of activation of these molecular pathways in patients treated with ticagrelor or prasugrel presenting with acute myocardial infarction

    Measured: At baseline, 3, 5 and 45 day after PCI

  3. Differences in WNT/B-catenin levels in patients treated with or without Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors

    Differences in results of activation of these molecular pathways in patients treated or not treated with Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors after acute myocardial infarction

    Measured: At baseline, 3, 5 and 45 day after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
50 participants (estimated)
Target duration
45 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05122741
Sponsor's protocol ID
Cardio1
Acronym
BETA-MI
Status last verified
Jan 2023
First submitted
28 Sep 2021
Last updated
25 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction and Myocardial Fibrosis, run by University of Messina at 1 site 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 4 inclusion and 17 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Francesco Costa (+390902212341, dottfrancescocosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between WNT/B-catenin levels and NTproBNP in patients presenting with acute myocardial infarction (time frame: Measured at 5 days after PCI). The study lists 6 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 NCT05122741.

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 25 Jan 2023.

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