NCT05122741

Brief 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). 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

September 28, 2021

Last Update Submit

January 21, 2023

Conditions

Myocardial InfarctionMyocardial FibrosisMyocardial Remodeling, Ventricular

Keywords

Myocardial InfarctionBeta-CateninWNT Signaling pathwayAdenosine systemsDual Antiplatelet TherapyTicagrelorPrasugrelMyocardial FibrosisClopidogrel

Outcome Measures

Primary Outcomes (6)

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

    NTproBNP as per center standard dosing

    Measured at 5 days after PCI

  • 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 at 5 days after PCI

  • 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 at 5 days after PCI

  • 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 at 45 day after PCI

  • 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 at 45 day after PCI

  • 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 at 45 day after PCI

Secondary Outcomes (3)

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

    At baseline, 3, 5 and 45 day after PCI

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

    At baseline, 3, 5 and 45 day after PCI

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

    At baseline, 3, 5 and 45 day after PCI

Study Arms (2)

Acute Myocardial Infarction

40 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.

Drug: P2Y12 Potent Inhibitor + Aspirin for STEMI patients

Chronic Coronary Syndrome

10 patients with stable coronary artery disease with an indication, according to current guidelines, to percutaneous coronary intervention and subsequent DAPT with aspirin and clopidogrel.

Drug: Clopidogrel + Aspirin for CCS patients

Interventions

P2Y12 Potent Inhibitor + Aspirin for STEMI patientsDRUG

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

Also known as: DAPT with Potent P2Y12i
Acute Myocardial Infarction
Clopidogrel + Aspirin for CCS patientsDRUG

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

Also known as: DAPT with Clopidogrel
Chronic Coronary Syndrome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Martino

Messina, 98125, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be used to study: * serum concentrations of Adenosine, Beta-Catenin, cAMP * expression mRNAs encoding for Beta-Catenin.

MeSH Terms

Conditions

Myocardial InfarctionVentricular Remodeling

Interventions

Aspirin2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosineClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Francesco Costa

CONTACT

+390902212341dottfrancescocosta@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
45 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 28, 2021

First Posted

November 17, 2021

Study Start

December 1, 2021

Primary Completion

November 1, 2023

Study Completion

December 31, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

IT(1)