Modulation of Fibrosis-inducing Pathways in Acute Myocardial Infarction
NCT ID: NCT05122741
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-12-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
P2Y12 Potent Inhibitor + Aspirin for STEMI patients
Patients will undergo primary percutaneous coronary intervention and DAPT with potent P2Y12 inhibitor (ticagrelor or prasugrel + aspirin)
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.
Clopidogrel + Aspirin for CCS patients
Patients will undergo elective percutaneous coronary intervention and DAPT with non-potent P2Y12 inhibitor (clopidogrel + aspirin)
Interventions
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P2Y12 Potent Inhibitor + Aspirin for STEMI patients
Patients will undergo primary percutaneous coronary intervention and DAPT with potent P2Y12 inhibitor (ticagrelor or prasugrel + aspirin)
Clopidogrel + Aspirin for CCS patients
Patients will undergo elective percutaneous coronary intervention and DAPT with non-potent P2Y12 inhibitor (clopidogrel + aspirin)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\* 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)
Exclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Natasha Irrera
UNKNOWN
Gianluca Di Bella
UNKNOWN
Antonio Micari
UNKNOWN
Roberto Licordari
UNKNOWN
University of Messina
OTHER
Responsible Party
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Francesco Costa
Doctor
Locations
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AOU Policlinico G. Martino
Messina, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Cardio1
Identifier Type: -
Identifier Source: org_study_id
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