No Reflow Phenomenon, Reperfusion Injuries, Myocardial, Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, Coronary Artery Disease (CAD), PCI, Sodium Glucose Co-Transporter 2 Inhibitors, Empagliflozin, Dapagliflozin
Conditions
Keywords
No Reflow Phenomenon, Myocardial Infarction, Sodium Glucose Co-Transporter 2 Inhibitors, Empagliflozin, Dapagliflozin
Brief summary
Study Background & Purpose: The no-reflow phenomenon is a significant complication occurring in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). It leads to poor myocardial perfusion despite successful opening of the culprit coronary artery. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardioprotective mechanisms beyond glucose control. Objective: This randomized controlled trial aims to evaluate the effectiveness and safety of administering SGLT2 inhibitors as adjunctive therapy in reducing the incidence of the no-reflow phenomenon in patients with myocardial infarction undergoing PCI. Study Plan: Eligible patients presenting with myocardial infarction scheduled for PCI will be randomized into three groups: one group receiving standard pharmacological care plus Empagliflozin therapy, second group receiving standard pharmacological care plus dapagliflozin therapy, and the control group receiving standard pharmacological care alone. Patients will be monitored during and after the procedure to evaluate coronary blood flow and incidence of no reflow phenomenon.
Interventions
Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines in addition to empagliflozin orally as a single oral dose before PCI, followed by empagliflozin orally once daily for three days.
DRUGdapagliflozin
Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines in addition to dapagliflozin orally as a single oral dose before PCI, followed by dapagliflozin orally once daily for three days.
DRUGStandard medical treatment
Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines and undergo percutaneous coronary intervention without receiving any study medication.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult male or female patients aged 18-75 years. * Confirmed acute myocardial infarction. * Will undergo percutaneous coronary intervention (PCI). * Ability to receive the study medication before PCI without delaying the clinically indicated procedure. * Ability and willingness to provide written informed consent and comply with the study protocol.
Exclusion criteria
Patients meeting any of the following criteria will be excluded: * Hemodynamically unstable patients(systolic blood pressure \<90 mmHg or mean arterialpressure \< 60 mmHg). * History of coronary artery bypass graft surgery. * Ongoing treatment with SGLT2 inhibitors. * Known allergy to SGLT2 inhibitors. * Acute kidney injury or estimated glomerular filtration rate \<30 mL/min/1.73 m². * Severe hepatic impairment. * Type 1 diabetes mellitus or history of diabetic ketoacidosis. * Active infection or recurrent urinary/genital infections. * Severe dehydration or clinical condition predisposing to volume depletion. For women of childbearing age: * Current or planned pregnancy or lactation. * Current Participation in another clinical trial or having participated in the week prior to recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of angiographic no-reflow/impaired myocardial reperfusion | Periprocedural(At completion of PCI) | Angiographic no-reflow/impaired myocardial reperfusion, defined as TIMI flow grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Contrast induced-Acute Kidney injury(CI-AKI) | up to 72 hours Post PCI | Contrast induced-Acute Kidney injury(CI-AKI) measured by serum creatinine |
Countries
Egypt
Contacts
CONTACTMennatullah Wael Abd El Samie, Bachelor's Degree in Pharmacy
Outcome results
None listed