Cardio-protective Effect of Metformin in Patients Undergoing PCI

Study Overview
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Brief Summary
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This is a two-arm randomized parallel study. Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study. The whole study protocol were presented to the local institutional review board (IRB).

Official Title
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Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention

Conditions
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Elective Percutaneous Coronary Intervention, Ischemic Reperfusion Injury

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age above 18) Undergoing elective PCI Exclusion Criteria: Hypersensitivity to metformin or any component of the formulation Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome. Patients diagnosed with type 1 or 2 diabetes mellitus. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas) Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis). Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels). Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel). Need for coronary artery bypass grafting. Participation in other clinical trial in the 30 days before enrollment. The existence of a life-threatening disease with a life-expectancy of less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin Group<br>Patients will receive pre-treatment standard and post treatment of care to the procedure plus metformin 500 mg twice daily 7 days before and 6 months after the PCI procedure. Metformin will be stopped on the same day of the procedure and restored 3 hours after the procedure. | Drug: Metformin<br>* Metformin 500 mg twice<br>|
| No Intervention: Comparator<br>Patients will receive pre-treatment and post treatment standard of care to the procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprocedural myocardial injury | the occurrence of postprocedural myocardial injury, defined as a postprocedural elevation of CKMB or cTnI more than 1 times the 99 th percentile of the URL [ 24 hours post PCI] | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CK-MB | Mean peak values of CK-MB after intervention | 24 hours post PCI | 
| cTn | Mean peak values of cTnI after intervention | 24 hours post PCI | 
| LVEF in percent | Echo: to measure LVEF in percent | Baseline- 6 months | 
| LVMI in g/m2 | left ventricular mass index (LVMI) will be calculated in g/m2 using the sex and body surface area (m²) and measures of LVEDD in mm, IVSd in mm, PWd from the measures in the echocardiography | Baseline- 6 months | 
| GFR | glomerular filtration rate (GFR) will be calculated (unit ml/min) using age in years, sex, body weight in kilograms and serum creatinine in mg/dL | Baseline- monthly- 6 months | 
| Serum creatinine (SCr) | Serum creatinine (SCr) in mg/dL | Baseline- monthly- 6 months | 
| Lactate concentration | lactate concentration unit in mmol/L | Baseline - 6 months | 
| Glucometabolic State | Glucometabolic State using HbA1c (unit mmols/mol) | Baseline - 6 months | 
| Incidence of Cardiovascular Event | Cardiovascular events including major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non- cardiac. Cardiac death will be divided into three categories: heart failure, sudden death, and others. | Baseline - 6 months | 
| Rate of hospitalization | The number of hospitalizations within each group will be calculated during the study period. | through study completion, an average of 6 months |