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| Name | Class |
|---|---|
| Cairo University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Group | Experimental | 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. |
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| Comparator | No Intervention | Patients will receive pre-treatment and post treatment standard of care to the procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 500 mg twice |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Cairo University | Cairo | Egypt | ||||
| Kasr El Aini Hospital |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 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 |
| Cairo |
| Egypt |
| Kasr El-Aini Hospital | Cairo | Egypt |