Cardio-protective Effect of Metformin in Patients Undergoing PCI

Ischemic Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05708053
• Other study ID #: December-2019
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 9, 2019
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age above 18)

• Undergoing elective PCI

Exclusion Criteria:

1. Hypersensitivity to metformin or any component of the formulation

2. Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.

3. Patients diagnosed with type 1 or 2 diabetes mellitus.

4. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)

5. 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).

6. Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).

7. Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).

8. Need for coronary artery bypass grafting.

9. Participation in other clinical trial in the 30 days before enrollment.

10. The existence of a life-threatening disease with a life-expectancy of less than 6 months.

Related Conditions & MeSH terms

• Elective Percutaneous Coronary Intervention
• Ischemic Reperfusion Injury
• Reperfusion Injury

Intervention

Drug:
• Metformin
Metformin 500 mg twice

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Cairo University	Cairo
Egypt	Kasr El Aini Hospital	Cairo
Egypt	Kasr El-Aini Hospital	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Future University in Egypt	Cairo University, Cairo University Hospitals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CK-MB	Mean peak values of CK-MB after intervention	24 hours post PCI
Secondary	cTn	Mean peak values of cTnI after intervention	24 hours post PCI
Secondary	LVEF in percent	Echo: to measure LVEF in percent	Baseline- 6 months
Secondary	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
Secondary	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
Secondary	Serum creatinine (SCr)	Serum creatinine (SCr) in mg/dL	Baseline- monthly- 6 months
Secondary	Lactate concentration	lactate concentration unit in mmol/L	Baseline - 6 months
Secondary	Glucometabolic State	Glucometabolic State using HbA1c (unit mmols/mol)	Baseline - 6 months
Secondary	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
Secondary	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