Effect of coenzyme Q10 versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty: a double-blind randomized clinical trial

To assess the effect of coenzyme Q10 versus placebo on the prevention of contrast medium-induced nephropathy in patients undergoing primary angioplasty

This is a double-blind randomized clinical trial, phase III, in which 50 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients undergoing primary angioplasty referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.

Inclusion criteria: Age 18 to 75 years; Symptoms of persistent myocardial ischemia for at least 30 minutes; Less than 12 hours after the onset of heart attack symptoms; Increased ST segment on electrocardiogram; Treated with primary angioplasty; Exclusion criteria: Consumption of any antioxidants in the past month; Indication of cardiac bypass surgery; History of myocardial infarction or angioplasty; Indication of thrombolytic therapy; Cardiogenic shock; History of heart failure; Advanced liver failure or autoimmune or inflammatory diseases

Intervention group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule Q10 400 mg (manufactured by Dana Pharmaceutical Co.) single dose immediately before angioplasty and then 200 mg every 12 hours for 3 days Control group: Routine treatment (angiotensin inhibitors, statin, anti-placket, beta-blockers) plus one capsule placebo as a single-dose immediately before angioplasty and then one capsule every 12 hours for 3 days

Primary outcome: Nephropathy Secondary outcome: Serum level of CRP

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.