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Open Access Study protocol

The effectiveness of antioxidant vitamins C and E in reducing myocardial infarct size in patients subjected to percutaneous coronary angioplasty (PREVEC Trial): study protocol for a pilot randomized double-blind controlled trial

Ramón Rodrigo1*, Daniel Hasson1, Juan C Prieto12, Gastón Dussaillant2, Cristóbal Ramos3, Lucio León4, Javier Gárate4, Nicolás Valls1 and Juan G Gormaz1

Author Affiliations

1 Molecular and Clinical Pharmacology Program, Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Santiago, Chile

2 Cardiovascular Department, University of Chile Clinical Hospital, Santiago, Chile

3 Department of Radiology, University of Chile Clinical Hospital, Santiago, Chile

4 Cardiovascular Center, San Borja Arriarán Clinical Hospital, Santiago, Chile

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Trials 2014, 15:192  doi:10.1186/1745-6215-15-192

Published: 29 May 2014

Abstract

Background

Acute myocardial infarction (AMI) is the leading cause of mortality worldwide. Oxidative stress has been involved in the ischemia-reperfusion injury in AMI. It has been suggested that reperfusion accounts for up to 50% of the final size of a myocardial infarct, a part of the damage likely to be prevented.Therefore, we propose that antioxidant reinforcement through vitamins C and E supplementation should protect against the ischemia-reperfusion damage, thus decreasing infarct size.

The PREVEC Trial (Prevention of reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction) seeks to evaluate whether antioxidant vitamins C and E reduce infarct size in patients subjected to percutaneous coronary angioplasty after AMI.

Methods/Design

This is a randomized, 1:1, double-blind, placebo-controlled clinical trial.

The study takes place at two centers in Chile: University of Chile Clinical Hospital and San Borja Arriarán Clinical Hospital.

The subjects will be 134 adults with acute myocardial infarction with indication for percutaneous coronary angioplasty.

This intervention is being performed as a pilot study, involving high-dose vitamin C infusion plus oral administration of vitamin E (Vitamin-treatment group) or placebo (Control group) during the angioplasty procedure. Afterward, the Vitamin-treatment group receives oral doses of vitamins C and E, and the Control group receives placebo for 84 days after coronary angioplasty.

Primary outcome is infarct size, assessed by cardiac magnetic resonance (CMR), measured 6 and 84 days after coronary angioplasty.

Secondary outcomes are ejection fraction, measured 6 and 84 days after coronary angioplasty with CMR, and biomarkers for oxidative stress, antioxidant status, heart damage, and inflammation, which will be measured at baseline, at the onset of reperfusion, 6 to 8 hours after revascularization, and at hospital discharge.

Discussion

The ischemia-reperfusion event occurring during angioplasty is known to increase myocardial infarct size. The cardioprotective benefits of high doses of vitamin C combined with vitamin E have not been fully explored. The PREVEC Trial seeks to determine the suitability of the therapeutic use of vitamins C and E against the reperfusion damage produced during angioplasty.

Patient recruitment opened in February 2013. The trial is scheduled to end in March 2016.

Trial registration

ISRCTN56034553

Keywords:
Percutaneous coronary angioplasty; Ischemia-reperfusion; Oxidative stress; Vitamin C; Vitamin E; Acute myocardial infarction