NCT01090895

Treatment of Reperfusion Event by Vitamin C Infusion

Effect of Vitamin C Infusion on Coronary Reperfusion Indexes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary Hypothesis: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, assessed by measurements of cardiac biomarkers, during acute myocardial infarction. Secondary Hypotheses: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, as measured by the area of delayed hyperenhancement that was seen on cardiac magnetic resonance imaging (MRI), assessed on day 5 after infarction, during acute myocardial infarction.

Detailed description

This is a multicenter, prospective, controlled, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be randomized to receive during surgical procedure an intravenous infusion of Vitamin C or Placebo. Patients will have repeat clinical follow-up to 5 days, 3 and 6 months and 1 year. The new angiography evaluation will be done if necessary. The study population will consist of at least 100 patients who presented within 12 hours after the onset of chest pain, who had ST-segment elevation of more than 0.1 mV in two contiguous leads, and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). Following confirmation of eligibility criteria, patients will be randomized in a 1:1 ratio to receive prophylactic infusion of Vitamin C or Placebo. The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary Angiography. The incidence of clinical events, including death, myocardial infarction, target vessel revascularization, stent thrombosis, will be evaluated at 1, 3, 6 and, 12 months.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
DRUG	Vitamin C	Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
DRUG	Placebo	Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.

Timeline

• Start date: 2010-03-01
• Primary completion: 2017-10-01
• Completion: 2018-12-01
• First posted: 2010-03-23
• Last updated: 2016-03-09

Locations

1 site across 1 country: Italy