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Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)

This study is currently recruiting participants.
Verified November 2012 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01090895
First received: March 18, 2010
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
 Drug: Vitamin C
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin C Infusion on Reperfusion Injury in Acute Myocardial Infarction.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack

  • Size of the infarct, assessed by measurements of cardiac biomarkers. [ Time Frame: 3-5 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Size of the infarct assed by cardiac magnetic resonance imaging [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin C Drug: Vitamin C
After baseline collection of blood samples, computer-generated random sequence were used for randomization to an intravenous infusion of vitamin C (1 g/L of saline solution at 24 mg/min) or placebo(saline solution) during intervention. Less than 10 minutes before direct stenting, the patients received the intravenous infusion.
Placebo Comparator: Placebo Drug: Placebo
After baseline collection of blood samples, computer-generated random sequence were used for randomization to an intravenous infusion of vitamin C (1 g/L of saline solution at 24 mg/min) or placebo(saline solution) during intervention. Less than 10 minutes before direct stenting, the patients received the intravenous infusion.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 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)
  • Patients will be eligible for the study whether they were undergoing primary PCI.
  • Signed written informed consent

Exclusion Criteria:

  • Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous acute myocardial infarction, or angina within 48 hours before infarction were not included in the study
  • Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on initial coronary angiography (at the time of admission) will be excluded
  • The patient has impaired renal function (creatinine > 3.0 mg/dl)
  • The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, contrast media or stainless steel that cannot be managed medically
  • The patient needs therapy with warfarin
  • The patient has a life expectancy less than 12 months
  • Recipient of heart transplant
  • The patient is currently participating in an investigational drug or another device study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090895

Contacts
Contact: Francesco Violi, Full Prof +39-06-4461933 francesco.violi@uniroma1.it
Contact: Stefania Basili, Ass Prof +39-06-49974678 stefania.basili@uniroma1.it

Locations
Italy
Sapienza Università di Roma Recruiting
Rome, Italy, 00161
Contact: Francesco Violi, Full Prof     +39-06-4461933     francesco.violi@uniroma1.it    
Contact: Stefania Basili, Ass Prof     +39-06-49974678     stefania.basili@uniroma1.it    
Sub-Investigator: Tanzilli Gaetano, Res            
Sub-Investigator: Mangieri Prof. Enrico, MD            
Sub-Investigator: Andrea Dr Celestini, MD            
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Chair: Francesco Violi, Full Prof Divisione di Prima Clinica Medica - Sapienza University of Rome
  More Information

Publications:

Responsible Party: Francesco Violi, Full professor of internal medicine, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01090895     History of Changes
Other Study ID Numbers: Violi012009
Study First Received: March 18, 2010
Last Updated: November 27, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Myocardial Infarction
Vitamin C
biomarkers
Magnetic Risonance

Additional relevant MeSH terms:
Ascorbic Acid
Infarction
Myocardial Infarction
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Postoperative Complications
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013