Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: March 8, 2016
Last verified: March 2016
  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
Angina Pectoris
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 Coronary Reperfusion Indexes

Resource links provided by NLM:


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: 12 months ] [ Designated as safety issue: Yes ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack


Secondary Outcome Measures:
  • Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of damage within 7 days after PCI.

  • Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade) [ Time Frame: post PCI ] [ Designated as safety issue: No ]
    Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) could improve the reperfusion indexes.

  • Early incidence of Major Adverse Cardiovascular Events. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack

  • Late incidence of Major Adverse Cardiovascular Events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack


Estimated Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin C
Vitamin C infusion
Drug: Vitamin C
Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
Other Name: Ascorbic Acid
Placebo Comparator: Placebo
Saline solution
Drug: Placebo
Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.
Other Name: Saline solution

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Prof.         
Sub-Investigator: Mangieri Enrico, Prof.         
Principal Investigator: Raparelli Valeria, Prof.         
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: March 8, 2016
Health Authority: Italy: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Roma La Sapienza:
Percutaneous Coronary Intervention
Vitamin C
Biomarkers
Magnetic Risonance

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 26, 2016