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Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)

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ClinicalTrials.gov Identifier: NCT01090895
Recruitment Status : Recruiting
First Posted : March 23, 2010
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Angina Pectoris Drug: Vitamin C Drug: Placebo Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin C Infusion on Coronary Reperfusion Indexes
Study Start Date : March 2010
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack


Secondary Outcome Measures :
  1. Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging [ Time Frame: 7 days ]
    Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of damage within 7 days after PCI.

  2. Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade) [ Time Frame: post PCI ]
    Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) could improve the reperfusion indexes.

  3. Early incidence of Major Adverse Cardiovascular Events. [ Time Frame: 1 month ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack

  4. Late incidence of Major Adverse Cardiovascular Events. [ Time Frame: 3 months ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other 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
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Francesco Violi, 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