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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Active Comparator | Vitamin C infusion |
|
| Placebo | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events. | Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging | Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of damage within 7 days after PCI. | 7 days |
| Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Violi, Full Prof | Contact | +39-06-4461933 | francesco.violi@uniroma1.it | |
| Stefania Basili, Ass Prof | Contact | +39-06-49974678 | stefania.basili@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Violi, Full Prof | Divisione di Prima Clinica Medica - Sapienza University of Rome | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza Università di Roma | Recruiting | Rome | Italy | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15917194 | Background | Pignatelli P, Sanguigni V, Paola SG, Lo Coco E, Lenti L, Violi F. Vitamin C inhibits platelet expression of CD40 ligand. Free Radic Biol Med. 2005 Jun 15;38(12):1662-6. doi: 10.1016/j.freeradbiomed.2005.02.032. Epub 2005 Mar 23. | |
| 7073791 | Background | Cordova C, Musca A, Violi F, Perrone A, Alessandri C. Influence of ascorbic acid on platelet aggregation in vitro and in vivo. Atherosclerosis. 1982 Jan;41(1):15-9. doi: 10.1016/0021-9150(82)90064-8. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention. |
|
|
Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) could improve the reperfusion indexes. |
| post PCI |
| Early incidence of Major Adverse Cardiovascular Events. | Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack | 1 month |
| Late incidence of Major Adverse Cardiovascular Events. | Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack | 3 months |
| 20170881 | Background | Basili S, Tanzilli G, Mangieri E, Raparelli V, Di Santo S, Pignatelli P, Violi F. Intravenous ascorbic acid infusion improves myocardial perfusion grade during elective percutaneous coronary intervention: relationship with oxidative stress markers. JACC Cardiovasc Interv. 2010 Feb;3(2):221-9. doi: 10.1016/j.jcin.2009.10.025. |
| 19336704 | Background | Violi F, Cangemi R. Antioxidant supplements and cardiovascular disease in men. JAMA. 2009 Apr 1;301(13):1335; author reply 1336-7. doi: 10.1001/jama.2009.314. No abstract available. |
| 17664149 | Background | Cangemi R, Angelico F, Loffredo L, Del Ben M, Pignatelli P, Martini A, Violi F. Oxidative stress-mediated arterial dysfunction in patients with metabolic syndrome: Effect of ascorbic acid. Free Radic Biol Med. 2007 Sep 1;43(5):853-9. doi: 10.1016/j.freeradbiomed.2007.06.002. Epub 2007 Jun 13. |
| 21636808 | Background | Basili S, Pignatelli P, Tanzilli G, Mangieri E, Carnevale R, Nocella C, Di Santo S, Pastori D, Ferroni P, Violi F. Anoxia-reoxygenation enhances platelet thromboxane A2 production via reactive oxygen species-generated NOX2: effect in patients undergoing elective percutaneous coronary intervention. Arterioscler Thromb Vasc Biol. 2011 Aug;31(8):1766-71. doi: 10.1161/ATVBAHA.111.227959. Epub 2011 Jun 2. |
| 25074252 | Background | Basili S, Tanzilli G, Raparelli V, Calvieri C, Pignatelli P, Carnevale R, Dominici M, Placanica A, Arrivi A, Farcomeni A, Barilla F, Mangieri E, Violi F. Aspirin reload before elective percutaneous coronary intervention: impact on serum thromboxane b2 and myocardial reperfusion indexes. Circ Cardiovasc Interv. 2014 Aug;7(4):577-84. doi: 10.1161/CIRCINTERVENTIONS.113.001197. Epub 2014 Jul 29. |
| 20629665 | Result | Pignatelli P, Tanzilli G, Carnevale R, Di Santo S, Loffredo L, Celestini A, Proietti M, Tovaglia P, Mangieri E, Basili S, Violi F. Ascorbic acid infusion blunts CD40L upregulation in patients undergoing coronary stent. Cardiovasc Ther. 2011 Dec;29(6):385-94. doi: 10.1111/j.1755-5922.2010.00168.x. Epub 2010 Jul 12. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |