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| Sponsored by: |
Fundación Canaria Rafael Clavijo para la Investigación Biomédica |
| Information provided by: | Fundación Canaria Rafael Clavijo para la Investigación Biomédica |
| ClinicalTrials.gov Identifier: | NCT00640094 |
Purpose
Background: Experimental studies have documented the beneficial effects of the endogenously produced antioxidant, melatonin, in reducing tissue damage and limiting cardiac pathophysiology in models of experimental ischemia-reperfusion. Melatonin confers cardioprotection against ischemia-reperfusion injury most likely through its direct free radical scavenging activities and its indirect actions in stimulating antioxidant enzymes. These actions of melatonin permit it to reduce molecular damage and limit infarct size in experimental models of transient ischemia and subsequent reperfusion.
Study design: The Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty (MARIA) trial is an unicenter, prospective, randomized, double-blind, placebo-controlled, phase 2 study of the intravenous administration of melatonin. The primary efficacy end point of this study is to determine whether melatonin treatment reduces infarct size determined by the cumulative release of alpha-hydroxybutyrate dehydrogenase (area under the curve: 0 to 72 h). Other secondary end points will be the clinical events occurring within the first 90 days: death, sustained ventricular arrhythmias, resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings , stroke, need for revascularization, recurrent ischemia, re-infarctions and rehospitalization.
Implications: The MARIA trial tests a novel pharmacologic agent, melatonin, in patients with acute myocardial infarction and the hypothesis that it will confer cardioprotection against ischemia-reperfusion injury. If successful, the finding would support the use of melatonin in therapy of ischemic-reperfusion injury of the heart.
| Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Drug: melatonin |
Phase II |
| MedlinePlus related topics: | Angioplasty Antioxidants Heart Attack Heart Failure |
| ChemIDplus related topics: | Melatonin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Unicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Melatonin as an Adjunct in Patients With Acute myocaRdial Infarction Undergoing Primary Angioplasty |
| Estimated Enrollment: | 272 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental |
Drug: melatonin
Patients will receive a total intravenous melatonin dose of 11.61 mg (approximately 166 microgram/kg) or placebo. The dose will be distributed in a volume of 500 ml of a isotonic and sterile solution of 100 microM melatonin during 150 minutes with a drip rate of 4.2 ml/min.
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See article for more detailed description: Contemporary Clinical Trials 28 (2007) 532-539
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Having an electrocardiogram indicative of an acute ST-elevation myocardial infarction showing:
> 2 mm ST elevation in 2 anterior or lateral leads; or > 2 mm ST elevation in 2 inferior leads coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of > 8 mm; or new left bundle branch block with at least 1 mm concordant ST elevation.
Exclusion Criteria:
A patient will be ineligible for study entry if he/she meets any of the following criteria:
Contacts and Locations| Contact: Alberto Dominguez-Rodriguez, MD, PhD, FESC | +34 922 679030 | adrvdg@hotmail.com |
| Spain, Tenerife | |||||
| University Hospital of Canarias | Active, not recruiting | ||||
| La Laguna, Tenerife, Spain, E-38320 | |||||
| Fundación Canaria Rafael Clavijo para la Investigación Biomédica |
| Principal Investigator: | Alberto Dominguez-Rodriguez, MD, PhD, FESC | Unaffiliated. |
More Information
| Responsible Party: | University Hospital of Canarias ( Alberto Dominguez Rodriguez ) |
| Study ID Numbers: | 2005-000821-49 |
| First Received: | March 12, 2008 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00640094 |
| Health Authority: | United States: Food and Drug Administration; Spain: Ethics Committee; Spain: Ministry of Health; Spain: Spanish Agency of Medicines |
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