The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty (MARIA)
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ClinicalTrials.gov Identifier: NCT00640094 |
Recruitment Status
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Terminated
First Posted
: March 20, 2008
Last Update Posted
: July 25, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | March 12, 2008 | |||
First Posted Date ICMJE | March 20, 2008 | |||
Last Update Posted Date | July 25, 2016 | |||
Study Start Date ICMJE | May 2013 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Infarct size [ Time Frame: 5-7 days post-reperfusion ] The primary efficacy end point in this study is to determine whether melatonin treatment reduces infarct size (percentage of total myocardial necrotic mass) by cardiac magnetic resonance
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Original Primary Outcome Measures ICMJE |
The primary efficacy end point in this study is to determine whether melatonin treatment reduces of infarct size as determined by the cumulative release of alpha-hydroxybutyrate dehydrogenase. [ Time Frame: within the first 72 hours ] | |||
Change History | Complete list of historical versions of study NCT00640094 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Death, sustained ventricular arrhythmias, resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings, stroke, need for revascularization, recurrent ischemia, re-infarctions and re-hospitalization. [ Time Frame: within the first 90 days ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty | |||
Official Title ICMJE | Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Melatonin as an Adjunct in Patients With Acute myocaRdial Infarction Undergoing Primary Angioplasty | |||
Brief Summary | 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 a 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 cardiac magnetic resonance 5-7 days post-reperfusion. Other secondary end points will be the clinical events occurring within the first year: death, sustained ventricular arrhythmias, resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings , stroke, need for revascularization, recurrent ischemia, re-infarctions and rehospitalization; and changes in left ventricular ejection fraction from baseline to 4 months of follow-up. 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. |
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Detailed Description | See article for more detailed description: Contemporary Clinical Trials 28 (2007) 532-539 | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myocardial Infarction | |||
Intervention ICMJE | Drug: melatonin
Patients will receive a total intravenous melatonin dose of 12 mg + intracoronary melatonin dose of 2 mg. The intravenous dose will be distributed in a volume of 50 ml of a isotonic and sterile solution and administered by intravenous infusion during 60 minutes. The intracoronary dose will be distributed in a volume of 10 ml of a isotonic and sterile solution and administered as a bolus.
Other Name: 5-methoxy-tryptamine |
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Study Arms |
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Publications * | Dominguez-Rodriguez A, Abreu-Gonzalez P, Garcia-Gonzalez MJ, Kaski JC, Reiter RJ, Jimenez-Sosa A. A unicenter, randomized, double-blind, parallel-group, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction undergoing primary Angioplasty The Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty (MARIA) trial: study design and rationale. Contemp Clin Trials. 2007 Jul;28(4):532-9. Epub 2006 Oct 17. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
272 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | November 2016 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: A patient will be ineligible for study entry if he/she meets any of the following criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640094 | |||
Other Study ID Numbers ICMJE | 2005-000821-49 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Alberto Domínguez Rodríguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica | |||
Study Sponsor ICMJE | Alberto Domínguez Rodríguez | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Fundación Canaria Rafael Clavijo para la Investigación Biomédica | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |