The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty (MARIA)

Tracking Information
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; (submitted: April 21, 2016)	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
Original Primary Outcome Measures ICMJE; (submitted: March 19, 2008)	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; (submitted: April 21, 2016)	Major cardiac events: 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 year ]; Changes in left ventricular ejection fraction evaluated by cardiac magnetic resonance [ Time Frame: 4 months ]
Original Secondary Outcome Measures ICMJE; (submitted: March 19, 2008)	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.
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
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
Study Arms	Experimental: A: Melatonin Melatonin: intravenous infusion and intracoronary bolus Intervention: Drug: melatonin; Placebo Comparator: B: Placebo of melatonin Placebo: intravenosus infusion and intracoronary bolus Intervention: Drug: melatonin
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.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 19, 2008)	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: Aged between 18 and 75 years.; Having experienced continuous ischemic (cardiac) symptoms for at least 20 minutes.; Having onset of symptoms of qualifying acute myocardial infarction within the past 6 hours and be expected to undergo primary angioplasty.; Having an electrocardiogram indicative of an acute ST segment -elevation myocardial infarction showing: > 2 mm ST segment elevation in 2 anterior or lateral leads; or > 2 mm ST segment 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.; Being willing to provide informed consent (informed consent may be provided by a legally authorized representative if the patient is not able to provide it according to local ethical standards).; Being willing and able to be followed for at least 3 months for evaluation. Exclusion Criteria: A patient will be ineligible for study entry if he/she meets any of the following criteria: prehospital thrombolysis,; Killip class IV on admission,; known history of prior myocardial infarction,; known history of renal failure,; history of severe allergic reaction,; history of autoimmune diseases,; pregnancy,; severe concurrent illness with reduced short-term prognosis,; inability to give informed consent and; participation in another study within the past 30 days.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
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	Principal Investigator: Alberto Dominguez-Rodriguez, MD, PhD, FESC
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