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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Sponsor:
Information provided by (Responsible Party):
Alberto Dominguez-Rodriguez, MD, PhD, FESC, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT00640094
First received: March 12, 2008
Last updated: September 26, 2014
Last verified: September 2014

March 12, 2008
September 26, 2014
May 2013
November 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00640094 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty
A Unicentric, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Melatonin as an Adjunct in Patients With Acute myocaRdial Infarction Undergoing Primary Angioplasty

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 unicentric, 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.

See article for more detailed description: Contemporary Clinical Trials 28 (2007) 532-539

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
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 microMolar melatonin during 150 minutes with a drip rate of 4.2 ml/min.
Experimental: A
Intervention: Drug: melatonin
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.
 
Recruiting
272
November 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged between 18 and 75 years.
  2. Having experienced continuous ischemic (cardiac) symptoms for at least 20 minutes.
  3. Having onset of symptoms of qualifying acute myocardial infarction within the past 6 hours and be expected to undergo primary angioplasty.
  4. 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.

  5. 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).
  6. 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:

  1. prehospital thrombolysis,
  2. Killip class IV on admission,
  3. known history of prior myocardial infarction,
  4. known history of renal failure,
  5. history of severe allergic reaction,
  6. history of autoimmune diseases,
  7. pregnancy,
  8. severe concurrent illness with reduced short-term prognosis,
  9. inability to give informed consent and
  10. participation in another study within the past 30 days.
Both
18 Years to 75 Years
No
Contact: Alberto Dominguez-Rodriguez, MD, PhD, FESC +34 922 679030 adrvdg@hotmail.com
Spain
 
NCT00640094
2005-000821-49
Yes
Alberto Dominguez-Rodriguez, MD, PhD, FESC, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Alberto Dominguez-Rodriguez, MD, PhD, FESC
Not Provided
Principal Investigator: Alberto Dominguez-Rodriguez, MD, PhD, FESC
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP