The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty

NCT ID: NCT00640094

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-11-30

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

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A: Melatonin

Melatonin: intravenous infusion and intracoronary bolus

Group Type: EXPERIMENTAL

melatonin

Intervention Type: DRUG

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.

B: Placebo of melatonin

Placebo: intravenosus infusion and intracoronary bolus

Group Type: PLACEBO_COMPARATOR

melatonin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

5-methoxy-tryptamine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberto Domínguez Rodríguez

OTHER

Sponsor Role: lead

Responsible Party

Alberto Domínguez Rodríguez

MD, PhD, FESC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alberto Dominguez-Rodriguez, MD, PhD, FESC

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital General Universitario Santa Lucia

Cartagena, Murcia, Spain

University Hospital of Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Countries

Spain

References

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. doi: 10.1016/j.cct.2006.10.007. Epub 2006 Oct 17.

Reference Type: RESULT

PMID: 17123867 (View on PubMed)

Other Identifiers

2005-000821-49

Identifier Type: -

Identifier Source: org_study_id