Acute Myocardial InfarctionPhase 2MARIANCT00640094
The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty
A Phase 2 study testing melatonin in people with Acute Myocardial Infarction, run by Alberto Domínguez Rodríguez at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- melatonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 3 sitesSpain
- Study dates
- May 2013to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital General Universitario Santa Lucia
Cartagena, Murcia, 30202
University Hospital of Canarias
San Cristóbal de La Laguna, Tenerife, E-38320
Hospital Universitario Marqués de Valdecilla
Santander
About this study
Official title: 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 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.
Read the detailed description
See article for more detailed description: Contemporary Clinical Trials 28 (2007) 532-539
- Conditions
- Acute Myocardial Infarction
- Being tested
- melatonin
- Keywords
- Melatonin, Acute myocardial infarction, Primary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Also called 5-methoxy-tryptamine
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.
| Study group | Role | What they receive |
|---|---|---|
| A: Melatonin | Experimental | Melatonin: intravenous infusion and intracoronary bolus Receives: Drug: melatonin |
| B: Placebo of melatonin | Placebo comparator | Placebo: intravenosus infusion and intracoronary bolus Receives: Drug: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
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
Measured: 5-7 days post-reperfusion
Secondary outcomes (2)
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.
Measured: within the first year
Changes in left ventricular ejection fraction evaluated by cardiac magnetic resonance
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMay 2013
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberto Domínguez Rodríguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alberto Domínguez Rodríguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Investigators
- Alberto Dominguez-Rodriguez, MD, PhD, FESC, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640094
- Sponsor's protocol ID
- 2005-000821-49
- Other IDs
- 2005
- Acronym
- MARIA
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2008
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.cct.2006.10.007. Epub 2006 Oct 17.
PubMed 17123867
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Melatonin as an Adjunct in Patients With Acute myocaRdial Infarction Undergoing Primary Angioplasty
- ClinicalTrials.gov ID
- NCT00640094
- Acronym / sponsor ID
- MARIA / 2005-000821-49
- Conditions
- Acute Myocardial Infarction
- Keywords
- Melatonin, Acute myocardial infarction, Primary angioplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Alberto Domínguez RodríguezUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Melatonin | Experimental | Drug: melatoninMelatonin: intravenous infusion and intracoronary bolus |
| B: Placebo of melatonin | Placebo comparator | Drug: melatoninPlacebo: intravenosus infusion and intracoronary bolus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninAlso: 5-methoxy-tryptaminePatients 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. | Drug | A: Melatonin, B: Placebo of melatonin |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Results publication: PubMed 17123867Dominguez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Dominguez-Rodriguez, MD, PhD, FESC principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin in people with Acute Myocardial Infarction, run by Alberto Domínguez Rodríguez at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size (time frame: 5-7 days post-reperfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.