Effects of Melatonin on Reperfusion Injury

October 4, 2017 updated by: Chen Wei Ren, MD, Chinese PLA General Hospital

Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention

Exclusion Criteria:

  • unconscious at presentation
  • had cardiogenic shock
  • had a history of myocardial infarction
  • stent thrombosis
  • renal insufficiency
  • had previously undergone coronary artery bypass surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Melatonin group
Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).
Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)

Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min.

The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).

Other Names:
  • melatonin
PLACEBO_COMPARATOR: Control group
Patients will receive the same dose of placebo.
Drug: Placebos
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The salvage index
Time Frame: 3 months after primary percutaneous coronary intervention
The salvage index measured by cardiac magnetic resonance
3 months after primary percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The final infarct size
Time Frame: 3 months after primary percutaneous coronary intervention
The final infarct size measured by cardiac magnetic resonance
3 months after primary percutaneous coronary intervention
major adverse cardiovascular events (MACE)
Time Frame: 3 months after primary percutaneous coronary intervention
recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.
3 months after primary percutaneous coronary intervention
treatment-emergent adverse events (TEAEs)
Time Frame: 3 months after primary percutaneous coronary intervention
hypoglycemia, nausea
3 months after primary percutaneous coronary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2017

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (ACTUAL)

October 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MelonRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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