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Effects of Melatonin on Reperfusion Injury

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03303378
Collaborator
(none)
190
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)
  • Drug: Placebos
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary interventionPatients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Anticipated Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The salvage index [3 months after primary percutaneous coronary intervention]

      The salvage index measured by cardiac magnetic resonance

    Secondary Outcome Measures

    1. The final infarct size [3 months after primary percutaneous coronary intervention]

      The final infarct size measured by cardiac magnetic resonance

    2. major adverse cardiovascular events (MACE) [3 months after primary percutaneous coronary intervention]

      recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.

    3. treatment-emergent adverse events (TEAEs) [3 months after primary percutaneous coronary intervention]

      hypoglycemia, nausea

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chen Wei Ren, MD, doctor, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT03303378
    Other Study ID Numbers:
    • MelonRI
    First Posted:
    Oct 6, 2017
    Last Update Posted:
    Oct 6, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chen Wei Ren, MD, doctor, Chinese PLA General Hospital
    melatonin
    Reperfusion Injury
    myocardial infarction
    Additional relevant MeSH terms:
    Reperfusion Injury
    Myocardial Reperfusion Injury
    Wounds and Injuries
    Melatonin

    Study Results

    No Results Posted as of Oct 6, 2017